123-425: A biologics license application ( BLA ) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for
246-412: A U.S. state or Washington, D.C. can vote in presidential elections. Puerto Rico has eight senatorial districts , 40 representative districts , and 78 municipalities ; there are no first-order administrative divisions as defined by the U.S. government. Municipalities are subdivided into wards or barrios , and those into sectors. Each municipality has a mayor and a municipal legislature elected for
369-743: A medical practitioner 's supervision like ibuprofen . In 2014, the FDA added an Ebola treatment being developed by Canadian pharmaceutical company Tekmira to the Fast Track program , but halted the phase 1 trials in July pending the receipt of more information about how the drug works. This was widely viewed as increasingly important in the face of a major outbreak of the disease in West Africa that began in late March 2014 and ended in June 2016. During
492-503: A nonvoting representative to the U.S. Congress , called a Resident Commissioner , and participates in presidential primaries ; as it is not a state, Puerto Rico does not have a vote in the U.S. Congress , which oversees it under the Puerto Rico Federal Relations Act of 1950 . Congress approved a territorial constitution in 1952, allowing residents of the archipelago to elect a governor in addition to
615-655: A senate and house of representatives . The political status of Puerto Rico is an ongoing debate . Beginning in the mid-20th century, the U.S. government , together with the Puerto Rico Industrial Development Company , launched a series of economic projects to develop Puerto Rico into an industrial high-income economy. It is classified by the International Monetary Fund as a developed jurisdiction with an advanced, high-income economy ; it ranks 40th on
738-460: A "FDA Compliant" or "FDA Acceptable". Medical countermeasures (MCMs) are products such as biologics and pharmaceutical drugs that can protect from or treat the health effects of a chemical, biological, radiological, or nuclear (CBRN) attack. MCMs can also be used for prevention and diagnosis of symptoms associated with CBRN attacks or threats. The FDA runs a program called the "FDA Medical Countermeasures Initiative" (MCMi), with programs funded by
861-425: A REMS program called iPLEDGE . Generic drugs are chemical and therapeutic equivalents of name-brand drugs, normally whose patents have expired. Approved generic drugs should have the same dosage, safety, effectiveness, strength, stability, and quality, as well as route of administration. In general, they are less expensive than their name brand counterparts, are manufactured and marketed by rival companies and, in
984-499: A binding referendum. The bill does not decide PR's fate, it simply prepares the United States to respond the outcome of referendum. In the 5 November 2024 elections, there was three choices in a non-binding referendum which included Statehood, Independence, or Independence with Free Association on the ballot; Statehood won with 59%. In addition, on November 5, 2024, Jennifer Gonzalez won the office of Governor of Puerto Rico in
1107-704: A case. The FDA has a number of field offices across the United States, in addition to international locations in China, India, Europe, the Middle East, and Latin America. As of 2021, the FDA had responsibility for overseeing $ 2.7 trillion in food, medical, and tobacco products. Some 54% of its budget derives from the federal government, and 46% is covered by industry user fees for FDA services. For example, pharmaceutical firms pay fees to expedite drug reviews. According to Forbes, pharmaceutical firms provide 75% of
1230-527: A company may advertise or promote a drug only for the specific indication or medical use for which it was approved by FDA. Also, an advertisement must contain a "fair balance" between the benefits and the risks (side effects) of a drug. The regulation of drug advertising in the U.S. is divided between the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), based on whether
1353-426: A complaint brought against the FDA by Mylan Laboratories Inc. of Pittsburgh . When its application to manufacture generics were subjected to repeated delays by the FDA, Mylan, convinced that it was being discriminated against, soon began its own private investigation of the agency in 1987. Mylan eventually filed suit against two former FDA employees and four drug-manufacturing companies, charging that corruption within
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#17327874126871476-467: A four-year term. The municipality of San Juan is the oldest, founded in 1521; the next earliest settlements are San Germán in 1570, Coamo in 1579, Arecibo in 1614, Aguada in 1692 and Ponce in 1692. Increased settlement in the 18th century saw 30 more communities established, following 34 in the 19th century. Six were founded in the 20th century, the most recent being Florida in 1971. Since 1952, Puerto Rico has had three main political parties:
1599-468: A license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA. This includes: Some biological products are regulated by the Center for Drug Evaluation and Research (CDER) while others are regulated by the Center for Biologics Evaluation and Research (CBER). A BLA is submitted after the investigational new drug (IND) phase, once
1722-767: A long history of service in the U.S. Armed Forces and, since 1917, they have been included in the U.S. compulsory draft when it has been in effect. Though the Commonwealth government has its own tax laws, residents of Puerto Rico, contrary to a popular misconception, do pay U.S. federal taxes: customs taxes (which are subsequently returned to the Puerto Rico Treasury), import/export taxes, federal commodity taxes, social security taxes, etc. Residents pay federal payroll taxes , such as Social Security and Medicare , as well as Commonwealth of Puerto Rico income taxes. All federal employees, those who do business with
1845-432: A long period of time. The studies are progressively longer, gradually adding more individuals as they progress from stage I to stage III, normally over a period of years, and normally involve drug companies, the government and its laboratories, and often medical schools and hospitals and clinics. However, any exceptions to the aforementioned process are subject to strict review and scrutiny and conditions, and are only given if
1968-560: A new master plan for this expansion in December 2018, and construction is expected to be completed by 2035, dependent on GSA appropriations. The Office of Regulatory Affairs is considered the agency's "eyes and ears", conducting the vast majority of the FDA's work in the field. Its employees, known as Consumer Safety Officers, or more commonly known simply as investigators, inspect production, warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in
2091-651: A number of Resident Posts, which are FDA remote offices that serve a particular geographic area. ORA also includes the Agency's network of regulatory laboratories, which analyze any physical samples taken. Though samples are usually food-related, some laboratories are equipped to analyze drugs, cosmetics, and radiation-emitting devices. The Office of Criminal Investigations was established in 1991 to investigate criminal cases. To do so, OCI employs approximately 200 Special Agents nationwide who, unlike ORA Investigators, are armed, have badges, and do not focus on technical aspects of
2214-498: A role in monitoring safety through influence on ingredients, but they lack legal authority. According to the ACSH, it has reviewed about 1,200 ingredients and has suggested that several hundred be restricted—but there is no standard or systemic method for reviewing chemicals for safety, or a clear definition of what 'safety' even means so that all chemicals get tested on the same basis. However, on December 29, 2022, President Biden signed
2337-523: A satisfied requirement. The FDA does not approve applied coatings used in the food processing industry . There is no review process to approve the composition of nonstick coatings; nor does the FDA inspect or test these materials. Through their governing of processes, however, the FDA does have a set of regulations that cover the formulation, manufacturing, and use of nonstick coatings. Hence, materials like Polytetrafluoroethylene (Teflon) are not and cannot be considered as FDA Approved, but rather, they are
2460-648: A significant degree of federal control involved in its establishment and operations. In particular, the authority to establish the control board derives from the federal government's constitutional power to "make all needful rules and regulations" regarding U.S. territories; The president would appoint all seven voting members of the board; and the board would have broad sovereign powers to effectively overrule decisions by Puerto Rico's legislature, governor, and other public authorities. There would be another referendum in 2017 in Puerto Rico, in favor of statehood although it
2583-440: A substantial amount of research and at least some preliminary human testing has shown that they are believed to be somewhat safe and possibly effective. (See FDA Special Protocol Assessment about Phase III trials.) The FDA's Office of Prescription Drug Promotion (OPDP) has responsibilities that revolve around the review and regulation of prescription drug advertising and promotion. This is achieved through surveillance activities and
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#17327874126872706-502: A territory of the United States, exercising substantial internal self-government, but subordinated to the U.S. Constitution in areas such as foreign affairs or defense. For this reason, it is not considered to be a full-fledged associated state under either international or U.S. domestic law. The history of Puerto Rico began with the settlement of the Ortoiroid people before 430 BC. At the time of Christopher Columbus 's arrival in
2829-561: A warning to that effect. According to the industry advocacy group, the American Council on Science and Health , though the cosmetic industry is primarily responsible for its own product safety, the FDA can intervene when necessary to protect the public. In general, though, cosmetics do not require pre-market approval or testing. The ACSH says that companies must place a warning note on their products if they have not been tested, and that experts in cosmetic ingredient review also play
2952-401: Is a center of the FDA that regulates food additives and drugs that are given to animals. CVM regulates animal drugs, animal food including pet animal, and animal medical devices. The FDA's requirements to prevent the spread of bovine spongiform encephalopathy are also administered by CVM through inspections of feed manufacturers. CVM does not regulate vaccines for animals; these are handled by
3075-651: Is a separate process, and the drug must be approved through an NDA first. A drug that is approved is said to be "safe and effective when used as directed". Very rare, limited exceptions to this multi-step process involving animal testing and controlled clinical trials can be granted out of compassionate use protocols. This was the case during the 2015 Ebola epidemic with the use, by prescription and authorization, of ZMapp and other experimental treatments, and for new drugs that can be used to treat debilitating and/or very rare conditions for which no existing remedies or drugs are satisfactory, or where there has not been an advance in
3198-564: Is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs but involves other factors like regulating lasers , cellular phones , and condoms . In addition, the FDA takes control of diseases in
3321-581: Is headed by the governor , currently Pedro Pierluisi Urrutia . The legislative branch consists of the bicameral Legislative Assembly , made up of a Senate as its upper chamber and a House of Representatives as its lower chamber; the Senate is headed by a president , currently José Luis Dalmau , while the House is headed by the speaker of the House , currently Tatito Hernández . The governor and legislators are elected by popular vote every four years, with
3444-482: Is land and 1,900 sq mi (4,900 km ) is water. Puerto Rico is larger than Delaware and Rhode Island but smaller than Connecticut . The maximum length of the main island from east to west is 110 mi (180 km), and the maximum width from north to south is 40 mi (64 km). Puerto Rico is the smallest of the Greater Antilles . It is 80% of the size of Jamaica , just over 18% of
3567-745: Is located in the White Oak area of Silver Spring, Maryland . The agency has 223 field offices and 13 laboratories located across the 50 states, the United States Virgin Islands , and Puerto Rico . In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom. FDA headquarters facilities are currently located in Montgomery County and Prince George's County , Maryland. Since 1990,
3690-630: Is located in this range. Another important peak is El Yunque , one of the highest in the Sierra de Luquillo at the El Yunque National Forest , with an elevation of 3,494 ft (1,065 m). Puerto Rico has 17 lakes, all man-made, and more than 50 rivers , most of which originate in the Cordillera Central. Rivers in the northern region of the island are typically longer and of higher water flow rates than those of
3813-492: Is the coquí , a small frog easily identified by the sound of its call, from which it gets its name. Most coquí species (13 of 17) live in the El Yunque National Forest , the only tropical rainforest in the U.S. Forest Service system, located in the northeast of the island. It was previously known as the Caribbean National Forest. El Yunque is home to more than 240 plants, 26 of which are endemic to
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3936-449: Is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents. These include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products. New biologics are required to go through a premarket approval process called a Biologics License Application (BLA), similar to that for drugs. The original authority for government regulation of biological products
4059-741: Is the branch of the FDA responsible for the premarket approval of all medical devices , as well as overseeing the manufacturing, performance and safety of these devices. The definition of a medical device is given in the FD&;C Act, and it includes products from the simple toothbrush to complex devices such as implantable neurostimulators . CDRH also oversees the safety performance of non-medical devices that emit certain types of electromagnetic radiation . Examples of CDRH-regulated devices include cellular phones , airport baggage screening equipment , television receivers , microwave ovens , tanning booths , and laser products . CDRH regulatory powers include
4182-702: Is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to new molecular entities : drugs that are not based on existing medications. New drugs receive extensive scrutiny before FDA approval in a process called a new drug application (NDA). Under the Presidency of Donald Trump , the agency has worked to make the drug-approval process go faster. Critics, however, argue that FDA standards are not sufficiently rigorous to prevent unsafe or ineffective drugs from getting approval. New drugs are available only by prescription by default. A change to over-the-counter (OTC) status
4305-451: Is voluntary. While this remains the primary tool of post-market safety surveillance , FDA requirements for post-marketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional clinical trials , called Phase IV trials. In some cases, the FDA requires risk management plans called Risk Evaluation and Mitigation Strategies (REMS) for some drugs that require actions to be taken to ensure that
4428-559: The American model , with separation of powers subject to the jurisdiction and sovereignty of the United States. All governmental powers are delegated by the United States Congress , with the head of state being the president of the United States . As an unincorporated territory , Puerto Rico lacks full protection under the U.S. Constitution. The government of Puerto Rico is composed of three branches. The executive
4551-659: The Cabo Rojo , Desecheo , Culebra and Vieques National Wildlife Refuges , and in the Caja de Muertos and Mona and Monito Islands Nature Reserves . Examples of endemic species found in this ecoregion are the higo chumbo ( Harrisia portoricensis ), the Puerto Rican crested toad ( Peltophryne lemur ), and the Mona ground iguana ( Cyclura stejnegeri ), the largest land animal native to Puerto Rico. Puerto Rico has three of
4674-633: The Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER) and offices for the Center for Veterinary Medicine (CVM). With the passing of the FDA Reauthorization Act of 2017, the FDA projects a 64% increase in employees to 18,000 over the next 15 years and wants to add approximately 1,600,000 square feet (150,000 square metres) of office and special use space to their existing facilities. The National Capital Planning Commission approved
4797-716: The Commonwealth of Puerto Rico , is a self-governing Caribbean archipelago and island organized as an unincorporated territory of the United States under the designation of commonwealth . Located about 1,000 miles (1,600 km) southeast of Miami , Florida , between the Dominican Republic in the Greater Antilles and the U.S. Virgin Islands in the Lesser Antilles , it consists of
4920-552: The Department of War . A U.S. Supreme Court ruling, Ortega v. Lara , 202 U.S. 339, 342 (1906), involving the Foraker Act and referring to the island as "the acquired country", soon affirmed that the U.S. Constitution applied within its territory and that any domestic Puerto Rican laws which did not conflict with it remained in force. The Jones Act of 1917, which made Puerto Ricans U.S. citizens , paved
5043-518: The Greater Antilles , Puerto Rico was a stepping-stone in the passage from Europe to Cuba, Mexico, Central America, and the northern territories of South America. Throughout most of the 19th century until the conclusion of the Spanish–American War , Puerto Rico and Cuba were the last two Spanish colonies in the New World; they served as Spain's final outposts in a strategy to regain control of
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5166-491: The Human Development Index . The major sectors of Puerto Rico's economy are manufacturing , primarily pharmaceuticals , petrochemicals , and electronics, followed by services , namely tourism and hospitality. Puerto Rico is Spanish for "rich port". Puerto Ricans often call the island Borinquen , a derivation of Borikén , its Indigenous Taíno name, which is popularly said to mean "Land of
5289-471: The Köppen climate classification is mostly tropical rainforest . Temperatures are warm to hot year round, averaging near 85 °F (29 °C) in lower elevations and 70 °F (21 °C) in the mountains. Easterly trade winds pass across the island year round. Puerto Rico has a rainy season , which stretches from April into November, and a dry season stretching from December to March. The mountains of
5412-612: The New World in 1493, the dominant indigenous culture was that of the Taínos . The Taíno people's numbers went dangerously low during the later half of the 16th century because of new infectious diseases carried by Europeans, exploitation by Spanish settlers, and warfare. Located in the northeastern Caribbean, Puerto Rico formed a key part of the Spanish Empire from the early years of the exploration, conquest and colonization of
5535-545: The New World . The island was a major military post during many wars between Spain and other European powers for control of the region in the 16th, 17th and 18th centuries. In 1593, Portuguese soldiers, sent from Lisbon by order of Phillip II, composed the first garrison of the San Felipe del Morro fortress in Puerto Rico. Some brought their wives, while others married Puerto Rican women, and today there are many Puerto Rican families with Portuguese last names. The smallest of
5658-856: The Popular Democratic Party (PPD in Spanish), the New Progressive Party (PNP in Spanish) and the Puerto Rican Independence Party (PIP). The three parties stand for different political status. The PPD, for example, seeks to maintain the island's status with the U.S. as a commonwealth , while the PNP seeks to make Puerto Rico a U.S. state . Meanwhile, the PIP seeks to make Puerto Rico a sovereign nation free from U.S. authority. In terms of party strength,
5781-638: The Puerto Rico Department of Natural Resources . There are many other even smaller islets , like Monito , located near Mona, and Isla de Cabras and La Isleta de San Juan , both located on the San Juan Bay . The latter is the only inhabited islet with communities like Old San Juan and Puerta de Tierra , which are connected to the main island by bridges. The Commonwealth of Puerto Rico has an area of 5,320 square miles (13,800 km ), of which 3,420 sq mi (8,900 km )
5904-589: The U.S. Treasury . Residents of Puerto Rico pay into Social Security, and are thus eligible for Social Security benefits upon retirement. They are excluded from the Supplemental Security Income , and the island receives a smaller fraction of the Medicaid funding it would receive if it were a U.S. state. Also, Medicare providers receive less-than-full state-like reimbursements for services rendered to beneficiaries in Puerto Rico, even though
6027-631: The UNESCO Man and the Biosphere Programme : Luquillo Biosphere Reserve represented by El Yunque National Forest and the Guánica Biosphere Reserve . Species endemic to the archipelago number 239 plants, 16 birds and 39 amphibians / reptiles , recognized as of 1998. Most of these (234, 12 and 33 respectively) are found on the main island. The most recognizable endemic species and a symbol of Puerto Rican pride
6150-498: The United States Department of Agriculture . The FDA regulates tobacco products with authority established by the 2009 Family Smoking Prevention and Tobacco Control Act . This Act requires color warnings on cigarette packages and printed advertising, and text warnings from the U.S. Surgeon General . Puerto Rico Puerto Rico ( Spanish for 'rich port'; abbreviated PR ), officially
6273-643: The coronavirus pandemic , FDA granted emergency use authorization for personal protective equipment (PPE), in vitro diagnostic equipment, ventilators and other medical devices. On March 18, 2020, FDA inspectors postponed most foreign facility inspections and all domestic routine surveillance facility inspections. In contrast, the USDA's Food Safety and Inspection Service (FSIS) continued inspections of meatpacking plants, which resulted in 145 FSIS field employees who tested positive for COVID-19, and three who died. The Center for Biologics Evaluation and Research
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#17327874126876396-497: The eponymous main island and numerous smaller islands, including Vieques , Culebra , and Mona . With approximately 3.2 million residents , it is divided into 78 municipalities , of which the most populous is the capital municipality of San Juan , followed by those within the San Juan metropolitan area . Spanish and English are the official languages of the government , though Spanish predominates. Puerto Rico
6519-606: The '2023 Consolidated Budget Act', which includes the 'Cosmetics Regulatory Modernization Act of 2022 (MoCRA)', which is a stricter regulation that is different from the previous regulations. MoCRA requires compliance with matters such as serious adverse event reporting, safety substantiation, additional labeling, record keeping, and Good Manufacturing Practices (GMP). MoCRA also calls on the FDA to grant Mandatory Recall Authority and establish regulations for GMP rules, flavor allergen labeling rules, and testing methods for cosmetics containing talc. The Center for Veterinary Medicine (CVM)
6642-406: The 1990s, accounted for about a third of all prescriptions written in the United States. For a pharmaceutical company to gain approval to produce a generic drug, the FDA requires scientific evidence that the generic drug is interchangeable with or therapeutically equivalent to the originally approved drug. This is called an Abbreviated New Drug Application (ANDA). 80% of prescription drugs sold in
6765-892: The 2008 general election. Four years later, the 2012 election saw the emergence of the Movimiento Unión Soberanista (English: Sovereign Union Movement) and the Partido del Pueblo Trabajador (English: Working People's Party) but none obtained more than 1% of the vote. Other non-registered parties include the Puerto Rican Nationalist Party , the Socialist Workers Movement , and the Hostosian National Independence Movement . The nature of Puerto Rico's political relationship with
6888-416: The 2024 general election, with nearly 40% of the vote, who is pro-statehood. Puerto Rico consists of the main island of Puerto Rico and various smaller islands, including Vieques , Culebra , Mona , Desecheo , and Caja de Muertos . Of these five, only Culebra and Vieques are inhabited year-round. Mona, which has played a key role in maritime history, is uninhabited most of the year except for employees of
7011-555: The 3 November 2020 general elections; the ballot asked one question: "Should Puerto Rico be admitted immediately into the Union as a State ?" The results showed that 52 percent of Puerto Rico voters answered yes. In the United States in the early 2020s, the Puerto Rico Status Act was being worked on by Congress, and H.R. 8393 passed the House in 2022- though it has not passed the Senate; this bill would support PR making
7134-665: The American continents. Realizing that it was in danger of losing its two remaining Caribbean territories, the Spanish Crown revived the Royal Decree of Graces of 1815 . The decree was printed in Spanish, English and French in order to attract Europeans, with the hope that the independence movements would lose their popularity and strength with the arrival of new settlers. Free land was offered to those who wanted to populate
7257-863: The Atlantic, is located about 71 mi (114 km) north of Puerto Rico at the boundary between the Caribbean and North American plates. It is 170 mi (270 km) long. At its deepest point, named the Milwaukee Deep , it is almost 27,600 ft (8,400 m) deep. The Mona Canyon , located in the Mona Passage between Puerto Rico and the Dominican Republic, is another prominent oceanic landform with steep walls measuring between 1.25 and 2.17 miles (2.01 and 3.49 km) in height from bottom to top. The climate of Puerto Rico in
7380-520: The Baptist , while the capital city was named Ciudad de Puerto Rico ("Rich Port City"). Eventually traders and other maritime visitors came to refer to the entire island as Puerto Rico, while San Juan became the name used for the main trading/shipping port and the capital city. The island's name was changed to Porto Rico by the United States after the Treaty of Paris of 1898 . The anglicized name
7503-572: The Caribbean Sea and North Atlantic Ocean. On average, a quarter of its annual rainfall is contributed from tropical cyclones , which are more prevalent during periods of La Niña than El Niño . A cyclone of tropical storm strength passes near Puerto Rico, on average, every five years. A hurricane passes in the vicinity of the island, on average, every seven years. Since 1851, the Lake Okeechobee Hurricane (also known as
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#17327874126877626-414: The Cordillera Central create a rain shadow and are the main cause of the variations in the temperature and rainfall that occur over very short distances. The mountains can also cause wide variation in local wind speed and direction due to their sheltering and channeling effects, adding to the climatic variation. Daily temperature changes seasonally are quite small in the lowlands and coastal areas. Between
7749-511: The FD&C Act. OCI Special Agents often come from other criminal investigations backgrounds, and frequently work closely with the Federal Bureau of Investigation , Assistant Attorney General , and even Interpol . OCI receives cases from a variety of sources—including ORA, local agencies, and the FBI, and works with ORA Investigators to help develop the technical and science-based aspects of
7872-633: The FDA exercises differ from one category to the next. Furthermore, legislation had granted the FDA a variety of means to address violations of standards for a given substance category. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA is responsible for ensuring that manufacturers and distributors of dietary supplements and dietary ingredients meet the current requirements. These manufacturers and distributors are not allowed to advertise their products in an adulterated way, and they are responsible for evaluating
7995-724: The FDA has had employees and facilities on 130 acres (53 hectares) of the White Oak Federal Research Center in the White Oak area of Silver Spring, Maryland . In 2001, the General Services Administration (GSA) began new construction on the campus to consolidate the FDA's 25 existing operations in the Washington metropolitan area , its headquarters in Rockville , and several fragmented office buildings. The first building,
8118-636: The FDA released a statement regarding new guidelines to help food and drug manufacturers "implement protections against potential attacks on the U.S. food supply". One of the guidelines includes the Intentional Adulteration (IA) rule, which requires strategies and procedures by the food industry to reduce the risk of compromise in facilities and processes that are significantly vulnerable. The FDA also uses tactics of regulatory shaming, mainly through online publication of non-compliance, warning letters, and "shaming lists." Regulation by shaming harnesses firms' sensitivity to reputational damage. For example, in 2018,
8241-435: The FDA's drug review budget Emergency Use Authorization (EUA) is a mechanism that was created to facilitate the availability and use of medical countermeasures, including vaccines and personal protective equipment, during public health emergencies such as the Zika virus epidemic, the Ebola virus epidemic and the COVID-19 pandemic. The programs for safety regulation vary widely by the type of product, its potential risks, and
8364-807: The Food and Drug Administration is governed by various statutes enacted by the United States Congress and interpreted by the FDA. Pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling of both the composition and the health benefits of foods. The FDA subdivides substances that it regulates as food into various categories—including foods, food additives , added substances (human-made substances that are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements . Dietary supplements or dietary ingredients include vitamins, minerals, herbs, amino acids , and enzymes . Specific standards
8487-404: The Life Sciences Laboratory, was dedicated and opened with 104 employees in December 2003. As of December 2018, the FDA campus has a population of 10,987 employees housed in approximately 3,800,000 square feet (350,000 square metres) of space, divided into ten offices and four laboratory buildings. The campus houses the Office of the Commissioner (OC), the Office of Regulatory Affairs (ORA),
8610-419: The PPD and PNP usually hold about 47% of the vote each while the PIP holds about 5%. After 2007, other parties emerged on the island. The first, the Puerto Ricans for Puerto Rico Party was registered that same year. The party claims that it seeks to address the islands' problems from a status-neutral platform. But it ceased to remain as a registered party when it failed to obtain the required number of votes in
8733-401: The Puerto Rican broad-winged hawk ( Buteo platypterus brunnescens ) and the elfin woods warbler ( Setophaga angelae ). The Northern Karst country of Puerto Rico is also home to one of the remaining rainforest tracts in the island, with the Río Abajo State Forest being the first focus for the reintroduction of the highly endangered Puerto Rican parrot outside of the Sierra de Luquillo. In
8856-473: The Puerto Rican people to exercise fully their inalienable right to self-determination and independence. In November 2012, a two-question referendum took place, simultaneous with the general elections. The first question, voted on in August, asked voters whether they wanted to maintain the current status under the territorial clause of the U.S. Constitution. 54% voted against the status quo, effectively approving
8979-646: The San Felipe Segundo hurricane in Puerto Rico) of September 1928 is the only hurricane to make landfall as a Category 5 hurricane. In 2017, Puerto Rico was affected by Category 5 Hurricane Irma and Category 4 Hurricane Maria , causing widespread and devastating impacts , particularly to the electric grid. Puerto Rico is home to three terrestrial ecoregions: Puerto Rican moist forests , Puerto Rican dry forests , and Greater Antilles mangroves . Puerto Rico has two biosphere reserves recognized by
9102-450: The U.S. Constitution . Laws enacted at the federal level in the U.S. apply to Puerto Rico as well, regardless of its political status. Their residents do not have voting representation in the U.S. Congress . Puerto Rico lacks "the full sovereignty of an independent nation", for example, the power to manage its "external relations with other nations", which is held by the U.S. federal government. The U.S. Supreme Court has indicated that once
9225-699: The U.S. Constitution has been extended to an area (by Congress or the courts), its coverage is irrevocable. To hold that the political branches may switch the Constitution on or off at will would lead to a regime in which they, not this Court, say "what the law is". Puerto Ricans "were collectively made U.S. citizens" in 1917 as a result of the Jones–Shafroth Act . U.S. citizens residing in Puerto Rico cannot vote in U.S. presidential elections, though both major parties, Republican and Democratic, hold primary elections in Puerto Rico to choose delegates to vote on
9348-472: The U.S. is the subject of ongoing debate in Puerto Rico, the U.S. Congress, and the United Nations . Specifically, the basic question is whether Puerto Rico should remain an unincorporated territory of the U.S., become a U.S. state, or become an independent country. Constitutionally, Puerto Rico is subject to the plenary powers of the U.S. Congress under the territorial clause of Article IV of
9471-488: The United States are generic brands. In 1989, a major scandal erupted involving the procedures used by the FDA to approve generic drugs for sale to the public. Charges of corruption in generic drug approval first emerged in 1988 during the course of an extensive congressional investigation into the FDA. The oversight subcommittee of the United States House Energy and Commerce Committee resulted from
9594-460: The Valiant Lord". The terms boricua , borinqueño , and borincano are commonly used to identify someone of Puerto Rican heritage, and derive from Borikén and Borinquen respectively. The island is also popularly known in Spanish as La Isla del Encanto , meaning "the island of enchantment". Columbus named the island San Juan Bautista , in honor of Saint John
9717-784: The agency published an online "black list", in which it named dozens of branded drug companies that are supposedly using unlawful or unethical means to attempt to impede competition from generic drug companies. The FDA frequently works with other federal agencies, including the Department of Agriculture , the Drug Enforcement Administration , Customs and Border Protection , and the Consumer Product Safety Commission . They also often work with local and state government agencies in performing regulatory inspections and enforcement actions. The regulation of food and dietary supplements by
9840-468: The authority to require certain technical reports from the manufacturers or importers of regulated products, to require that radiation-emitting products meet mandatory safety performance standards, to declare regulated products defective, and to order the recall of defective or noncompliant products. CDRH also conducts limited amounts of direct product testing. Clearance requests are required for medical devices that prove they are "substantially equivalent" to
9963-800: The biologic. After approval, annual reports, reports on adverse events, manufacturing changes, and labeling changes must be submitted. Food and Drug Administration The United States Food and Drug Administration ( FDA or US FDA ) is a federal agency of the Department of Health and Human Services . The FDA is responsible for protecting and promoting public health through the control and supervision of food safety , tobacco products, caffeine products, dietary supplements , prescription and over-the-counter pharmaceutical drugs (medications), vaccines , biopharmaceuticals , blood transfusions , medical devices , electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products . The FDA's primary focus
10086-478: The case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a physical examination or take a physical sample of the product. The Office of Regulatory Affairs is divided into five regions, which are further divided into 20 districts. The districts are based roughly on the geographic divisions of the Federal court system . Each district comprises a main district office and
10209-531: The clinical investigations are completed. If the Form 356h is missing information, the FDA will reply within 74 days. A BLA asserts that the product is "safe, pure, and potent", the manufacturing facilities are inspectable, and each package of the product bears the license number. Statutory standards for BLA approval are largely the same as those for New Drug Application approval. According to 21 CFR 600.3 , FDA interprets "potency" to include effectiveness of
10332-675: The commissioner's power to vote in the Committee of the Whole , but the commissioner can vote in committee. Puerto Rican elections are governed by the Federal Election Commission and the State Elections Commission of Puerto Rico . Residents of Puerto Rico, including other U.S. citizens, cannot vote in U.S. presidential elections, but can vote in primaries . Puerto Ricans who become residents of
10455-511: The contexts varying from household pets to human sperm donated for use in assisted reproduction . The FDA is led by the commissioner of Food and Drugs , appointed by the President with the advice and consent of the Senate . The commissioner reports to the secretary of health and human services . Robert Califf is the current commissioner as of February 17, 2022. The FDA's headquarters
10578-469: The drug in question is a prescription drug or an over-the-counter (OTC) drug. The FDA oversees the advertising of prescription drugs, while the FTC regulates the advertising of OTC drugs. The term off-label refers to the practice of prescribing a drug for a different purpose than what the FDA approved. Due to this approval requirement, manufacturers were prohibited from advertising COVID-19 vaccines during
10701-416: The drug is used safely. For example, thalidomide can cause birth defects, but has uses that outweigh the risks if men and women taking the drugs do not conceive a child; a REMS program for thalidomide mandates an auditable process to ensure that people taking the drug take action to avoid pregnancy; many opioid drugs have REMS programs to avoid addiction and diversion of drugs. The drug isotretinoin has
10824-468: The dry and wet seasons, there is a temperature change of around 6 °F (3.3 °C). This change is due mainly to the warm waters of the tropical Atlantic Ocean , which significantly modify cooler air moving in from the north and northwest. Coastal water temperatures during the year are about 75 °F (24 °C) in February and 85 °F (29 °C) in August. The highest temperature ever recorded
10947-696: The early 1990s, the U.S. Securities and Exchange Commission filed securities fraud charges against the Bolar Pharmaceutical Company, a major generic manufacturer based in Long Island, New York. Over-the-counter (OTC) are drugs like aspirin that do not require a doctor's prescription. The FDA has a list of approximately 800 such approved ingredients that are combined in various ways to create more than 100,000 OTC drug products. Many OTC drug ingredients had been previously approved prescription drugs now deemed safe enough for use without
11070-648: The federal agency resulted in racketeering and in violations of antitrust law . "The order in which new generic drugs were approved was set by the FDA employees even before drug manufacturers submitted applications" and, according to Mylan, this illegal procedure was followed to give preferential treatment to certain companies. During the summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancato, Walter Kletch) pleaded guilty to criminal charges of accepting bribes from generic drugs makers, and two companies ( Par Pharmaceutical and its subsidiary Quad Pharmaceuticals) pleaded guilty to giving bribes. Furthermore, it
11193-399: The federal government, Puerto Rico-based corporations that intend to send funds to the U.S., and some others, such as Puerto Rican residents that are members of the U.S. military, and Puerto Rico residents who earned income from sources outside Puerto Rico also pay federal income taxes. In addition, because the cutoff point for income taxation is lower than that of the U.S. IRS code, and because
11316-436: The federal government. It helps support "partner" agencies and organisations prepare for public health emergencies that could require MCMs. The Center for Drug Evaluation and Research uses different requirements for the three main drug product types: new drugs, generic drugs, and over-the-counter drugs. A drug is considered "new" if it is made by a different manufacturer, uses different excipients or inactive ingredients,
11439-415: The government to move rapidly to provide for the general welfare contributed to political activism by opponents and eventually to the rise of the Puerto Rican Nationalist Party . On 7 January 2020, the country experienced its largest earthquake since 1918, estimated at magnitude 6.4. Economic losses were estimated to be more than $ 3.1 billion. The Puerto Rico Trench , the largest and deepest trench in
11562-514: The island. It is also home to 50 bird species, including the critically endangered Puerto Rican amazon . In addition to El Yunque National Forest, the Puerto Rican moist forest ecoregion is represented by protected areas such as the Maricao and Toro Negro state forests . These areas are home to endangered endemic species such as the Puerto Rican boa ( Chilabothrus inornatus ), the Puerto Rican sharp-shinned hawk ( Accipiter striatus venator ),
11685-518: The islands on the condition that they swear their loyalty to the Spanish Crown and allegiance to the Catholic Church . In 1898, during the Spanish–American War , Puerto Rico was invaded and subsequently became a possession of the U.S. The first years of the 20th century were marked by the struggle to obtain greater democratic rights from the U.S. The Foraker Act of 1900 established a civil government, ending rule by American generals and
11808-555: The issuance of enforcement letters to pharmaceutical manufacturers. Advertising and promotion for over-the-counter drugs is regulated by the Federal Trade Commission . The FDA also implements regulatory oversight through engagement with third-party enforcer-firms. It expects pharmaceutical companies to ensure that third-party suppliers and labs comply with the agency's health and safety guidelines . The drug advertising regulation contains two broad requirements: (1)
11931-597: The last election held in November 2020 . The judicial branch is headed by the chief justice of the Supreme Court of Puerto Rico , currently Maite Oronoz Rodríguez . Members of the judiciary are appointed by the governor with the advice and consent of the Senate. Puerto Rico is represented in the U.S. Congress by a nonvoting delegate to the House of Representatives, the resident commissioner , currently Jenniffer González . Current congressional rules have removed
12054-561: The late 19th century, a distinct Puerto Rican identity began to emerge, centered around a fusion of European , African , and indigenous elements. In 1898, following the Spanish–American War , Puerto Rico was acquired by the United States . Puerto Ricans have been U.S. citizens since 1917 and can move freely between the archipelago and the mainland . However, residents of Puerto Rico are disenfranchised from federal elections and generally do not pay federal income tax . In common with four other territories , Puerto Rico sends
12177-588: The most dangerous geologic hazards in the island and in the northeastern Caribbean. The 1918 San Fermín earthquake occurred on 11 October , 1918 and had an estimated magnitude of 7.5 on the Richter scale . It originated off the coast of Aguadilla , several kilometers off the northern coast, and was accompanied by a tsunami . It caused extensive property damage and widespread losses, damaging infrastructure, especially bridges. It resulted in an estimated 116 deaths and $ 4 million in property damage. The failure of
12300-555: The next 400 years. The decline of the indigenous population , followed by an influx of Spanish settlers, primarily from the Canary Islands and Andalusia , and African slaves vastly changed the cultural and demographic landscape of the archipelago. Within the Spanish Empire , Puerto Rico played a secondary but strategically significant role compared to larger and wealthier colonies like Peru and New Spain . By
12423-445: The parties' presidential candidates. Since Puerto Rico is an unincorporated territory and not a U.S. state, the U.S. Constitution does not fully enfranchise U.S. citizens residing in Puerto Rico. Only fundamental rights under the American federal constitution and adjudications are applied to Puerto Ricans. Various other U.S. Supreme Court decisions have held which rights apply in Puerto Rico and which ones do not. Puerto Ricans have
12546-476: The per-capita income in Puerto Rico is much lower than the average per-capita income on the mainland, more Puerto Rico residents pay income taxes to the local taxation authority than if the IRS code were applied to the island. This occurs because "the Commonwealth of Puerto Rico government has a wider set of responsibilities than do U.S. State and local governments." In 2009, Puerto Rico paid $ 3.742 billion into
12669-533: The period in which they had only been approved under Emergency Use Authorization . After NDA approval, the sponsor must then review and report to the FDA every single patient adverse drug experience it learns of. They must report unexpected serious and fatal adverse drug events within 15 days, and other events on a quarterly basis. The FDA also receives directly adverse drug event reports through its MedWatch program. These reports are called "spontaneous reports" because reporting by consumers and health professionals
12792-507: The population applying for assistance after the storms. See also Effects of Hurricane Maria in Puerto Rico It is thought that a combination of the debt crisis and two major hurricanes in the late 2010s, caused further departures from the island. Overall the population has decreased by about half a million in the 21st century, with many seeking better opportunities on the mainland. Puerto Rico held its statehood referendum during
12915-422: The predicate devices already on the market. Approved requests are for items that are new or substantially different and need to demonstrate "safety and efficacy", for example they may be inspected for safety in case of new toxic hazards. Both aspects need to be proved or provided by the submitter to ensure proper procedures are followed. Cosmetics are regulated by the Center for Food Safety and Applied Nutrition ,
13038-580: The regulated industries. Rather, OCI agents pursue and develop cases when individuals and companies commit criminal actions, such as fraudulent claims or knowingly and willfully shipping known adulterated goods in interstate commerce. In many cases, OCI pursues cases involving violations of Title 18 of the United States Code (e.g., conspiracy, false statements, wire fraud, mail fraud), in addition to prohibited acts as defined in Chapter III of
13161-470: The regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy, and safety—yet FDA regulation of cosmetics focuses primarily on labeling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections. Inspection observations are documented on Form 483 . In June 2018,
13284-448: The safety and labeling of their product. The FDA has a "Dietary Supplement Ingredient Advisory List" that includes ingredients that sometimes appear on dietary supplements but need further evaluation. An ingredient is added to this list when it is excluded from use in a dietary supplement, does not appear to be an approved food additive or recognized as safe, and/or is subjected to the requirement for pre-market notification without having
13407-458: The same branch of the FDA that regulates food. Cosmetic products are not, in general, subject to premarket approval by the FDA unless they make "structure or function claims" that make them into drugs (see Cosmeceutical ). However, all color additives must be specifically FDA approved before manufacturers can include them in cosmetic products sold in the U.S. The FDA regulates cosmetics labeling, and cosmetics that have not been safety tested must bear
13530-418: The second question to be voted on in November. The second question posed three alternate status options: statehood, independence, or free association . 61.16% voted for statehood, 33.34% for a sovereign free-associated state, and 5.49% for independence. In 2016, President Barack Obama signed into law H.R. 5278: PROMESA , establishing a Control Board over the Puerto Rican government. This board will have
13653-670: The seven year-long bioluminescent bays in the Caribbean: Laguna Grande in Fajardo , La Parguera in Lajas and Puerto Mosquito in Vieques . These are unique bodies of water surrounded by mangroves that are inhabited by the dinoflagellate Pyrodinium bahamense . However, tourism, pollution, and hurricanes have highly threatened these unique ecosystems. Puerto Rico has a republican form of government based on
13776-706: The size of Hispaniola and 8% of the size of Cuba, the largest of the Greater Antilles. The topography of the island is mostly mountainous with large flat areas in the northern and southern coasts. The main mountain range that crosses the island from east to west is called the Cordillera Central (also known as the Central Mountain Range in English). The highest elevation in Puerto Rico, Cerro de Punta 4,390 feet (1,340 m),
13899-465: The south, since the south receives less rain than the central and northern regions. Puerto Rico is composed of Cretaceous to Eocene volcanic and plutonic rocks, overlain by younger Oligocene and more recent carbonates and other sedimentary rocks . Most of the caverns and karst topography on the island occurs in the northern region. The oldest rocks are approximately 190 million years old ( Jurassic ) and are located at Sierra Bermeja in
14022-541: The southwest part of the island. They may represent part of the oceanic crust and are believed to come from the Pacific Ocean realm. Puerto Rico lies at the boundary between the Caribbean and North American Plates and is being deformed by the tectonic stresses caused by their interaction. These stresses may cause earthquakes and tsunamis . These seismic events, along with landslides , represent some of
14145-614: The southwest, the Guánica State Forest and Biosphere Reserve contain over 600 uncommon species of plants and animals, including 48 endangered species and 16 that are endemic to Puerto Rico, and is considered a prime example of the Puerto Rican dry forest ecoregion and the best-preserved dry forest in the Caribbean. Other protected dry forests in Puerto Rico can be formed within the Caribbean Islands National Wildlife Refuge complex at
14268-618: The way for the drafting of Puerto Rico's Constitution and its approval by Congress and Puerto Rican voters in 1952. Puerto Rico is one of five territories with less representation in the Federal government, along with the Federal District. In 2009, the United Nations Special Committee on Decolonization approved a draft resolution calling on the U.S. government to expedite a process that would allow
14391-465: Was 110 °F (43 °C) at Arecibo , while the lowest temperature ever recorded was 40 °F (4 °C) in the mountains at Adjuntas , Aibonito , and Corozal . The average yearly precipitation is 66 in (1,676 mm). Climate change in Puerto Rico has had a large impact on the ecosystems and landscapes. Puerto Rico experiences the Atlantic hurricane season , similar to the rest of
14514-601: Was boycotted by some political opponents of it. (see 2017 Puerto Rican status referendum ) In 2017, Puerto Rico suffered back-to-back large hurricanes: the Category 5 Hurricane Irma (September 7, 2017) and the Category 4 Hurricane Maria (September 20, 2017). The storms caused an extreme amount of damage to the island, causing the following effects: all power was knocked out, 95% cell service, 43% of waste water treatment plants, 40 thousand land slides, 97% of roads blocked, 28% of health facilities damaged, leading to over 90% of
14637-533: Was discovered that several manufacturers had falsified data submitted in seeking FDA authorization to market certain generic drugs. Vitarine Pharmaceuticals of New York, which sought approval of a generic version of the drug Dyazide , a medication for high blood pressure, submitted Dyazide, rather than its generic version, for the FDA tests. In April 1989, the FDA investigated 11 manufacturers for irregularities; and later brought that number up to 13. Dozens of drugs were eventually suspended or recalled by manufacturers. In
14760-543: Was established by the 1902 Biologics Control Act , with additional authority established by the 1944 Public Health Service Act . Along with these Acts, the Federal Food, Drug, and Cosmetic Act applies to all biologic products, as well. Originally, the entity responsible for regulation of biological products resided under the National Institutes of Health ; this authority was transferred to the FDA in 1972. The Center for Devices and Radiological Health (CDRH)
14883-405: Was settled by a succession of Amerindian peoples beginning 2,000 to 4,000 years ago; these included the Ortoiroid , Saladoid , and Taíno . It was claimed by Spain following the arrival of Christopher Columbus in 1493 and subsequently colonized by Juan Ponce de León in 1508. Puerto Rico was contested by other European powers into the 18th century but remained a Spanish possession for
15006-457: Was suggested by its architect Luis Muñoz Marín and adopted by a constitutional assembly on July 25 1952. Some authorities have called it a euphemism and have charged that the official name in English of "Commonwealth" constitutes a fig leaf , i.e., associated with the covering up of an act that is actually embarrassing or distasteful with something of innocuous appearance. Puerto Rico remains
15129-570: Was used by the U.S. government and private enterprises (also Porto in Italian, French, and Portuguese). The name was changed back to Puerto Rico in 1931 by a joint resolution in Congress introduced by Félix Córdova Dávila . The official name of the entity in Spanish is Estado Libre Asociado de Puerto Rico ("Free Associated State of Puerto Rico"), while its official English name is Commonwealth of Puerto Rico . The Spanish official name
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