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85-747: The construction of Duke-NUS Medical School's primary facility, the Khoo Teck Puat Building, started in December 2006. In May 2009, the School shifted from its first campus at Jalan Bukit Merah into the Outram campus of Singapore General Hospital , next to the College of Medicine Building . The 13-storey green-certified building was officially inaugurated by Prime Minister of Singapore Lee Hsien Loong on 28 September 2009. On 30 November 2010,

170-658: A Doctor of Philosophy (PhD) programmes in Integrated Biology and Medicine, Clinical and Translational Sciences, as well as Quantitative Biology and Medicine. Graduates from the IBM track are conferred PhD degrees jointly award by Duke University and the National University of Singapore, while graduates from the other two tracks receive their PhD degrees from the National University of Singapore. Duke-NUS also offers an MD-PhD programme, where students complete

255-743: 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

340-490: A postgraduate medical institute. On 1 April 1989, the hospital was restructured, in an effort to modernise the organisation of the hospital, due to rapidly developing changes in healthcare services and patient expectations for better service. As a restructured hospital, the Singapore General Hospital is still 100 per cent government-owned and is a not-for-profit institution . More than 60 per cent of

425-460: 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

510-425: 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

595-767: 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

680-527: 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

765-426: 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

850-432: 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

935-478: A new 12-storey specialised building that will be four times larger than the hospital's existing A&E facilities. The building will be connected to its specialty centres as well as the Outram Community Hospital. It is expected to begin operations in 2023. The Singapore General Hospital Museum is a repository of artefacts and records, where visitors can trace the long and rich history of

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1020-538: A new Proton Therapy Centre, which allows the NCCS to engage in proton therapy to treat cancer in their patients. It is the first and only hospital in the region to have such facilities. The National Heart Centre Singapore (NHCS) is a specialist medical centre and a regional referral centre for cardiovascular diseases . Established in 1994 as the Singapore Heart Centre in the Singapore General Hospital,

1105-504: 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

1190-651: 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

1275-601: A part of SGH or SingHealth, it acts as a supplementary facility to keep up with the rising demand of public dental services in the country. A new and larger National Dental Centre Singapore is also currently being constructed, which is expected to more than double its capacity by 2025. These include expanding the Geriatric Special Care Dentistry Clinic, to meet the needs of the older generation in Singapore. The Elective Care Centre (ECC)

1360-498: 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

1445-523: 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

1530-440: 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

1615-612: A team led by Professor Wang Linfa, from Duke-NUS' Emerging Infectious Diseases programme, the kit was also the first of its kind to receive emergency authorisation from the United States Food and Drug Administration (FDA). A precursor of the test was also used to detect Singapore's largest coronavirus infection cluster at the Grace Assembly of God Church. Known as SwabBot, the robot developed by Rena Dharmawan and her team carries out nasal swabbing, helping to address

1700-561: 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

1785-401: 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

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1870-460: Is a facility that will focus on non-emergency surgeries, which aims to offload resources at the main hospital. It is currently under construction, and it is expected to begin operations in 2026. United States 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

1955-651: 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

2040-503: Is active in research as well as training activities, especially focusing on the professional education of dentists. NDCS has been under the management of Singapore Health Services Pte Ltd since 2002. In 2019, the National University Centre for Oral Health, Singapore (NUCOHS) started operations at one-north , becoming the second national facility in Singapore to offer specialised dental health services. Although not

2125-809: Is an academic health science centre and tertiary referral hospital in Singapore . It is located next to the Bukit Merah and Chinatown districts of the Central Region , close to the Outram Community Hospital (OCH), which functions as a supplementary community and rehabilitation hospital to SGH for newly discharged patients. There is also the Outram Polyclinic to complement outpatient care . All of these institutions are operated by SingHealth , which comes under

2210-564: 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

2295-745: 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,

2380-472: 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

2465-449: 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

2550-741: 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

2635-702: 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

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2720-451: 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

2805-685: 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

2890-643: 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

2975-606: 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)

3060-496: The 186-bed specialty centre for cardiovascular disease in Singapore offers treatments from preventive to rehabilitative cardiac services. The National Dental Centre Singapore (NDCS) is a facility in Singapore for specialist oral healthcare services. It commenced operations on 1 March 1997 and claims to offer the largest concentration of specialist expertise in a single facility. Its specialist teams attend to over 700 patients daily, including walk-in patients and those being referred to

3145-406: 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

3230-499: The AMC harnesses the collective strengths of Duke-NUS' medical education and research capabilities, and SingHealth's clinical expertise to bring about improved healthcare and patient outcomes. Some of the centres launched under this partnership include: Graduates are awarded degrees from both Duke University and the National University of Singapore. Academic clinical programmes were created for 15 clinical specialties, harnessing

3315-548: The Elective Care Centre Singapore (ECC), is currently under construction and it is expected to be completed in 2025. SGH has been considered as being one of the best hospitals in the world, being consistently ranked in the top 10 by Newsweek , reaching its highest of 3rd in 2019. Subsequently, it is the highest ranked hospital in Asia, drawing in patients from around the region, with SGH performing near

3400-511: 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

3485-633: 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

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3570-724: 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,

3655-713: 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,

3740-594: 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

3825-881: 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

3910-647: 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), 

3995-418: The School's research and innovations made in the fight against COVID-19, Duke-NUS launched a book titled Duke-NUS COVID Stories , along with a microsite. Senior management at Duke-NUS Medical School includes the following. 1°16′52″N 103°50′03″E  /  1.28117°N 103.83416°E  / 1.28117; 103.83416 Singapore General Hospital Singapore General Hospital ( SGH )

4080-435: The Singapore General Hospital. It is also a place where one can learn about the development of medical specialties and medical education in Singapore, presented with the aid of audio-visual and multimedia technology . The SGH Museum was officially opened by President SR Nathan on 20 May 2005. The museum adopts a thematic approach in presenting the hospital's long history, where visitors get not just an insight into

4165-488: 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

4250-784: 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

4335-468: 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

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4420-571: The beds are allocated for subsidised patients, giving them access to an internationally established standard of affordable healthcare . On 31 March 2000, a major reorganisation of the public sector healthcare services was initiated by the Ministry of Health (MOH). Since then, the Singapore General Hospital came under the management of Singapore Health Services or SingHealth. In 2018, SGH announced that it will be expanding its accident and emergency (A&E) facilities, which include constructing

4505-478: 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

4590-442: The causes to find treatments to eye conditions such as myopia and glaucoma . SNEC's facilities includes 50 consultation suites, 9 operating theatres, research facilities, offices and a library in two adjoining buildings. The National Cancer Centre Singapore (NCCS) is the country's national specialty centre for the diagnosis, research and treatment of cancer . The centre has Singapore's largest concentration of oncologists. It

4675-463: The centre is a teaching institution for post-graduate cancer education that trains and offers fellowships for many local and overseas doctors, nurses, para-medical professionals and researchers. On 2 June 2017, construction for an additional building to the NCCS began, which include more facilities to cater to increased patients' access to cancer treatment as well as the specialty centre's capacity. Slated to begin operations in 2022, it will also include

4760-720: The centre. The centre is equipped with 92-chair facility and a day surgery suite. The centre has three specialist clinical departments, being the Departments of Oral and Maxillofacial Surgery , Orthodontics and Restorative Dentistry , which attend to a wide range of oral conditions. In addition, Department of Restorative Dentistry also has sub-units in Endodontics , Paediatric Dentistry, Periodontics and Prosthodontics . Sub-speciality multidisciplinary services are available through NDCS's Centres for Corrective Jaw Surgery, Maxillofacial Rehabilitation and Facial Pain. The centre

4845-707: The class with a test, and then proceed to discuss the test questions and other open-ended questions in a small group setting. The faculty act as facilitators for student discussions, moving away from traditional pedagogical teaching. Prospective students are required to take the Medical College Admission Test (MCAT) or the Graduate Medical School Admissions Test (GMAT). Applicants are also evaluated based on their academic performance, research experience, and evidence of leadership capabilities. Duke-NUS offers

4930-511: 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

5015-676: The course of study and fulfill all requirements are awarded a joint MD degree from Duke University and the National University of Singapore. The Duke-NUS curriculum is similar to that of the Duke University School of Medicine, consisting of four years: the first year is for pre-clerkship, the second year for clerkship, the third year for research, and the fourth year for advanced clinical rotations. Duke-NUS employs an extensive team-based learning method called TeamLEAD (Learn, Engage, Apply, Develop). Students prepare for classes with pre-reading materials and recorded lectures. They begin

5100-469: 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

5185-416: 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

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5270-696: 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

5355-488: The expertise of each discipline across SingHealth and Duke-NUS for cooperation in clinical care, education and research. cPass is a COVID-19 test kit that Duke-NUS co-developed with biotech company GenScript Biotech Corporation and the Agency for Science, Technology and Research 's (A*Star) Diagnostics Development Hub (DxD Hub), capable of checking for signs of a COVID-19 infection in individuals within an hour. Developed by

5440-648: 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

5525-436: 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,

5610-463: The following: one year of basic science coursework, one year of clinical rotations, four years of research work in Singapore or the United States, and a final year of clinical rotations. Signature research programmes at Duke-NUS focus on the following areas. Duke-NUS hosts several research and medical centres. The SingHealth Duke-NUS Academic Medical Centre (AMC) was established by SingHealth and Duke-NUS. Through this partnership in academic medicine,

5695-649: The fourth phase of the Duke-NUS collaboration agreement was signed by the presidents of Duke-NUS' two parent universities at a ceremony held in Durham, North Carolina , extending the partnership for another five years. Below are graduate programmes that are offered at Duke-NUS Medical School. Duke-NUS' Doctor of Medicine (MD) programme is a four-year programme based on the Duke University School of Medicine curriculum. Students who successfully complete

5780-445: The heart centre took over the hospital's cardiac services and set up a cardiology laboratory in 1995. It was renamed in 1998. In 2014, NHCS completed its move to a new purpose-built building at 5 Hospital Drive. The new building not only includes facilities for outpatient clinics and non-invasive testing, but also has operating theatres and an invasive cardiac catheterisation laboratory. With over 9,000 inpatient admissions every year,

5865-643: The highest number of transplants in the country, including both solid hematologic and organ transplantation . The Singapore General Hospital was established in 1821, when the first General Hospital was located in the cantonment for British troops near the Singapore River . It later shifted to Pearl Banks apartment and then to the Kandang Kerbau district, before finally settling at Sepoy Lines along Outram Road in 1882. The modern history of Singapore General Hospital began on 29 March 1926, with

5950-555: 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)

6035-555: The limitations of manual COVID-19 swabbing as well as to standardise the consistency of swabs taken. Co-developed by SingHealth Duke-NUS Academic Medical Centre and the National University of Singapore researchers, this saliva-based COVID-19 Antigen Rapid Test (ART) technology uses a proprietary on-kit amplification technique, enabling detection of the SARS-CoV-2 virus with sensitivity close to that of laboratory-based polymerase chain reaction (PCR) tests, in 15 minutes. To chronicle

6120-665: The opening of 800 beds in the Bowyer, Stanley and Norris Blocks. Today, only the Bowyer Block with its historically distinctive clock tower remains. The Bowyer Block is now home to the Singapore General Hospital Museum or the SGH Museum. In 1981, the hospital was rebuilt, with its current 8-block complex housing in-patient wards, ambulatory and support services, research laboratories and

6205-533: 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

6290-422: 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 ,

6375-882: The principal teaching hospital for the Duke–NUS Medical School , which is affiliated with the National University of Singapore . Its campus includes four national speciality centres, namely the Singapore National Eye Centre (SNEC), the National Heart Centre Singapore (NHCS), the National Cancer Centre Singapore (NCCS), and the National Dental Centre Singapore (NDCS). A fifth speciality centre,

6460-450: The purview of the Ministry of Health (MOH). It is the largest and oldest hospital in Singapore and functions as the country's national hospital. The foundation of its first building was laid in 1821, before its first major expansion in 1926. Subsequent expansions as well as renovations were also made in the following decades. SGH is the flagship hospital of SingHealth, the country's largest group of public healthcare institutions and

6545-580: 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

6630-470: 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,

6715-448: 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

6800-458: 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

6885-639: The significant developments of the hospital through the years, but also an understanding of the impact these incidents have on the people and the community . Singapore National Eye Centre (SNEC) is a specialty centre for ophthalmological services and is the largest ophthalmology specialist centre in Singapore. It was founded in 1990 to lead and organise specialised ophthalmological services with special emphasis on research and education. Since its inauguration, SNEC has averaged an annual workload of 14,000 major eye surgeries and 13,000 laser procedures. The SNEC also actively participates in clinical trials and researches

6970-524: The strategic collaboration between Duke and NUS was extended by a further five years. On 2 June 2016, the stakeholders extended this through another five-year agreement. During this third phase of the partnership, SingHealth came onboard as Duke-NUS' academic medicine partner. Together, Duke-NUS and SingHealth transformed the campus at Outram into the SingHealth Duke-NUS Academic Medical Centre. On 13 October 2022,

7055-533: 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

7140-543: 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)

7225-474: Was originally established in 1993 as a unit of Singapore General Hospital, and subsequently became an autonomous institution of SingHealth. The centre's founding director is Professor Soo Khee Chee. NCCS provides a range of medical, educational and research activities within a single institution; and practices a multi-disciplinary approach to diagnosis and treatment. It is Southeast Asia's only full multi-disciplinary sub-specialist centre for cancer. In addition,

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