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U.S.F.D.A. :

U.S.F.D.A. GADADE DIPAK Asst. Professor, Shri Bhagwan college of Pharmacy, A urangabad


U.S. FDA It functions within U.S. Dept of Health and Human services FDA was created to administer the Federal Food, Drug and cosmetic Acts and their various amendments It has various divisions which regulates different types of products Most important are CDER and CBER 2

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What does the FDA regulate?:

What does the FDA regulate? Foods, including: dietary supplements bottled water food additives infant formulas other food products (although the U.S. Department of Agriculture plays a lead role in regulating aspects of some meat, poultry, and egg products ) Drugs, including: prescription drugs (both brand-name and generic) non-prescription (over-the-counter) drugs Biologics , including: vaccines blood and blood products cellular and gene therapy products tissue and tissue products allergenics Medical Devices, including: simple items like tongue depressors and bedpans complex technologies such as heart pacemakers dental devices surgical implants and prosthetics 5

What does the FDA regulate?:

What does the FDA regulate? Electronic Products that give off radiation, including: microwave ovens x-ray equipment laser products ultrasonic therapy equipment mercury vapor lamps Sunlamps Cosmetics , including: color additives found in makeup and other personal care products skin moisturizers and cleansers nail polish and perfume Veterinary Products, including: livestock feeds pet foods veterinary drugs and devices Tobacco Products, including: cigarettes Cigarette tobacco roll-your-own tobacco smokeless tobacco 6

What does the Center for Drug Evaluation and Research do?:

What does the Center for Drug Evaluation and Research do? Center is a consumer watchdog in America's healthcare system. Evaluate new drugs before they can be sold. Review of new drug applications not only prevents quackery, but it provides doctors and patients with the information they need to use medicines wisely. It makes sure that safe and effective drugs are available to improve the health of consumers. CDER ensures that prescription and OTC drugs, both brand name and generic, work correctly and that the health benefits outweigh known risks. 7

CDER Structure:

CDER Structure Office of the Center Director Advisory Committee Staff Controlled Substance Staff Uncontrolled regulations Office of Compliance Division of Compliance Risk Management and Surveillance Division of Manufacturing and Product Quality Division of New Drugs and Labeling Compliance Division of Scientific Investigations Office of Medical Policy Office of Prescription Drug Promotion Office of New Drugs Office of Nonprescription Products Office of Oncology Drug Products Radioactive Drug Research Committee (RDRC) Program Office of Pharmaceutical Science Office of Biotechnology Products Office of Generic Drugs Office of New Drugs Quality Assessment Office of Testing and Research Division of Applied Pharmacology Research Division of Pharmaceutical Analysis Division of Product Quality Research Informatics and Computational Safety Analysis Staff (ICSAS) Office of Surveillance and Epidemiology (formerly Office of Drug Safety) Office of Translational Sciences Office of Biostatistics Office of Clinical Pharmacology Pharmacometrics Staff 8

What drugs are regulated by CDER?:

What drugs are regulated by CDER? Evaluates the benefits and risks of drugs and ensures that consumers have access Oversee the research, development, manufacture and marketing of drugs CDER regulates: Prescription Drugs Prescription medicines include any drug product that requires a doctor's authorization to purchase. Generic Drugs A generic drug is a drug product that is equivalent to brand name products in terms of quality and performance. Over-the-Counter Drugs OTC drug products are available to consumers without a doctor's prescription. 9


CDER FUNCTIONS Reviewing drugs before marketing Watching for drug problems Monitoring drug information and advertising Scientific research Protecting drug quality 10

FDA history:

FDA history " Lee Barlett , a former shirt salesman from Pittsburgh, promoted a medicine called Banbar as being effective for diabetes. Banbar was an extract of horsetail weed. The government took Barlett to court for selling a misbranded drug and even showed the death certificates of people with diabetes who had taken Banbar. But the jury ruled in Barlett's favor Pure Food and Drugs Act -1906 The law required only that drugs meet standards of strength and purity.   The burden of proof was on the government to show that a drug's labeling was false and misleading before it could be taken off the market. 11


FDA-History The Food, Drug, and Cosmetic Act of 1938 A bill was introduced in the U.S. Senate in 1933 to overhaul the 1906 drug law. But congressional action stalled. Revised legislation wasn't passed until 107 people died from a poisonous ingredient in Elixir Sulfanilamide. The S.E. Massengill Co. of Bristol, Tenn., had been marketing the product, which was the chemical relative of antifreeze now used in automobiles. 12


FDA-History The Kefauver-Harris Drug Amendments-1962 1962, news reports about how FDA Medical Officer Frances O. Kelsey, M.D., Ph.D., had kept the drug thalidomide off the U.S. market aroused public interest in drug regulation. Thalidomide had been marketed as a sleeping pill by the German firm Chemie Grunenthal , and was associated with the birth of thousands of malformed babies in Western Europe In October 1962, Congress passed the Kefauver-Harris Drug Amendments to the Federal FD&C Act. Before marketing a drug, firms now had to prove not only safety, but also provide substantial evidence of effectiveness for the product's intended use. Temple says, "That evidence had to consist of adequate and well-controlled studies, a revolutionary requirement." 13


FDA-History The Orphan Drug Act-1983 "Orphans" are drugs and other products used to treat rare diseases. People affected by rare diseases created a groundswell of support for legislation, and the Orphan Drug Act (ODA) was passed in 1983. It allowed the FDA to encourage research and development of drugs needed to treat rare diseases. Before this time, people with rare diseases were denied access to effective medication because manufacturers could rarely make a profit marketing drugs to such a small group. The ODA created financial incentives, including tax credits for the costs of clinical research and seven years of marketing exclusivity for the first sponsor of an orphan product who receives FDA approval for a particular indication. 14


FDA-History Drug Price Competition and Patent Term Restoration Act of 1984 The ANDAs make it less costly and time consuming for generics, which are often sold at lower prices than brand-name drugs, to reach the market. encourages production of generics while protecting rights of brand-name manufacturers. protections for the original drug developer in terms of patents and market exclusivities to encourage further drug development, Biowaivers Rewards a period of exclusive marketing for the first generic version of a brand-name drug to challenge a patent, thereby encouraging generic firms to challenge innovator patents. Not all medicines are eligible for generic competition because of innovator patents or exclusivities 15

FDA History:

FDA History Drugs for Life-Threatening Illnesses-1987 allows promising investigational drugs to be given to people with life-threatening diseases for which there is no alternative while the data to support marketing are being collected. 16

FDA History:

FDA History The Prescription Drug User Fee Act-1992 In exchange for the additional resources, the FDA makes a commitment to meet certain goals for review times," Woodcock says. For example, by 2002, the FDA's reviews of all marketing applications for new drugs were to be completed in 10 months. The PDUFA allowed the agency to have a 60 percent increase in staff assigned to review new drug applications. Woodcock says, "CDER has exceeded almost all of the goals set by PDUFA." 17

The Food and Drug Modernization Act of 1997:

The Food and Drug Modernization Act of 1997 Congressman  Richard Burr  and Senator  James M. Jeffords  were the chairperson sponsors of the Food and Drug Administration Regulatory Modernization Act of 1997 The U.S. legislation was signed by  Bill Clinton  on 21 November 1997, and was fully enacted by 1 April 1999, putting into law reforms begun under the  National Partnership for Reinventing Government One result of the passing of the act was a reduction in the time for the approval of new pharmaceutical drugs 18

The Food and Drug Modernization Act of 1997:

The Food and Drug Modernization Act of 1997 Modernization Act: It includes strengthening the drug safety system with three key efforts : Strengthening the science of drug safety Improving communications Improving operations and management 19

The Food and Drug Modernization Act of 1997:

The Food and Drug Modernization Act of 1997 Provisions Prescription drug user fees-reauthorization Information on Off-label Use and Drug Economics Prohibits unapproved uses of drugs and medical devices Act allows a firm to circulate peer-reviewed journal articles about an off-label indication of its product P roof of research within a certain amount of time Allow to provide economic information about their products without compromising prescribing choices Pharmacy Compounding Exemption to ensure continued availability of compounded drug products prepared by pharmacists to provide patients with individualized therapies not available commercially 20

The Food and Drug Modernization Act of 1997:

The Food and Drug Modernization Act of 1997 Risk-based Regulation of Medical Devices measures to focus its resources on medical devices that present the greatest risks to patients. post market surveillance on higher risk devices, to implement a reporting system that concentrates on a representative sample of user facilities—such as hospitals and nursing homes—that experience deaths and serious illnesses or injuries linked with the use of devices. "third party"—experts to conduct the initial review of all low-to-intermediate risk devices 21

The Food and Drug Modernization Act of 1997:

The Food and Drug Modernization Act of 1997 Food Safety and Labeling Eliminates the requirement of the FDA's premarket approval for most packaging and other substances that come in contact with food and may migrate into it the manufacturer can notify the agency of its intent to use certain food contact substances and, unless the FDA objects within 120 days, the manufacturer may proceed with the marketing of the new product. FDA can authorize health claims and nutrient content claims without reducing the statutory standard. 22

The Food and Drug Modernization Act of 1997:

The Food and Drug Modernization Act of 1997 Standards for medical products clinical investigation as the basis for product approval adequate and well-controlled studies are needed to prove the product's safety and effectiveness. 23


REFERENCES G.S. Banker, Modern pharmaceutics, 4 th ed, 2005, Marcel dekker pub, pg. no. 629-630 24

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