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U.S.FOOD AND DRUGS ADMINISTRATION Presented By: GuidedBy: Miss Devanshi H. Soni Mr. Haresh Mulani Roll No: 01 Assistant professor Department of Pharmaceutics M.pharm- 2 nd sem Dharmaj Degree Pharmacy College, Dharmaj. 1

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What is USFDA ??? The U.S. Food and Drug Administration (FDA or USFDA ) is an agency of the United States Department of Health and Human Services and is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. 2

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The FDA also enforces section 361 of the Public Health Service Act and the associated regulations including sanitation requirements on interstate travel as well as specific rules for control of disease for products ranging from pet turtles to semen donation for assisted reproductive medicine technique. 3

Important enabling legislation for the FDA includes: :

Important enabling legislation for the FDA includes: 1902 – Biologics Control Act 1906 – Pure Food and Drug Act 1938 – Federal Food, Drug, and Cosmetic Act 1944 – Public Health Service Act 1951 – 1951 Food, Drug, and Cosmetics Act Amendments 1962 – 1962 Food, Drug, and Cosmetics Act Amendments 1966 – Fair Packaging and Labeling Act 1976 – Medical Device Regulation Act 1987 – Prescription Drug Marketing Act 1988 – Anti–drug Abuse Act 1990 – Nutrition Labeling and Education Act 1992 – Prescription Drug User Fee Act 4

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1994 – Dietary Supplement Health and Education Act 1997 – Food and Drug Administration Modernization Act 2002 – Bioterrorism Act 2002 – Medical Device User Fee and Modernization Act 2003 – Animal Drug User Fee Act 2007 – Food and Drug Administration Amendments Act 2009 – Family Smoking Prevention and Tobacco Control Act 2010 – FDA Food Safety Modernization Act 5

Regulatory programs :

Regulatory programs The programs for safety regulation vary widely by the type of product, its potential risks, and 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 is focused primarily on labeling and safety. 6

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What is the need? 7

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OBLECTIVES OF FDA Better consumer information Enforcement &Correcting problem Keep watch on safe mfg & handling New Product Review Post Marketing safety Standard and regulation Monitoring for new risk Counter Terrorism 8

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Component Full Form Regulates CBER Center For Biologics Evaluation And Research Biological Products CDRH Center For Devices And Radiological Health Safety and Effectiveness of New Medical Devices Before they are Marketed CDER Center For Drug Evaluation And Research Health of by Assuring Prescription and OTC Drugs are Safe and Effective CSFAN Center For Food Safety And Applied Nutrition Food Supply is Safe, Sanitary, Wholesome, and Honestly Labeled, and Cosmetic Products are Safe and Properly Labeled. CVM Center For Veterinary Medicine Assure that Animal Food Products are Safe. NCTR National Center For Toxicological Research Human Toxicity OC Office Of The Commissioner ……………… ORA Office Of Regulatory Affairs Products Comply with Appropriate Public Health Laws and Regulations . 10


CBER CBER regulates biological products to advancing the public health through innovative regulations that ensure- the safety effectiveness and timely delivery to patients of biological products. Current authority for this responsibility resides in Section 351 of the Public Health Service Act and in specific sections of the Food Drug and Cosmetic Act. The mission of CBER is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, tissue, allergenic and biological therapeutics. 11




CDER The FDA's Center for Drug Evaluation and Research (CDER) promotes and protects the health, by assuring that all prescription and over-the-counter drugs are safe and effective. CDER evaluates all new drugs before they are sold, and serves as a consumer guide for the more than 10,000 drugs on the market to be sure they continue to meet the highest standards. 13


CFSAN The Center for Food Safety and Applied Nutrition, known as CFSAN, is one of six product-oriented centers, in addition to a nationwide field force, that carry out the mission of the Food and Drug Administration (FDA). The mission of CFSAN is, promoting and protecting the public's health by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled. Scope as follow, 14

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The safety of substances added to food, like food and color additives. The safety of foods and ingred . developed through biotechnology. Seafood hazard analysis and critical control point (HACCP) regulations. Health risks associated with food borne chemical , and biological contaminants. Regulations and activities dealing with the proper labeling of foods and cosmetics . Policy governing the safety of dietary supplements, infant formulas, and medical foods . Food industry postmarketing surveillance and compliance. Consumer education and industry outreach. Cooperative programs with state and local governments. 15

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Some of CFSAN's current areas of food safety concern are: biological pathogens (e.g., bacteria, viruses, parasites) naturally occurring toxins (e.g., mycotoxins , ciguatera toxin, paralytic shellfish poison) dietary supplements (e.g., ephedra ) pesticide residues toxic metals (e.g., lead, mercury) decomposition and filth (e.g., insect fragments) food allergens (e.g., eggs, peanuts, wheat, milk) nutrient concerns (e.g., vitamin D overdose, pediatric iron toxicity) dietary components (e.g., fat, cholesterol) radionuclide product tampering 16


CVM The FDA's Center for Veterinary Medicine (CVM) evaluates the safety and effectiveness of drugs used to treat animals. Nearly 300 drugs currently on the market have been approved by the FDA for dogs, cats and horses. CVM has two top priorities: Prevent the establishment of bovine spongiform encephalopathy (BSE), "mad cow disease." & Counter the risk of antibiotic resistance in humans from animal food. CVM regulates the manufacture and distribution of food additives and drugs that will be given to animals. CVM is responsible for regulating drugs, devices, and food additives given to animals like poultry, cattle, swine, and minor animal species (other than cattle, swine, chickens, turkeys, horses, dogs, and cats). 17


NCTR All of the research performed at the National Center for Toxicological Research is targeted to fulfill  three strategic research goals in support of FDA's public health mission. Risk Assessment for Regulated Products Knowledge Bases that Predict Human Toxicity Methods use for FDA Standard Development and Product Risk Surveillance NCTR includes, 18

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OC The Office of the Commissioner is made up of several components, Ethics Program Good Clinical Practice Program History Office Office of Combination Products Office of Crisis Management Office of Equal Employment Opportunity and Diversity Management Office of Financial Management Office of International Programs Office of the Ombudsman Office of Orphan Products Development Office of Pediatric Therapeutics Office of Planning Office of Policy Office of Public Affairs Office of Special Health Issues Office of Women's Health Small Business Program 21


ORA to ensure that FDA regulated products comply with appropriate public health laws and regulations. Compliance Strategies of ORA includes, Providing information to industry Highlighting areas of significant violations and impact on public health Prioritizing and targeting high-risk areas Cooperating with state and local public health authorities and regulators Focusing on covering products imported into the US through border coverage and foreign inspections. 22


COSMETICS FDA is only able to regulate cosmetics after products are released to the marketplace. Neither cosmetic products nor cosmetic ingredients (except color additives) are reviewed or approved by FDA before they are sold to the public. Includes, Animal Testing for Cosmetic Products Inspection of Cosmetics Shelf life Federal Food, Drug, and Cosmetic Act (FD&C Act) and Fair Packaging and Labeling Act (FPLA) 23

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24 Inspection FDA

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25 review all the processes and systems. Training to key staff, Ideally, create a company statement on audit behavior, be honest with the team and cooperate Train personnel to answer the question directly and concisely. do not guess ensure necessary regulatory follow-ups are done. Preparation……….US FDA inspection

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26 The procedure for responding to FDA activities includes prompt supply of photographs, electronic data, entering controlled areas and sampling. Do not discard of warning letter , it can result in discontinuation of inspection and issuance of further warning letters. units should conduct internal audits and analyze quality data - deviations, rejects etc. Identify the inspection team members, and define their roles and responsibilities (including back-up) like receptionist, trained facilitators and employees, note takers and subject experts.

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27 Findings like all systems are not compliant and follow-up could result in further enforcement action and freezing of products in pipeline, can also result in discontinuation of inspection Develop a strategy to the inspection closeout. assure documents/items are ready and available. It is necessary to effectively control your documents, Discuss with them openly Identify the logistics of the inspection, especially Who?, What?and Where?

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28 compare inspection observations with the observations listed on the FDA-483 At the end of inspection, accept the FDA-483 and check out whether all statements during inspection closeout are included Promise corrective actions After the inspection, plan, discuss, and respond in writing to the FDA-483 and determine if a regulatory attorney or consultant should review the FDA-483 and the response before delivery. analyze, how many observations did you miss?


Reference 29

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