USFDA Regulations and Guidelines for Pharmaceutical Products
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This document provides an overview of the US Food and Drug Administration (FDA) in 3 paragraphs. It discusses that the FDA was formed in 1906 and is responsible for regulating foods, drugs, medical devices, and other products. It describes the FDA's structure and responsibilities across its centers and offices. The document also provides brief summaries of the FDA approval processes for drugs, medical devices, and food products.
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USFDA Regulations and Guidelines for Pharmaceutical Products
- 1. school of pharmaceutical science (sops, utd-rgpv, Bhopal (m.p.) Prepared Bysana iram M.PHARM (Q.A) 1st sem.
- 2. Mission, vision and organistional structure of USFDA U.S Federal partners Responsibility Act and Regulations Overview of guidelines R & D process IND, NDA and ANDA US FDA preperation References
- 3. Formed ◦ ◦ ◦ ◦ 1906 Preceding agencies Food, Drug, and Insecticide Administration (July 1927 to July 1930) Bureau of Chemistry, USDA (July 1901 through July 1927) Division of Chemistry, USDA (established 1862) Jurisdiction Federal government of the United States Headquarters White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993 39°02′07″N 76°58′59″W Employees 9,300 Annual budget $4.36 billion Agency executive Dr. Margaret Hamburg, Commissioner of Food and Drugs [3] Parent Agency Department of Health and Human Services Child agencies Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research Center for Food Safety and Applied Nutrition Center for Tobacco Products Center for Veterinary Medicine National Center for Toxicological Research Office of Criminal Investigations Office of Regulatory Affairs Website www.fda.gov Laboratories Thirteen States Fifty
- 4. The 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.
- 5. 1902 – Biologics Control Act 1906 – Pure Food and Drug Act 1938 – Federal Food, Drug, and Cosmetic Act 1944 – Public Health Service Act 1951 – Food, Drug, and Cosmetics Act Amendments 1962 – Food, Drug, and Cosmetics Act Amendments 1966 – Fair Packaging and Labeling Act 1976 – Medical Device Regulation Act 1987 – Prescription Drug Marketing Act 5
- 6. 1988 – Anti–drug Abuse Act 1990 – Nutrition Labeling and Education Act 1992 – Prescription Drug User Fee Act 1994 – Dietary Supplement Health and Education Act 1997 – Food and Drug Modernization Act 2002 – Bioterrorism Act 2002 – Medical Device User Fee and Modernization Act (MDUFMA) 2003 – Animal Drug User Fee Act 2007 – Food and Drug Administration Amendments Act of 2007 6
- 7. Public demands action Congress enacts general law FDA proposes science-based regulations to put the law into effect Regulations are notified, finalized and published in 21 Code of Federal Regulations (CFR) FDA assures compliance by enforcement and inspections that are targeted by risk assessment Industry has the ultimate responsibility to produce safe foods 7
- 8. FDA regulates interstate commerce Transparency Same standards for domestic and international Science-based regulations Consistency and predictability of implementation 8
- 9. Department of Health and Human Services (HHS) ◦ Food and Drug Administration (FDA) ◦ Centers for Disease Control and Prevention (CDC) Department of Agriculture (USDA) ◦ Food Safety and Inspection Service (FSIS) ◦ Animal and Plant Health Inspection Service (APHIS) ◦ Foreign Agricultural Service (FAS) Environmental Protection Agency (EPA) Bureau of Customs and Border Protection (CBP) Alcohol and Tobacco Tax and Trade Bureau (TTB) 9
- 10. Protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled; human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective Protecting the public from electronic product radiation Assuring cosmetics and dietary supplements are safe and properly labeled Regulating tobacco products Advancing the public health by helping to speed product innovations Helping the public get the accurate science-based information they need to use medicines, devices, and foods to improve their health FDA’s responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions.
- 11. The Office of the Commissioner (OC) The Center for Drug Evaluation and Research (CDER) The Center for Biologics Evaluation and Research (CBER) The Center for Food Safety and Applied Nutrition (CFSAN) The Center for Devices and Radiological Health (CDRH) The Center for Veterinary Medicine (CVM) The National Center for Toxicological Research (NCTR) The Office of Regulatory Affairs (ORA) The Office of Criminal Investigations (OCI)
- 12. 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 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.
- 13. Food Drugs Medical Devices * Biologics Animal Feed and Drugs Cosmetics Radiation-Emitting Products * Combination Products (drug-device*, biologicdevice*, drug-biologic) * CDRH Center for Devices and Radiological Health CDER Center for Drugs and Evaluation Research CBER Center for Biologics and Evaluation Research FDA CVM Center for Veterinary Medicine CFSAN Center for Food Safety and Applied Nutrition NCTR National Center for Toxicological Research
- 14. Efficient, Efficient, Effective, Effective, and Predictable and Predictable Product Product Development Development Ensuring Ensuring the Safety of the Safety of Marketed Marketed Medical Devices Medical Devices Enabling Enabling Technology Technology and Innovation and Innovation
- 15. Foods ◦ safety of all food products (except for most meat and poultry products, which are regulated by the U.S. Department of Agriculture) ◦ labeling ◦ bottled water ◦ food additives ◦ infant formulas Dietary Supplements Human Drugs ◦ ◦ ◦ ◦ ◦ ◦ ◦ product approvals OTC and prescription drug labeling drug manufacturing standards Vaccines, Blood Products, and Other Biologics product and manufacturing establishment licensing safety of the nation's blood supply research to establish product standards and develop improved testing methods
- 16. Medical Devices from simple items like tongue depressors, to complex technologies such as heart pacemakers premarket approval of new devices manufacturing and performance standards tracking reports of device malfunctioning and serious adverse reactions Electronic Products products that give off radiation, such as microwave ovens and X-ray equipment radiation safety performance standards for microwave ovens, television receivers, diagnostic x-ray equipment, cabinet x-ray systems (such as baggage x-rays at airports), laser products, ultrasonic therapy equipment, mercury vapor lamps, and sunlamps accrediting and inspecting mammography facilities Cosmetics safety labeling Veterinary Products livestock feeds pet foods veterinary drugs and devices veterinary biologics not regulated by USDA are considered new animal drugs Tobacco Products
- 17. CFR Title 21 (Code Of Federal Regulation) - Food and Drugs: Parts 1 to 1499 different types of parts to food, drug , cosmetic and medical devices and etc For Conducting a clinical research on IND different imp parts is their
- 18. 21 CFR part 11- Electronic submission and Electronic signature 21 CFR part 50- Protection of human subjects 21 CFR part 54- Financial Disclosure by Clinical Investigators 21 CFR part 56- Institutional Review Board 21 CFR part 312- Investigational new drug application 21 CFR part 314- Application for FDA Approval to Market a New Drug
- 20. Foods are safe, wholesome and sanitary; Human and veterinary drugs and medical devices are safe and effective; Human biologics are safe and effective; Cosmetics are safe; Electronic products that emit radiation are safe; and Labeling for these products honestly represents them to users, and their instructions for use are adequate.
- 21. Development Preclinical studies Early Clinical Development CHEMISTRY/ PHARMACOLOGY IND* PHASE I PHASE II PHASE III NDA** PHASE IV Search for active substances Regulatory review Efficacy studies on healthy volunteers Clinical studies on a limited scale Regulatory review Continued comparative studies 50–150 persons 100–200 patients Comparativ e studies on a large number of patients 20/12/13 Discovery Clinical studies *Investigational New Drug Application for permission to administer a new drug to humans Toxicology, efficacy studies on various types of animals KNOWLEDGE LEVEL 500–5,000 patients LEVEL KNOWLEDGE Registration, market introduction **New Drug Application Application for permission to market a new drug TIME SPAN 2–4 yrs. 2–6 months 3–6 yrs. 1–3 yrs. Approximately 10–15 years from idea to marketable drug 21
- 24. (NDA) Requirements (ANDA) Requirements 1. Labeling 1. Labeling 2. Pharm / Tox 2. Pharm / Tox 3. Chemistry 3. Chemistry 4. Manufacturing 4. Manufacturing 5. Controls 5. Controls 6. Microbiology 6. Microbiology 7. Inspection 7. Inspection 8. Testing 8. Testing 9. Animal Studies 10. Clinical Studies 9. Bioequivalence 11. Bioavailability Labeling ◦ “Same” information as brand name labeling ◦ May delete portions of labeling protected by patent or exclusivity (i.e., an indication, strength) ◦ May differ in excipients and product description (i.e., colors, shapes)
- 25. FDA inspects manufacturers or processors of FDA-regulated products to verify that they comply with relevant regulations. Those inspected include vaccine and drug manufacturers blood banks food processing facilities dairy farms animal feed processors FDA also inspects facilities that conduct studies in people (clinical trials) laboratories that conduct studies in animals or microorganisms when these studies are used to apply for FDA approval of a medical product foreign manufacturing and processing sites for FDA-regulated products that are sold in the United States imported products at the border
- 26. Source: Newport Horizon Premium™
- 31. Register facility with FDA Register process for canning/aseptic packaging of Low Acid/Acidified Canned Foods (LACF) Use good practices in food production ◦ Agricultural ◦ Aquacultural ◦ Manufacturing ◦ HACCP Assure that the product is safe, wholesome, sanitary, properly packaged and labeled Give “Prior Notice” 31
- 32. 1. 2. 3. 4. 5. 6. Drugs and Cosmetic Act, 1940, Govt. of India Drugs and Cosmetic Rules, 1945, Govt. of India. Office of Generic Drugs Home Page: ttp://www.fda.gov/cder/ogd/index.htm On line training program: http://www.fda.gov/cder/learn/CDERLearn/gen DrugProcess/transcript.htm http://www.fda.gov/cder/orange/default.htm www.cdsco.nic.in
Notas del editor
- Origins The U S. Food and Drug Administration is a scientific, regulatory, and public health agency that oversees items accounting for 25 cents of every dollar spent by consumers. Its jurisdiction encompasses most food products (other than meat and poultry), human and animal drugs, therapeutic agents of biological origin, medical devices, radiation-emitting products for consumer, medical, and occupational use, cosmetics, and animal feed. The agency grew from a single chemist in the U.S. Department of Agriculture in 1862 to a staff of approximately 9,100 employees and a budget of $1.294 billion in 2001, comprising chemists, pharmacologists, physicians, microbiologists, veterinarians, pharmacists, lawyers, and many others. About one-third of the agency's employees are stationed outside of the Washington, D. C. area, staffing over 150 field offices and laboratories, including five regional offices and 20 district offices. Agency scientists evaluate applications for new human drugs and biologics, complex medical devices, food and color additives, infant formulas, and animal drugs. Also, the FDA monitors the manufacture, import, transport, storage, and sale of about $1 trillion worth of products annually at a cost to taxpayers of about $3 per person. Investigators and inspectors visit more than 16,000 facilities a year, and arrange with state governments to help increase the number of facilities checked. HISTORY The legislation having failed to develop, the Secretary of HEW commissioned the Study Group on Medical Devices, which recommended in 1970 that medical devices be classified according to their comparative risk, and regulated accordingly. The 1976 Medical Device Amendments, coming on the heels of a therapeutic disaster in which thousands of women were injured by the Dalkon Shield intrauterine device, provided for three classes of medical devices, each requiring a different level of regulatory scrutiny--up to pre-market approval. 1976 MEDICAL DEVICE AMENDMENTS passed to ensure safety and effectiveness of medical devices, including diagnostic products. The amendments require manufacturers to register with FDA and follow quality control procedures. Some products must have pre-market approval by FDA; others must meet performance standards before marketing.
- TOTAL PRODUCT LIFE CYCLE MODEL (TPLC) is applied across Center activities to promote and protect the public heath. Total Product Life Cycle (TPLC) is an integrated product development scheme and a conceptual framework for assessing a variety of industrial and clinical models. For the manufacturer TPLC is the market-driven evolution of a device, drug, or biologic from initial conception, through pre-market development, to widespread market use, and finally to obsolescence and replacement by subsequent generations of products.
- There are various ways of illustrating the R&D process – this is one. We see, among other things, how knowledge about a drug increases during the course of the process, but that upon market introduction, there is still a great deal to be learned about how the drug works in the body. Developing a new drug is a complex and costly process. If everything goes according to plan, a new drug will be ready approximately ten years after the work was first begun. We are working to shorten this time to eight years. Pharmaceutical companies are constantly striving to shorten the time from idea to finished pharmaceutical product. At the same time, the demands on documentation continue to rise.
- Lets look at where these inspections have taken place. Almost a third of them have been in the U.S., which makes sense. But there is also plenty of presence by the FDA in India, Italy, and China and that is expected to increase over coming years.