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CONTENT 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

Food & Drug Administration – An overview:

Food & Drug Administration – An overview 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 Laboratories Thirteen States Fifty

Defination of FDA::

Defination of FDA: 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.

FDA-Legal authoritys:

FDA-Legal authoritys 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

FDA-Legal authoritys:

FDA-Legal authoritys 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

How it Works: Rule-making Process and Enforcement Strategy:

How it Works: Rule-making Process and Enforcement Strategy 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

Important Aspects of the U.S. System:

Important Aspects of the U.S. System FDA regulates interstate commerce Transparency Same standards for domestic and international Science-based regulations Consistency and predictability of implementation 8

U.S. Federal Partners for the Food Safety System:

U.S. Federal Partners for the Food Safety System 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


Responsibility 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.


FDA-Organizations 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)

PowerPoint Presentation:

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.

FDA Centers and Regulated Products:

FDA Centers and Regulated Products Food Drugs   Medical Devices * Biologics Animal Feed and Drugs Cosmetics Radiation-Emitting Products * Combination Products ( drug-device * , biologic-device * , drug-biologic) *

CDRH manages risk across the “Total Product Life Cycle” applied across Center activities …:

CDRH manages risk across the “Total Product Life Cycle” applied across Center activities …

Items regulated:

Items regulated 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

Items regulated:

Items regulated 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

CFR Title 21:

CFR Title 21 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

FDA Guidelines to conduct clinical trials :

FDA Guidelines to conduct clinical trials 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



US FDA’s Responsibilities are to ensure that::

US FDA’s Responsibilities are to ensure that: 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.


THE R&D PROCESS Development Discovery Development Approximately 10–15 years from idea to marketable drug Preclinical studies Clinical studies CHEMISTRY/ PHARMA- COLOGY IND* PHASE I PHASE II PHASE III NDA** PHASE IV Search for active substances Toxicology, efficacy studies on various types of animals Regulatory review Efficacy studies on healthy volunteers Clinical studies on a limited scale Comparative studies on a large number of patients Regulatory review Continued comparative studies * Investigational New Drug Application for permission to administer a new drug to humans 50–150 persons 100–200 patients 500–5,000 patients Registration, market introduction **New Drug Application Application for permission to market a new drug KNOWLEDGE LEVEL KNOWLEDGE LEVEL 2–4 yrs. 2–6 months 3–6 yrs. 1–3 yrs. TIME SPAN Early Clinical 14/10/2013 21

NDA vs. ANDA Review Process:

NDA vs. ANDA Review Process (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)

What does FDA inspect? :

What does FDA inspect? 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

Number of API Manufacturing Plants Inspected by US FDA: 2001 – 2007:

Number of API Manufacturing Plants Inspected by US FDA: 2001 – 2007 Source: Newport Horizon Premium™

Preparation….US FDA INSPECTION :


How to Export Food to the U.S.:

How to Export Food to the U.S. 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


References Drugs and Cosmetic Act, 1940, Govt. of India Drugs and Cosmetic Rules, 1945, Govt. of India. Office of Generic Drugs Home Page: ttp:// On line training program: DrugProcess/transcript.htm

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