FINAL USFDA

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UNITED STATES FOOD AND DRUG ADMINISTRATION:

UNITED STATES FOOD AND DRUG ADMINISTRATION PREPARED BY: SHWETA KALASARE M.PHARM 2nd semester GUIDED BY: Mrs. JYOTSNA CHOPADE

Content: -:

Content: - What is USFDA? What is the need? FDA Objective FDA Components FDA Mission Preparation of FDA Inspections References 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 2

1. What is USFDA???:

1. 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. 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 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 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 4

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 :

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 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 5

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8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 6 2. What is the need?

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8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 7 3.OBJECTIVES OF FDA Better consumer information Post marketing saftey Counter Terrorism New product review Enforcement & Correcting problem Standard and regulation Keep watch on safe mfg & handling Monitoring for new risk

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8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 8

Conti..:

Conti.. 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. 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 9

4A. CBER:

4A. 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. 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 10

PRODUCTS REGULATED BY CBER :

PRODUCTS REGULATED BY CBER A. Blood. B. Devices. C. Vaccines D. Tissue. E. Human Tissue & Cellular products. F. Allergenics. 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 11

4B. CDRH:

4B. CDRH 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 12

4C. CDER:

4C. 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 drugs on the market to be sure they continue to meet the highest standards. 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 13

4D. CFSAN:

4D. 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. 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 14

Cont…:

Cont… Scope as follow, The safety of substances added to food, like food and color additives. The safety of foods and ingred. developed through biotechnology. Health risks associated with food borne chemical, and biological contaminants. Regulations and activities dealing with the proper labeling of foods. Food industry post marketing surveillance and compliance. Consumer education. Cooperative programs with state and local governments. 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 15

Some of CFSAN's current areas of food safety concern are: 1. Biological pathogens (e.g., bacteria, viruses, parasites) 2.Naturally occurring toxins (e.g., mycotoxins , ciguatera toxin, paralytic shellfish poison) 3.Dietary supplements (e.g., ephedra ) 4.Pesticide residues toxic metals (e.g., lead, mercury) 5.Decomposition and filth (e.g., insect fragments) 6.Food allergens (e.g., eggs, peanuts, wheat, milk) 7.Nutrient concerns (e.g., vitamin D overdose, pediatric iron toxicity) 8.Dietary components (e.g., fat, cholesterol) 9.Radionuclide 10.Product tampering :

Some of CFSAN's current areas of food safety concern are: 1. Biological pathogens (e.g., bacteria, viruses, parasites) 2.Naturally occurring toxins (e.g., mycotoxins , ciguatera toxin, paralytic shellfish poison) 3.Dietary supplements (e.g., ephedra ) 4.Pesticide residues toxic metals (e.g., lead, mercury) 5.Decomposition and filth (e.g., insect fragments) 6.Food allergens (e.g., eggs, peanuts, wheat, milk) 7.Nutrient concerns (e.g., vitamin D overdose, pediatric iron toxicity) 8.Dietary components (e.g., fat, cholesterol) 9.Radionuclide 10.Product tampering 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 16

4E. CVM:

4E. 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. 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 17

4F. NCTR:

4F. 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 include: 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 18

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8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 19

4G. OC:

4G. OC The Office of the Commissioner is made up of several components, Ethics Program Good Clinical Practice Program Office of International Programs 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 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 20

4H. ORA:

4H. 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. 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 21

4I. COSMETICS:

4I. 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 Cosmetic labeling 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 22

I. Animal Testing for Cosmetic Products:

I. Animal Testing for Cosmetic Products FDA does not mandate to do animal testing FDA develop validated alternatives to animal testing in assessing cosmetic safety 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 23

II. Inspection of Cosmetics:

II. Inspection of Cosmetics An investigator may look for the following, Use of prohibited ingredients Improper use of restricted ingredients noncompliance with requirements related to color additives Microbial contamination Failure to adhere to requirements for tamper-resistant packaging Deficiencies in labeling and packaging 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 24

III. Shelf Life:

III. Shelf Life No regulations or requirements under current united states law Manufacturers have the responsibility to determine shelf life for products 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 25

IV. Cosmetic Labeling:

IV. Cosmetic Labeling The name of manufacturer, packer or distributor Place of business of the manufacturer, packer or distributor An accurate statement of the quantity of contents Any appropriate directions for safe use and Warning statements 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 26

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8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 27

5A. MISSION STATEMENT:

5A. MISSION STATEMENT The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, cosmetics, and products that emit radiation. And helping the public to get the accurate, science-based information they need to use medicines and foods to improve their health. 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 28

5C. WHAT FDA REGULATES:

5C. WHAT FDA REGULATES Biologics Product and manufacturing establishment licensing Safety of the nation's blood supply Research to establish product standards and develop improved testing methods Cosmetics Safety Labeling Drugs Product approvals OTC and prescription drug labeling Drug manufacturing standards 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 29

Cont…:

Cont… 12. Safety of all food products Medical devices Manufacturing and performance standards Tracking reports of device malfunctioning and serious adverse reactions Radiation-emitting electronic products 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 Veterinary products 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 30

5D. WHAT FDA DOES NOT REGULATE:

5D. WHAT FDA DOES NOT REGULATE Advertising Alcohol Consumer Products Drugs of Abuse Health Insurance Pesticides Restaurants and Grocery Stores Water 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 31

6. Preparation of FDA Inspection….:

6. Preparation of FDA Inspection…. 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 . 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 32

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.:

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. 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 33

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?   :

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?   8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 34

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? :

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? 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 35

7. Reference:

7. Reference www.fda.gov www.hhs.gov 8 December 2014 Prepared by Shweta Kalasare Pad.Dr.D.Y.Patil College of Pharmacy 36

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