Module 5 Presentations

18/07/2024

The Food and Drug Administration

 The FDA is an agency within the Department of Health and Human Services of the US government.  Effective March 31, 2019, FDA began the implementation of an agency reorganization, to meet the challenges of rapid innovation across the industries regulated by FDA.

 The FDA has multiple regulatory responsibilities including: – Food Safety and Nutrition (labeling, additives, dietary supplements) – Drugs (prescription and non-prescription) – Devices – Vaccines, blood products and biologicals (gene therapy products) – Veterinary products (animal drugs, feeds, devices) – Cosmetics – Radiation-emitting products – Tobacco products

The Organisation for Professionals in Regulatory Affairs

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FDA Organization

FDA consists of nine Center-level organizations and thirteen Headquarter (HQ) Offices. The Center-level organizations include the following:

● Center for Drug Evaluation and Research (CDER) – 12 Offices including, Office of New Drugs ● Center for Biologics Evaluation and Research (CBER) – ● Center for Devices and Radiological Health (CDRH) ● Center for Food Safety and Applied Nutrition

8 Offices including, Office of Blood Research and Review, Office of Vaccines Research and Review and the Office of Therapeutic Products (OTP).

● Centre for Tobacco Products ● Centre for Veterinary Medicine ● National Center for Toxicological Research ● Office of Regulatory Affairs ● Office of Operations ● Oncology Center of Excellence

The Organisation for Professionals in Regulatory Affairs

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