FDA 101: An Overview of FDA's Regulatory Review and Research Activities
FDA 101 offers a broad overview of FDA’s regulatory review and research activities as well as its product quality and safety responsibilities.
FDA gives the course annually in the spring to our staff, who learn about the scientific and regulatory knowledge needed to support FDA's public health and regulatory mission.
All speakers are FDA subject matter experts in their respective fields.
The course covers FDA's:
- Organizational components
- Regulatory framework
- Medical product and tobacco responsibilities
- Food and veterinary medicine responsibilities
- Domestic and international product quality and safety efforts
- Regulatory research
1. FDA’s organizational components
- Introduction to FDA – Sharron Watson
(Recording: start-time: 00:23) - Office of Clinical Policy and Programs Overview, Patient Affairs, and Good Clinical Practice – Allison Hoffman, Carmen Matos, and Karen Giardiello
(Recording: start-time: 34:43) - Office of Combination Products, Product Classification & Jurisdiction – Ifeanyi Uwemedimo, PhD
(Recording: start-time: 50:10) - Office of Orphan Products Development, Rare Pediatric Diseases, and Grants Programs – Erika Torjusen
(Recording: start-time: 1:03:50) - Office of Pediatric Therapeutics – Melanie Bhatnagar
(Recording: start-time: 1:23:48)
2. FDA's regulatory framework
- FDA’s Regulatory Framework – Jarilyn Dupont, J.D.
(Recording: start-time: 1:44:32) - Drug Regulation – Mathew Thomas
(Recording: start-time: 2:13:30) - Device Regulation – Jonette Foy, PhD
(Recording: start-time: 2:37:59) - A Brief History Of Biological Product Regulation – Mustafa Unlu
(Recording: start-time: 3:00:50) - U.S. Food Safety System Overview – Eric L. Stevens, PhD
(Recording: start-time: 3:35:20) - Overview of the Family Smoking and Prevention And Tobacco Control Act – Laura Chilaka, JD
(Recording: start-time: 4:02:22) - FDA and the Legislative Branch – Yasemin Luebke, JD
(Recording: start-time: 4:30:12) - The Office of Women’s Health Overview – Erin South, PharmD
(Recording: start-time: 4:50:50)
3. FDA's medical product and tobacco responsibilities
- Phases of Drug Review Process – Mark Hirsh, MD
(Recording: start-time: 00:51) - Pre-IND and IND Review Process – Callie CappelLynch, PharMD, RAC
(Recording: start-time: 51:30) - NDA/BLA Review Process – ShinYe Chang, PharmD, MS, RAC
(Recording: start-time: 1:31:59) - Medical Device Review at CDRH – Geeta Pamidimukkala
(Recording: start-time: 2:23:41) - Electronic Product Radiation Control (Radiological Health) – Daniel Kassiday
(Recording: start-time: 3:15:33) - Generic Drugs – LCDR Yen Anh Bui
(Recording: start-time: 3:56:37) - Medical Device Review at CBER – Katherine Kim, MPH
(Recording: start-time: 4:27:45) - Tissue Regulation – Simone Porter MD, MPH
(Recording: start-time: 4:50:29) - Cellular Therapy Products – Brian Niland, PhD
(Recording: start-time: 5:22:09) - Gene Therapies - Massoud Motamed, PhD
(Recording: start-time: 5:49:10) - Blood Regulation – Jennifer Scharpf, MPH
(Recording: start-time: 6:14:32) - Vaccine Regulation – Luba Vujcic, MS
(Recording start-time: 6:44:32)
4. FDA's food and veterinary medicines responsibilities
- Post Marketing Activities – CAPT Latonia Ford, RN, BSN, MBA; LCDR Zachary Oleszczuk, PharmD, MSPharm, BCGP and Amy Chen, PharmD
(Recording: start-time: 1:00) - Device Post Marketing Activities – Martha Betz, PhD
(Recording: start-time: 31:00) - Tobacco Compliance and Enforcement – Emil Wang, JD
(Recording: start-time: 59:32) - Office of Minority Health and Health Equity – Cariny Nunez, MPH, CHRM, COR
(Recording: start-time: 1:33:43) - Food Safety - Risk Assessment and Identifying, Obtaining and Using Science to Make Food Safety Decisions – Yuhuan Chen, PhD
(Recording start-time: 1:57:22) - Food Safety – Inspections, Seizures and Recalls – Robyn Jones
(Recording: start-time: 2:31:40) - Food Safety - Risk Communication – Howard Seltzer
(Recording: start-time: 2:54:57) - FDA’s Role in the Safety Assessment and Regulation of Food Ingredients – Karen Hall
(Recording: start-time: 3:29:28) - Cosmetics – Jo Huang, PhD
(Recording: start-time: 3:45:34) - Veterinary Products – Diane Heinz, DVM, MBA
Recording: start-time: 4:17:54) - New Animal Drug Approval Process – Ramez Khayat, MS, MBA, PMP
(Recording: start-time: 4:55:49) - Programs for Minor Uses and Minor Species – Stuart Jeffrey, DVM, MS
(Recording: start-time: 5:29:25) - Center for Veterinary Medicine Surveillance and Compliance – Brittani Everson-Riley, JD
(Recording: start-time: 5:52:24)
5. FDA's domestic and international product quality and safety efforts
- Office of Global Policy and Strategy (OGPS) Overview – Karen Riley, MPH
(Recording: start-time: 00:43) - Our Borders and Beyond – Imports and Foreign Operations – Amanda Pasternak, BS and Susan Shaffer, REHS/RS
(Recording: start-time: 30:46) - Criminal Investigations – Scott Schillinger
(Recording: start-time: 1:15:29) - Compliance and Enforcement Operations – Catherine Beer, MS; Jessica Kocian, MPH and Sherrie Krolczyk
(Recording: start-time: 1:49:35) - District/Program Division Responsibilities – Ingrid Zambrana
(Recording: start-time: 2:23:54) - CDER Compliance – Jill Furman, JD
(Recording: start-time: 3:16:57)
6. FDA regulatory research
- Toxicological Research – Gonçalo Gamboa da Costa, PhD
(Recording: start-time: 01:18) - Drug Research – Ruth Barratt, PhD, DVM
(Recording: start-time: 35:50) - Device Research – Anton Dmitriev
(Recording; start-time: 31:07) - Food Safety Research – Karen R. Hatwell, PhD
(Recording: start-time: 1:36:08) - Veterinary Research – Daniel Tadesse, DVM, PhD
(Recording: start-time: 2:01:56) - Office of Regulatory Affairs (ORA) Science – Evgeny Kiselev, PhD
(Recording: start-time: 3:02:00) - Biologics Research – Monica Young, PhD
(Recording: start-time: 3:57:38) - Regulation of Intentionally Altered Genomic DNA in Animals at FDA – Evgenij A. Evdokimov, MS, PhD and Stella Lee, PhD
(Recording: start-time: 4:19:49) - CTP’s Tobacco Regulatory Research Program – Dana van Bemmel, PhD, MPH
(Recording: start-time: 4:52:00)
