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 – Jeffery B. Rexrode II
(Recording: start-time: 8:20) - Office of Clinical Policy and Programs Overview, Patient Affairs, and Good Clinical Practice – Allison Hoffman
(Recording: start-time: 14:31) - Office of Combination Products, Product Classification & Jurisdiction – Diana Yoon
(Recording: start-time: 27:06) - Office of Pediatric Therapeutics – Melanie Bhatnagar
(Recording: start-time: 51:07) - Office of Orphan Products Development, Rare Pediatric Diseases, and Grants Programs – Erika Torjusen
(Recording: start-time: 58:49)
2. FDA's regulatory framework
- FDA’s Regulatory Framework – Jarilyn Dupont, J.D.
(Recording: start-time: 1:21:00) - Drug Regulation – Mathew Thomas
(Recording: start-time: 2:01:33) - Device Regulation – Jonette Foy, PhD
(Recording: start-time: 2:09) - A Brief History Of Biological Product Regulation – Denise Zavagno
(Recording: start-time: 10:19) - U.S. Food Safety System Overview – Eric L. Stevens, PhD
(Recording: start-time: 31:49) - Overview of the Family Smoking and Prevention And Tobacco Control Act – Rashad James
(Recording: start-time: 1:12:28) - FDA and the Legislative Branch – Yasemin Luebke
(Recording: start-time: 2:05:46) - The Office of Women’s Health Overview – Erin South
(Recording: start-time: 2:52:02)
3. FDA's medical product and tobacco responsibilities
- Phases of Drug Review Process – Mark Hirsh, MD
(Recording: start-time: 0:00) - Pre-IND and IND Review Process – Callie CappelLynch, Pharm.D, RAC
(Recording: start-time: 55:45) - NDA/BLA Review Process – Lawrence Allan
(Recording: start-time: 1:52:24) - Overview of Medical Device Regulation – Marjorie Shulman, MBA
(Recording: start-time: 2:46:46) - Electronic Product Radiation Control (Radiological Health) – Daniel Kassiday
(Recording: start-time: 5:25) - Generic Drugs – LCDR Yen Anh Bui
(Recording: start-time: 39:25) - Medical Device Review at CBER – Katherine Kim, MPH
(Recording: start-time: 1:20:49) - FDA’s Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products – Simone Porter MD, MPH
(Recording: start-time:1:43:36) - Cellular Therapy Products – Brian Niland, PhD
(Recording: start-time: 2:13:27) - Gene Therapies - Bo Liang
(Recording: start-time: 2:48:49) - Blood Regulation – Jennifer Scharpf, MPH
(Recording: start-time: 3:13:58) - Overview of Vaccine Regulation – Luba Vujcic
(Recording start-time: 3:46:43)
4. FDA's food and veterinary medicines responsibilities
- Post Marketing Activities – Darrell Lyons, BSN, RN
(Recording: start-time: 2:11:59) - Device Post Marketing Activities – Martha Betz
(Recording: start-time: 2:57:00) - Tobacco Compliance and Enforcement – Emil Wang
(Recording: start-time: 0:00) - Office of Minority Health and Health Equity – Cariny Nunez
(Recording: start-time: 37:13) - Food Safety - Risk Assessment and Identifying, Obtaining and Using Science to Make Food Safety Decisions – Yuhuan Chen, PhD
(Recording start-time: 1:05:57) - Food Safety – Inspections, Seizures and Recalls – Robyn Jones and Asha Dwarka
(Recording: start-time: 1:38:08) - Food Safety - Risk Communication – Howard Seltzer
(Recording: start-time: 2:26:18) - FDA’s Role in the Safety Assessment and Regulation of Food Ingredients – Karen Hall
(Recording: start-time: 3:02:53) - Cosmetics – Jo Huang, PhD
(Recording: start-time: 3:26:25) - Veterinary Products – Diane Heinz, DVM, MBA
- New Animal Drug Approval Process – Youssef (Joe) Zinoun
(Recording: start-time: 3:26:25) - Programs for Minor Uses and Minor Species – Stuart Jeffrey
(Recording: start-time: 3:26:25) - Center for Veterinary Medicine Surveillance and Compliance – Brittani Everson-Riley
(Recording: start-time: 3:26:25)
5. FDA's domestic and international product quality and safety efforts
- Office of Global Policy and Strategy (OGPS) Overview - Daniel Finan
(Recording: start-time: 7:25) - Our Borders and Beyond – Imports and Foreign Operations - Amanda Pasternak and Elizabeth Dahl (Jorgenson)
(Recording: start-time: 41:58) - Criminal Investigations – Imports and Foreign Operations - Scott Schillinger
(Recording: start-time: 1:16:04) - Compliance and Enforcement Operations - Armando Zamora
(Recording: start-time: 2:15:59) - District/Program Division Responsibilities – Ingrid Zambrana
(Recording: start-time: 3:36:14) - CDER Compliance – Margee Parikh Webster, Pharm.D
(Recording: start-time: 5:01:46)
6. FDA regulatory research
- Toxicological Research – Tucker A. Patterson, PhD
(Recording: start-time: 4:11) - Drug Research – Ruth Barratt, PhD, DVM
(Recording: start-time: 37:10) - Device Research - Ed Margerrison, PhD
(Recording; start-time: 59:26) - Food Safety Research - Karen R. Hatwell, PhD
(Recording: start-time: 2:06:15) - Veterinary Research – Hui Li, PhD
(Recording: start-time: 3:31:27) - Office of Regulatory Affairs (ORA) Science- Evgeny Kiselev, PhD
(Recording: start-time: 4:18:00) - Biologics Research – Monica L. Young, PhD
(Recording: start-time: 5:38:06) - FDA Center for Tobacco Products Regulatory Science Program - Evgeny Kiselev, PhD
(Recording: start-time: 5:54:36) - FDA’s Regulation of Intentional Genomic Alterations in Animals - Evgenij A. Evdokimov, MS, PhD and Stella Lee, PhD
(Recording: start-time: 6:29:39)