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 Rexrode II (Recording start-time: 00:23) - Office of Clinical Policy and Programs Overview, Patient Affairs, and Good Clinical Practice 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
Lauren Roth (Recording start-time: 1:44:32) - Drug Regulation
Kavita Dada (Recording start-time: 2:13:30) - Device Regulation
Ariel Seeley (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
Kelly McCormick (Recording start-time: 3:35:20) - Overview of the Family Smoking and Prevention And Tobacco Control Act
Tamika Hopkins (Recording start-time: 4:02:22) - FDA and the Legislative Branch
Uchenna Alexander (Recording start-time: 4:30:12) - The Office of Women’s Health Overview
Erin South, PharmD (Recording start-time: 4:50:50) - Overview of FDA’s One Health Initiative
Brianna Skinner, DVM, MPH, DACLAM CAPT. USPHS (Recording start-time: 5:05:00)
3. FDA's medical product and tobacco responsibilities
- Phases of Drug Review Process
Mark Hirsch, MD (Recording start-time: 00:00:51) - Pre-IND and IND Review Process
Callie CappelLynch, PharMD, RAC (Recording start-time: 00:51:30) - NDA/BLA Review Process
ShinYe Chang, PharmD, MS, RAC (Recording start-time: 01:31:59) - Medical Device Review at CDRH
Mary Wen (Recording start-time: 02:23:41) - Electronic Product Radiation Control (Radiological Health)
Daniel Kassiday (Recording: start-time: 3:15:33) - Generic Drugs
LCDR Yen Anh Bui, PharmD (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
Y Hguyen (Recording: start-time: 5:49:10) - Blood Regulation
Jennifer Scharpf, MPH (Recording: start-time: 6:14:32) - Vaccine Regulation
Brynn Hollingsworth (Recording start-time: 6:44:32)
4. FDA's food and veterinary medicines responsibilities
- Post Marketing Activities
Phuong B Nguyen, RPh, GWCPM, CQIA, LCDR Zachary Oleszczuk, PharmD, MSPharm, BCGP, Amy Chen, PharmD (Recording: start-time: 1:00) - Device Post Marketing Activities
Martha Betz, PhD (Recording: start-time: 31:00) - Tobacco Compliance and Enforcement
Sheritta Taylor (Recording: start-time: 59:32) - Office of Minority Health and Health Equity
Anthony Welch (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
Nicolas Long (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
Virunya Bhat (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) - CDER Compliance
Jill Furman, JD (Recording: start-time: 3:16:57)
6. FDA regulatory research
- Toxicological Research
Jess Hawes (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
Diane Hao (Recording: start-time: 1:36:08) - Veterinary Research
Michael Myers, PhD (Recording: start-time: 2:01:56) - 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)
