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 componentsExternal Link Disclaimer
- Regulatory framework
- Medical product and tobacco responsibilitiesExternal Link Disclaimer
- Food and veterinary medicine responsibilitiesExternal Link Disclaimer
- Domestic and international product quality and safety effortsExternal Link Disclaimer
- Regulatory researchExternal Link Disclaimer
1. FDA’s organizational components
- Introduction to FDA
Sharron Watson (Recording start-time: 00:00External Link Disclaimer) - Office of Clinical Policy and Programs Overview, Patient Affairs, and Good Clinical Practice
Jessica Cades PhD (Recording start-time: 10:00External Link Disclaimer) - Patient Affairs: The FDA’s Front Door
Carmen Matos (Recording start-time: 15:28External Link Disclaimer) - Office of Combination Products, Product Classification & Jurisdiction
Ifeanyi Uwemedimo, PhD (Recording start-time: 34:59External Link Disclaimer) - Office of Orphan Products Development, Rare Pediatric Diseases, and Grants Programs
Erika Torjusen, MD, MHS (Recording start-time: 52:55External Link Disclaimer) - Office of Pediatric Therapeutics
Melanie Bhatnagar (Recording start-time: 1:10:02External Link Disclaimer)
2. FDA's regulatory framework
- FDA’s Regulatory Framework
Lauren Roth (Recording start-time: 1:35:30External Link Disclaimer) - Drug Regulation
Kavita Dada, PharmD, RAC (Recording start-time: 2:17:00External Link Disclaimer) - Device Regulation
Ariel Seeley (Recording start-time: 2:39:39External Link Disclaimer) - A Brief History Of Biological Product Regulation
Mustafa Unlu (Recording start-time: 3:19:28External Link Disclaimer) - U.S. Food Safety System Overview
Kelly McCormick (Recording start-time: 3:55:48External Link Disclaimer) - Overview of the Family Smoking and Prevention And Tobacco Control Act
Adriran Mixon, JD (Recording start-time: 4:21:31External Link Disclaimer) - FDA and the Legislative Branch
Paul Aguilar (Recording start-time: 4:37:33External Link Disclaimer) - The Office of Women’s Health Overview
Erin South, PharmD (Recording 2, start-time: 12:39External Link Disclaimer) - Overview of FDA’s One Health Initiative
Brianna Skinner, DVM, MPH, DACLAM CAPT. USPHS (Recording 2, start-time: 37:21External Link Disclaimer)
3. FDA's medical product and tobacco responsibilities
- Day 2 Summary and Overview of Day 3
Sharron Watson, Training Specialist, OSPD (Recording start-time 0:00:00External Link Disclaimer) - Post Marketing Activities
Phuong B. Nguyen, RPh, GWCPM, CQIA
Barbrakaryne Nchinda Fobi, PharmD, MPH
Amy Chen, Pharm D (Recording start-time: 00:51External Link Disclaimer) - Device Post Marketing Activities
Carrie Voycheck, PhD (Recording start-time: 25:01External Link Disclaimer) - Tobacco Compliance and Enforcement
Loretta Chi, JD (Recording start-time: 2:08:10External Link Disclaimer) - Food Safety - Risk Assessment and Identifying, Obtaining and Using Science to Make Food Safety Decisions
D Sarah Murphy, PhD (Recording start-time: 1:10:50External Link Disclaimer) - Food Safety – Inspections, Seizures and Recalls
Nicholas Long (Recording start-time: 1:37:15External Link Disclaimer) - Food Safety-Risk Communications
Howard Seltzer (Recording start-time: 3:27:05External Link Disclaimer) - FDA’s Role in the Safety Assessment and Regulation of Food Ingredients
Karen Hall, MA (Recording start-time: 2:38:15External Link Disclaimer) - Cosmetics
Lia (Xylia) Ajose, MBS (Recording start-time: 3:5:05External Link Disclaimer) - Veterinary Products
Diane Heinz, DVM, MBA (Recording start-time: 3:43:45External Link Disclaimer) - New Animal Drug Approval Process
John Merson, MS (Recording start-time: 4:29:51External Link Disclaimer) - Programs for Minor Uses and Minor Species
Jeffery Stuart, DVM, MS (Recording start-time: 5:19:22External Link Disclaimer) - Center for Veterinary Medicine Surveillance and Compliance
Kate Collins, JD (Recording start-time 4:48:45External Link Disclaimer)
4. FDA's food and veterinary medicines responsibilities
- Day 3 Summary and Overview of Day 4
Sharron Watson, Training Specialist, OSPD (Recording start-time: 0:00:00External Link Disclaimer) - Office of Global Policy and Strategy (OGPS) Overview
Karen Riley, MPH (Recording start-time 3:38External Link Disclaimer) - Criminal Investigations
Scott Schillinger (Recording start-time: 55:26External Link Disclaimer) - Compliance and Enforcement Operations
Catherine Beer, MS; Jessica Kocian, MPH; Sherrie Krolczyk (Recording start-time: 1:27:50External Link Disclaimer) - CDER Compliance
Jill Furman, JD (Recording start-time: 2:24:58External Link Disclaimer) - Our Borders and Beyond – Imports and Foreign Operations
Amanda Pasternak, BS and Susan Shaffer, REHS/RS (Recording start time: 3:11:48External Link Disclaimer)
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: 3:30External Link Disclaimer) - Criminal Investigations
SA Jonathan Frick (Recording start- time: 56:52External Link Disclaimer) - Compliance and Enforcement Operations
Catherine Beer, MS; Jessica Kocian, MPH; Sherrie Krolczyk (Recording start-time: 1:28:05External Link Disclaimer) - CDER Compliance
Michael Levy (Recording start-time: 2:23:59External Link Disclaimer) - Our Borders and Beyond – Imports and Foreign Operations
Debra Yamane, Amanda Pasternak (Recording start-time: 3:11:36External Link Disclaimer)
6. FDA regulatory research
- Toxicological Research
Rajesh Nayak (Recording start-time: 0:1:36External Link Disclaimer) - Drug Research
Ruth Barratt, PhD, DVM (Recording start-time: 0:29:10External Link Disclaimer) - Device Research
Edward Margerrison, PhD (Recording start-time 0:55:30External Link Disclaimer) - Food Safety Research
Diane Hao (Recording start-time: 1:41:22External Link Disclaimer) - Veterinary Research
Michael Myers, PhD (Recording start-time: 2:11:40External Link Disclaimer) - ORA Science
Evgeny Kiselev, PhD (Recording start-time: 2:58:40External Link Disclaimer) - Biologics Research
Karen Elkins, PhD (Recording start-time: 3:57:18External Link Disclaimer) - Regulation of Intentionally Altered Genomic DNA in Animals at FDA
Evgenij A. Evdokimov, MS, PhD (Recording start-time: 4:13:37External Link Disclaimer) - CTP’s Tobacco Regulatory Research Program
CAPT Robin Toblin (Recording start-time: 4:43:55External Link Disclaimer)