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: 00:00) - Office of Clinical Policy and Programs Overview, Patient Affairs, and Good Clinical Practice
Jessica Cades PhD (Recording start-time: 10:00) - Patient Affairs: The FDA’s Front Door
Carmen Matos (Recording start-time: 15:28) - Office of Combination Products, Product Classification & Jurisdiction
Ifeanyi Uwemedimo, PhD (Recording start-time: 34:59) - Office of Orphan Products Development, Rare Pediatric Diseases, and Grants Programs
Erika Torjusen, MD, MHS (Recording start-time: 52:55) - Office of Pediatric Therapeutics
Melanie Bhatnagar (Recording start-time: 1:10:02)
2. FDA's regulatory framework
- FDA’s Regulatory Framework
Lauren Roth (Recording start-time: 1:35:30) - Drug Regulation
Kavita Dada, PharmD, RAC (Recording start-time: 2:17:00) - Device Regulation
Ariel Seeley (Recording start-time: 2:39:39) - A Brief History Of Biological Product Regulation
Mustafa Unlu (Recording start-time: 3:19:28) - U.S. Food Safety System Overview
Kelly McCormick (Recording start-time: 3:55:48) - Overview of the Family Smoking and Prevention And Tobacco Control Act
Adriran Mixon, JD (Recording start-time: 4:21:31) - FDA and the Legislative Branch
Paul Aguilar (Recording start-time: 4:37:33) - The Office of Women’s Health Overview
Erin South, PharmD (Recording 2, start-time: 12:39) - Overview of FDA’s One Health Initiative
Brianna Skinner, DVM, MPH, DACLAM CAPT. USPHS (Recording 2, start-time: 37:21)
3. FDA's medical product and tobacco responsibilities
- Day 2 Summary and Overview of Day 3
Sharron Watson, Training Specialist, OSPD (Recording start-time 0:00:00) - Post Marketing Activities
Phuong B. Nguyen, RPh, GWCPM, CQIA
Barbrakaryne Nchinda Fobi, PharmD, MPH
Amy Chen, Pharm D (Recording start-time: 00:51) - Device Post Marketing Activities
Carrie Voycheck, PhD (Recording start-time: 25:01) - Tobacco Compliance and Enforcement
Loretta Chi, JD (Recording start-time: 2:08:10) - Office of Minority Health and Health Equity
Anthony Welch, BA (Recording start-time: 54:30) - Food Safety - Risk Assessment and Identifying, Obtaining and Using Science to Make Food Safety Decisions
D Sarah Murphy, PhD (Recording start-time: 1:10:50) - Food Safety – Inspections, Seizures and Recalls
Nicholas Long (Recording start-time: 1:37:15) - Food Safety-Risk Communications
Howard Seltzer (Recording start-time: 3:27:05) - FDA’s Role in the Safety Assessment and Regulation of Food Ingredients
Karen Hall, MA (Recording start-time: 2:38:15) - Cosmetics
Lia (Xylia) Ajose, MBS (Recording start-time: 3:5:05) - Veterinary Products
Diane Heinz, DVM, MBA (Recording start-time: 3:43:45) - New Animal Drug Approval Process
John Merson, MS (Recording start-time: 4:29:51) - Programs for Minor Uses and Minor Species
Jeffery Stuart, DVM, MS (Recording start-time: 5:19:22) - Center for Veterinary Medicine Surveillance and Compliance
Kate Collins, JD (Recording start-time 4:48:45)
4. FDA's food and veterinary medicines responsibilities
- Day 3 Summary and Overview of Day 4
Sharron Watson, Training Specialist, OSPD (Recording start-time: 0:00:00) - Office of Global Policy and Strategy (OGPS) Overview
Karen Riley, MPH (Recording start-time 3:38) - Criminal Investigations
Scott Schillinger (Recording start-time: 55:26) - Compliance and Enforcement Operations
Catherine Beer, MS; Jessica Kocian, MPH; Sherrie Krolczyk (Recording start-time: 1:27:50) - CDER Compliance
Jill Furman, JD (Recording start-time: 2:24:58) - Our Borders and Beyond – Imports and Foreign Operations
Amanda Pasternak, BS and Susan Shaffer, REHS/RS (Recording start time: 3:11:48)
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: 3:30) - Criminal Investigations
SA Jonathan Frick (Recording start- time: 56:52) - Compliance and Enforcement Operations
Catherine Beer, MS; Jessica Kocian, MPH; Sherrie Krolczyk (Recording start-time: 1:28:05) - CDER Compliance
Michael Levy (Recording start-time: 2:23:59) - Our Borders and Beyond – Imports and Foreign Operations
Debra Yamane, Amanda Pasternak (Recording start-time: 3:11:36)
6. FDA regulatory research
- Toxicological Research
Rajesh Nayak (Recording start-time: 0:1:36) - Drug Research
Ruth Barratt, PhD, DVM (Recording start-time: 0:29:10) - Device Research
Edward Margerrison, PhD (Recording start-time 0:55:30) - Food Safety Research
Diane Hao (Recording start-time: 1:41:22) - Veterinary Research
Michael Myers, PhD (Recording start-time: 2:11:40) - ORA Science
Evgeny Kiselev, PhD (Recording start-time: 2:58:40) - Biologics Research
Karen Elkins, PhD (Recording start-time: 3:57:18) - Regulation of Intentionally Altered Genomic DNA in Animals at FDA
Evgenij A. Evdokimov, MS, PhD (Recording start-time: 4:13:37) - CTP’s Tobacco Regulatory Research Program
CAPT Robin Toblin (Recording start-time: 4:43:55)
