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 – Rokhsareh Shahidzadeh, MSN, RN
(Recording: start-time: 0:00) - Office of Clinical Policy and Programs Overview – Stephanie Shapley
(Recording: start-time: 10:18) - Office of Orphan Products Development (OOPD) Overview – Erika Torjusen, MD
(Recording: start-time: 49:19)
2. FDA's regulatory framework
- FDA’s Regulatory Framework – Robert Berlin, JD, MPH
(Recording: start-time: 1:15:59) - Drug Regulation – Mathew Thomas
(Recording: start-time: 1:47:22) - Device Regulation – Jonette Foy, PhD
(Recording: start-time: 2:16:29) - A Brief History Of Biological Product Regulation – Mustafa Unlu, PhD, JD
(Recording: start-time: 10:19) - U.S. Food Safety System Overview – Eric L. Stevens, PhD
(Recording: start-time: 40:02) - Overview of the Family Smoking and Prevention And Tobacco Control Act – Lauren Belcher, JD
(Recording: start-time: 1:12:28) - Product Classification and Jurisdiction – Diana Yoon, PhD
(Recording: start-time: 2:05:46) - Overview of FDA Office of Legislation – Yasemin Luebke
(Recording: start-time: 2:52:02)
3. FDA's medical product and tobacco responsibilities
- Overview of Drug Development and FDA Review – Mark Hirsh, MD
(Recording: start-time: 0:00) - Pre-IND and IND Review Process – Callie CappelLynch, Pharm.D, RAC
(Recording: start-time: 55:45) - CDER Review Process for Marketing Applications – Lara Akinsanya, MS
(Recording: start-time: 1:52:24) - Overview of Medical Device Regulation – Marjorie Shulman, MBA
(Recording: start-time: 2:46:46) - Generic Drugs 101 – LCDR Yen Anh Bui, PharmD
(Recording: start-time: 5:25) - Electronic Product Radiation Control: Law and Regulations – Daniel Kassiday
(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 - Andrew Harmon
(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) - Overview of the Office of Surveillance and Epidemiology – Darrell Lyons
(Recording: start-time: 0:54) - Post Marketing Surveillance & Signal Management at CDRH – Ron Yustein, MD
(Recording: start-time: 30:09) - Tobacco Compliance and Enforcement - Laurie Sternberg
(Recording: start-time: 1:01:30) - Office of Minority Health and Health Equity – Cariny Nunez
(Recording: start-time: 1:36:43)
4. FDA's food and veterinary medicines responsibilities
- Food Safety - Risk Assessment and Identifying, Obtaining and Using Science to Make Food Safety Decisions – Yuhuan Chen, PhD
(Recording: start-time: 2:11:59) - FDA’s Food Safety Inspection System & FDA Recalls and Seizure Activities – Asha Dwarka
(Recording: start-time: 2:57:00) - Food Safety - Risk Communication - Howard Seltzer
(Recording: start-time: 0:00) - FDA’s Role in the Regulation and Safety Assessment of Food Ingredients - Carrie McMahon, PhD
(Recording: start-time: 37:13) - Cosmetics 101 - Jo Huang, PhD
(Recording start-time: 1:05:57) - Center for Veterinary Medicine (CVM) – Diane Heinz
(Recording: start-time: 1:38:08) - New Animal Drug Approval Process – Youssef “Joe” Zinoun, MBA
(Recording: start-time: 2:26:18) - Programs for Minor Uses and Minor Species – Margaret Oeller
(Recording: start-time: 3:02:53) - Center for Veterinary Medicine Office of Surveillance and Compliance: An Overview – Kate Collins, JD
(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) - Drug Research - Ruth Barratt, PhD, DVM
(Recording: start-time: 41:58) - Our Borders and Beyond – Imports and Foreign Operations - John Verbeten
(Recording: start-time: 1:16:04) - Office of Criminal Investigations: 101 - Gregory Williams
(Recording: start-time: 2:15:59) - Compliance and Enforcement Operations – Scott MacIntire
(Recording: start-time: 3:36:14) - District/Program Division Responsibilities - Evelyn Bonnin
(Recording: start-time: 4:01:34) - 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) - Office of Women’s Health – Bridget Nugent, PhD
(Recording: start-time: 37:10) - CDRH - Ed Margerrison, PhD
(Recording; start-time: 59:26) - Food Safety Research - Karen R. Hatwell, PhD
(Recording: start-time: 2:06:15) - Veterinary Research - Michael J. Myers, PhD
(Recording: start-time: 3:31:27) - Office of Regulatory Affairs (ORA) Science - Ken Yoshitomi, 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 - Dana van Bemmel, PhD, MPH
(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)