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          FDA 101: An Overview of FDA's Regulatory Review and Research ActivitiesWhat We Do FDA 101: An Overview of FDA's Regulatory Review and Research Activities
  
  	
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    PrintFDA 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 research1. 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)

Image depicts the full scope of FDA's mission

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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)

Image depicting durgs, devices, biologics, tobacco, and food

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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)

Montage of photos of medicines, CT scan, petri dish, tobacco

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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)

Photo montage of food, cosmetics, drugs

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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)

Photo map of world

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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)

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                                                                                  Content current as of:
      10/02/2023What We Do
 
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