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                FDA Learning Portal for Students, Academia, and Industry

FDA Learning Portal for Students, Academia, and Industry

                        FDA Education and Resources by Subject
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          FDA Learning Portal for Students, Academia, and Industry
          FDA Education and Resources by SubjectFDA Learning Portal for Students, Academia, and Industry FDA Education and Resources by Subject
  
  	
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Overview of FDA
	FDA’s Organization
	FDA’s Regulatory Framework
	Current Initiatives**Medical Products and Tobacco**

Human Drug Approval and Post-marketing
	Device Approval and Post-marketing
	Radiation emitting Products
	In Vitro Diagnostics
	Biologics (Blood, Vaccines, Cell, Tissue and Gene) Products
	Tobacco Products

**Foods and Veterinary Medicine**

Foods
	Cosmetics
	Dietary Supplements
	Infant Formulas
	Animal Drugs and Feed**Other Topics**

FDA Research
	Other Training

Overview and General Information



Overview of FDA

**Education**

A Tour of FDA
	FDA Basics for Industry**Resources**

About FDA

FDA's Organization

**Education**

Introduction to the FDA
	Medical Products and Tobacco
	Food Safety and Veterinary Medicine
	Global Regulatory Operations and Policy**Resources**

Commissioner
	Office of the Commissioner
	Office of Medical Products and Tobacco
	Center for Biologics Evaluation and Research
		Center for Drug Evaluation and Research
		Center for Devices and Radiological Health
		Center for Tobacco Products
		Office of Special Medical Programs
		Office of Combination Products
		Office of Good Clinical Practice
		Office of Pediatric Therapeutics
		Office of Orphan Products Development
	Office of Foods and Veterinary Medicine
	Center for Food Safety and Applied Nutrition
		Center for Veterinary Medicine
	Office of Global Regulatory Operations and Policy
	Office of Regulatory Affairs
		Office of International Programs

FDA's Regulatory Framework

**Education**

FDA's Regulatory Framework
	Biologics Products: Laws, Regulations and Guidance
	Device Regulation
	The Past, Present and Future of FDA Human Drug Regulation
	Drug Regulation
	Overview of the Family Smoking and Prevention Act
	Food Safety: International Policy Aspects, Rights and Obligations
	Food Safety Modernization Act
	Veterinary Products**Resources**

Court Cases References
	Laws FDA Enforces

Current Initiatives

Counterterrorism and Emerging Threats
	Globalization
	Health Disparities and Minority Health
	Innovation
	Regulatory Science
	Sentinel Initiative
	Women’s Health

Medical Products and Tobacco

Human Drug Approval and Post-marketing

**Education**

Human Drug Review and Approval
	Clinical Investigator Training
	Electronic Common Technical Document (eCTD)**Generic Drugs**

Generic Drugs
	World of Generic Drugs
	The FDA Process for Approving Generic Drugs
	Guidance Webinars**New Drugs**

New Drugs
	Phases of Drug Review Process
	Pre-IND and IND Review Process
	NDA/BLA Review Process**Over the Counter Drugs**

Over the Counter Drugs**Prescription Adversting, Promotion and Labeling**

Prescription Drug Advertising and Promotion
	Prescription Drug Labeling**Post-Marketing, Compliance and Safety**

Compliance
	Drug Safety
	Field Investigators: Adverse Drug Effects
	Post Marketing Activities**Risk Assessment, Evaluation, Management and Communication**

Risk Assessment and Communication
	Risk Evaluation and Mitigation Strategies: An Introduction for Physicians, Nurses and Pharmacists
	Introducing the REMS Program for the Transmucosal Immediate-Release Fentanyl Products**Small Business and Industry Assistance**

Small Business and Industry Education Series
	Small Business Workshops and Webinars**Other Education**

Adverse Drug Reaction to a Drug: How to Report to FDA’s MedWatch
	Adverse Drug Event Case Report
	Medical Product Safety - MedWatch
	Transforming a Clinician Into an Investigator; What does it Take?**Resources**

Advisory Committees
	Clinical Trials and Human Subject Protection
	Compounding
	Drugs Development and Approval Process
	Generic Drugs
	Guidances
	Guidance, Compliance and Regulatory Information
	How Drugs are Developed and Approved
	Information for industry
	Manufacturing and Product Quality
	Non-prescription Products
	Pediatric Product Development
	Therapeutic Biologics Applications

Device Approval and Post marketing, Radiation Emitting Products and In Vitro Diagnotics

**Education**

Basics of Medical Device Approval and Post-marketing, Radiation Emitting Products and In Vitro Diagnostics
	Clinical Investigator Training
	Medical Device Review at CDRH
	Medical Device Post Marketing Activities
	Medical Device Review at CBER**Resources**

Clinical Trials and Human Subject Protection
	Device Advice
	Guidance Documents
	Importing and Exporting Devices
	Industry Resources
	International Programs
	In Vitro Diagnostics
	IVD Regulation
	Premarket Requirements
	Postmarket Requirements
	Radiation Emitting Products

Biologics Products

**Education**

Blood Regulation
	Cellular, Tissue and Gene Therapies
	Cellular Therapy Products
	Gene Therapies
	CBER’s Regulation of Biologics
	Clinical Investigator Training
	Clinical Trials and Human Subject Protection
	Tissue Regulation
	Vaccine Regulation**Resources**

Advisory Committees
	Allergenics
	Biologics Development & Approval Process at CBER
	Blood and Blood Products
	Blood Establishment Registration and Product Listing
	Cellular and Gene Therapy Products
	Development and Approval Process
	Guidance, Compliance and Regulatory Information
	Information for Industry
	Tissue and Tissue Products
	Tissue Establishment Registration
	Vaccines
	Xenotransplantation

Tobacco Products

**Education**

Tobacco Compliance and Enforcement
	Tobacco Compliance Webinars**Resources**

Advisory Committee
	Guidance, Regulations and Compliance
	Product Requirements, Marketing and Labeling
	Retailer Resources
	Tobacco Resources



Foods and Veterinary Medicine

Foods

**Education**

Food Training Videos
	Food Security Training
	Food Labeling
	Integrated Food Safety System
	National Shellfish Sanitation Program
	Pasteurization
	Pest Control in Food Establishments
	Plumbing Controls for Commercial Establishments
	Shellfish Growing Areas
	Shellfish Plant Sanitation**Resources**

Compliance and Enforcement
	Education Resource Library for Food Safety, Nutrition and Cosmetics
	Food Defense
	Food Safety Modernization Act
	Guidance and Regulation
	Food Industry
	Importing Food Products into the United States
	Information for Industry
	Ingredients, Packaging & Labeling
	Registration of Food Facilities
	Requirements for a Food Business

Cosmetics

**Education**

Current Isssues in the Safety and Labeling of Cosmetics**Resources**

Resources for You on Cosmetics
	Cosmetics Importers & Exporters

Dietary Supplements

**Education**

Regulatory Approaches to Dietary Supplement and their Claims**Resources**

Dietary Supplements
	Dietary Supplements Guidance Documents & Regulatory Information

Infant Formulas

**Resources**

Infant Formula Regulatory Information

Animal Drugs and Feed

**Education**

**Animal Drugs**

Animal Drug Review and Approval Process
	AAVPT Veterinary Drug Regulatory Life Cycle Course
	Advertising Issues, Effectiveness Claims
	Aquaculture
	Bioresearch Monitoring
	Canine NSAIDs and Client Education
	Current Good Manufacturing Practices
	Chemistry, Manufacturing, and Controls and Good Manufacturing Practices: The Big Picture of a Long-Term Commitment
	Effectiveness Evaluation for Therapeutic Drugs for Food Animals
	Effectiveness Evaluation for Therapeutic Drugs for Non-Food Animals
	Effectiveness Evaluation for Production Drugs
	Embracing New Innovation in Veterinary Drug Evaluation
	Environmental Impact (Risk) Assessment of Veterinary Pharmaceuticals
	Foundations of Regulation
	Governance of Veterinary Medicinal Products: Need to Leverage Resources
	Human Food Safety of New Animal Drugs: Microbial Food Safety
	Human Food Safety of New Animal Drugs: Residue Chemistry
	Human Food Safety of New Animal Drugs: Toxicology Assessment
	International Programs Webpage
	Labeling Issues
	Animal Prescription Drug Labeling
	Lifecycle-Based Approach to Regulating Product Quality - An International Perspective
	New Animal Drug Approval Process
	Programs for Minor Uses and Minor Species
	Overview of Minor Use and Minor Species Issues in the U.S.A.
	Principles of New Animal Drug Effectiveness: An Overview
	Recalls
	Regulating Animal Drugs
	Regulation of Animal Biotechnology at FDA: An Overview
	Target Animal Safety**Animal Feed**

AAVPT/CVM Animal Drugs in Feeds Workshop
	FDA and Pet Food
	Helping Animal Producers Understand Medicated Feed Labels
	Medicated Feeds Overview
	Medicated Feed Rules for Animal Feed Manufacturers
	The National Antimicrobial Resistance Monitoring System - Tracking Antimicrobial Resistance in the Food Supply
	Pet Food and Treats in Your Home
	Preventing the Spread for BSE
	Safe Animal Feed**Genetically Engineered Animals**

Regulation of Genetically Engineered Animals at FDA: A Case Study
	Regulation of Genetically Engineered Animals at FDA: A Risk-Based Approach
	Regulation of Genetically Engineered AnimalsResources

Animal Feed
	Animal Drug Development and Approval Process
	Guidance, Compliance and Enforcement
	Guidance for Industry
	Pet Food
	Regulatory Information
	Veterinary Adverse Event Reporting for Manufacturersm
	What You Need to Know: FDA-Approved vs. Unapproved Animal Drugs

Other Topics

FDA Research

Education

Array Track Tutorials
	Biologics Research
	Drug Research
	Device Research
	Food Safety Research
	Office of Minority Health Research
	Office of Women’s Health Research
	ORA Science
	Toxicological Research
	Veterinary Research**Resources**

Animal and Veterinary Science and Research
	Bioinformatics Tools
	Biologics Science and Research
	Cosmetic Science and Research
	Drug Science and Research
	Field Science and Laboratories at ORA
	Food Science and Research
	Medical Device Science and Research
	Tobacco Science and Research
	Toxicological Research at NCTR

Other Training

Communication Skills for Regulators
	ORA Risk Management in 7 Steps
	State, Local and Tribal Regulators

                                                                                  Content current as of:
      09/01/2021FDA Learning Portal for Students, Academia, and Industry

          
                        FDA Education and Resources by Subject
          FDA Education and Resources by FDA Organization
 
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