Join us to learn the essentials of Food and Drug Administration (FDA) law and regulation and the role of patient organizations.

For this one-and-a-half-day program, FDLI brings together law, industry, and FDA experts with deep advocacy experience to equip patient organizations with an understanding of the legal tools and strategies available for interacting with the agency. Case studies will illustrate the opportunities for engagement and legal challenges facing patient organizations.

Agenda Highlights Include:

  • New Drug Development & Clinical Trials Regulation
  • Submission of Marketing Applications & the FDA Approval Process
  • Expanded Access
  • Interacting with Drug Development Enterprise & FDA


Registration for patient organizations and related non-profits will open shortly. The course agenda was specifically designed to equip patient organizations with an understanding of the legal tools and strategies available for interacting with the FDA throughout the drug development process.

Last Year’s Agenda

Day 1

10:30 AM

11:00 – 11:05 AM
Welcome and Announcements

11:05 – 11:50 AM
Introduction to FDA

  • The U.S. Drug Regulatory Process
  • Congressional Oversight

11:50 – 12:30 PM
Beyond FDA: FDA’s Relationship with Other Federal Agencies

12:30 – 1:00 PM

1:00 – 1:45 PM
Hatch-Waxman and Other Statutory Incentives

  • Patent Term Restoration/Extension
  • Five- and Three-Year Exclusivity
  • 180-Day Exclusivity
  • Pediatric Exclusivity
  • Orphan Drugs
  • Priority Review Vouchers (tropical disease, rare pediatric disease, and medical countermeasures) (PRVs)

1:45 – 2:45 PM
Investigational New Drug Application (IND) and New Drug Development

  • What is a “Drug”?
  • What is a “New Drug”?
  • Other-drug like products
  • Who decides whether a product is a “New Drug”?
  • The Investigational New Drug (IND) Process
  • IND Application

2:45 – 3:00 PM
Refreshment Break

3:00 – 4:00 PM
Conduct of Clinical Trials and Human Subjects Protections

  • Clinical Testing/Investigation and “Good Clinical Practice” (GCP)
  • Clinical Trials Registration and Results Reporting (clinicaltrials.gov)
  • Human Subjects Research Protection
  • Bioresearch Monitoring (BIMO)

4:00 – 5:30 PM
Submission of Marketing Applications & the FDA Approval Process

  • Submission & filing of NDAs/BLAs
  • Approval Standards
  • The Review Process
  • Expedited Review
  • Unapproved Uses of Drugs

5:30 PM

Day 2

9:00 – 10:00 AM
Expanded Access to Investigational Therapies

  • Expanded Access
  • State Right-to-Try statutes

10:00 – 11:00 AM
Post-Approval Obligations of Drug Companies

  • Post-Approval (“Phase IV”) Investigations
  • Withdrawal of Approval
  • Annual Reports
  • Adverse Drug Experience (ADE) Reports
  • Post-Approval Changes and Supplemental NDAs (sNDAs) and ANDA’s
  • Grounds for Withdrawal of Approval
  • Sale/Transfer of NDAs/ANDA’s
  • Post-Approval Safety Issues

11:00 – 11:15 AM
Refreshment Break

11:15 –12:15 PM
Stakeholder Interactions in the Drug Development Community

  • Sponsor-patient group engagement
  • Other stakeholders

12:15  – 1:15 PM

1:15 – 2:15 PM
Engaging with FDA: Opportunities and Boundaries

  • FDA’s Patient Engagement Offices
  • FDA’s Patient Engagement Programs
  • Participating in FDA Policymaking

2:15 – 3:00 PM
Question & Answer Panel            

3:00 PM


Milken Institute School of Public Health
At the George Washington University
950 New Hampshire Ave, NW
Washington, DC 20052