Join us to learn the essentials of drug law and how to engage with FDA to better support your organization’s advocacy efforts.

For this two-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
  • Implementation of 21st Century Cures
  • Interacting with Drug Development Enterprise & FDA

Individuals working for patient organizations in the non-profit sector are eligible to participate in the program. Applicants will be accepted on a case by case basis, and participation is limited to 5 Individuals per organization. Attendees speaking at the course do not count towards an organization’s total number of attendees. Registration for this full-day program is only $49.



subject to change

Curriculum Advisor:
Mahnu Davar, Arnold & Porter LLP

Wednesday, November 7

10:30 AM

11:00 – 11:05 AM
Welcome and Announcements
Amy Comstock Rick
, President & CEO, FDLI
Brenda Huneycutt
, Director, FasterCures

11:05 – 11:50 AM
Introduction to FDA
Jason W. Sapsin
, Counsel, Fagre Baker Daniels

  • The U.S. Drug Regulatory Process 
  • FDA Organization  
  • Types of FDA Regulatory Requirements and Pronouncements 
  • 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
Engaging with FDA: Opportunities and Boundaries 

  • FDA’s Patient Engagement Offices 
  • FDA’s Patient Engagement Programs 
  • Participating in FDA Policymaking 
  • Draft Guidance on Patient-Focused Drug Development  

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

  • 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
Mahnu Davar
, Partner, Arnold & Porter

  • 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

5:30 PM

Thursday, November 8

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

  • Expanded Access 
  • Federal Right-to-Try Legislation and Affect on Current FDA Expanded Access Frame Work

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 
  • Product Quality Considerations
  • Unapproved Uses of Drugs

11:00 – 11:15 AM 
Refreshment Break

11:15 –12:15 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)
  • Biosimilars: Intersection of Regulatory Exclusivity and Patent Exclusivity

12:15  – 1:15 PM

1:15 – 2:15 PM 
Stakeholder Interactions in the Drug Development Community 

  • Sponsor-patient group engagement
  • Payor Communications Post-Cures Act

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