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

For this two-day virtual 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, and there will be ample opportunity to get your questions answered. Ahead of the live course, complete the ProgressForPatients.org Advocacy Education Program for background information and to prepare for the live sessions.

Agenda Highlights Include:

  • Expedited Pathways
  • Incorporating Patient Experience into Drug Development and FDA Policy
  • Overview of Cell and Gene Therapies
  • Patient Access to Treatments, Other Agencies, and Lawmakers
  • Engagement Opportunities with FDA Offices
  • Lessons Learned from COVID-19
  • Hot Topics to Stay Up-to-Date



This course is offered at a discounted rate of $49 for staff and volunteers of 501(c)(3) patient or disease organizations. Applications are considered on a case-by-case basis.


Sponsorship opportunities are available. Please let us know if you would like more information.

A special thanks to the FDLI Patient Organization Engagement Committee:

Mitchell Berger, FDA–CBER
Ryan Hohman, Friends of Cancer Research
Katherine Maynard, Peterson Wilmarth and Robertson, LLP (PWR)
Peter Pitts, Center for Medicine in the Public Interest
Jodi Schipper, FDA–OC
Deborah Shelton, ACPMP
Kathryn Spates, National Institutes of Health
James E. Valentine, Hyman, Phelps & McNamara, PC
David Zook, Faegre Drinker Biddle & Reath LLP