2020 Introduction to Drug and Device Law and Regulation for Patient Organizations

Event Date: 
Wednesday, November 18, 2020 to Thursday, December 3, 2020
November 18 & 19, December 2 & 3

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

For this multi-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.

Agenda Highlights Include:

  • New Drug Development and Clinical Trials Regulation
  • Submission of Marketing Applications and the FDA Approval Process
  • Expanded Access
  • Implementation of the 21st Century Cures Act
  • New Device Development
  • The 510(k) Process and De Novo Review for Devices
  • Interacting with Drug and Device Development Industries and FDA

Media Contacts

Robert Shalett
Director of Communications 
571-482-2737

We have health challenges in this country that science will provide answers for if given the chance and we haven't given science that opportunity
Mary Woolley, President and CEO, Research!America