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Introduction to Drug and Device Law and Regulation for Patient Organizations
November 5, 2019 @ 8:00 am - November 6, 2019 @ 5:00 pm EST
Join the Food and Drug Law Institute 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 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 framework and strategies available for interacting with the agency. Case studies will illustrate the opportunities for engagement and legal challenges facing patient organizations, industry, and the FDA.
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