FDA’s Center for Drug Evaluation and Research (CDER) is sponsoring a daylong public workshop on March 31, 2016, titled Navigating CDER: What You Should Know for Effective Engagement. Our presentations will help patient advocates gain a better understanding of FDA and provide specific resources to help you and your colleagues learn ways to effectively advocate and engage with the Agency on behalf of the patients you serve.
We’ll provide a broad overview of patient engagement with various offices within CDER, and drill down into key specifics such as:
- Who and when to call;
- How to set up a meeting at FDA;
- Provide tips on making the most out of your meeting; and,
- How to prepare an effective presentation for FDA staff.
We’ll also discuss topics such as understanding labeling, generic drugs, and how patients can effectively interact and provide input to FDA. And, we’ll look at some programs including different drug approval processes, expanded access, and FDA’s role in patient focused drug development (PFDD).
These are only a few of the many important areas we’ll tackle.