By: John J. Whyte, M.D., M.P.H.
So, you and your organization have a passion for helping people and you want to work with FDA to advance your advocacy work. Are you unsure of the most effective way to enable patients to gain greater access to safe and effective drug therapies?
And you can get involved.
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.
For several years, FDA has been working to focus on the needs and goals of the patient as the Agency makes decisions about drug therapies for the advancement and protection of public health. These efforts can only be as effective as our ability to connect with the patients and their representatives we seek to engage.
Join us if you can. If you can’t, we’ll be making information about the meeting available on our website. We look forward to a productive and informative day!
John J. Whyte, M.D., M.P.H., is Director of Professional Affairs and Stakeholder Engagement at FDA’s Center for Drug Evaluation and Research