Today begins a new era here at Eye on FDA as I am placing on-board my first podcast. This is the beginning of a series of podcasts I am planning that will appear from time-to-time.
On Friday, I had the pleasure of sitting down with Julie Zawisza, Assistant Commissioner for Public Affairs at FDA and we spoke about how to best work with the agency around milestone announcements. She had advice for PR firms, for pharmaceutical companies – both communications and regulatory and for FDA beat reporters.
We covered a lot of ground:
- What factors in to a decision on whether or not the FDA is going to issue a press release around a milestone such as an approval?
- Can companies work with FDA to coordinate an announcement and if so, how?
- Will the media office work with PR firms?
- What is the internal process inside FDA for generating an announcement?
- What, if anything can be done about those pesky Friday night approval announcements?
- Does FDA ever reach out to reporters directly when making an announcement?
- Whatever happened to Talk Papers?
If you have ever wanted to know the answer to any of these questions, I invite you to listen to this interview. I must warn you we covered a lot of material and this is a good 30-minute tutorial, but if you can spare the time, you will most certain learn a great deal about working with the FDA media office.
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