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      Authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; issues and crisis management. Frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!

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    • Eye on FDA is published by Mark Senak of Fleishman-Hillard's Washington, D.C. office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of Fleishman-Hillard or its clients.

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    « Weekly Roundup - 03/30/07 | Main | Ketek, Testimony and a Growing Mess »

    April 02, 2007

    A Conversation with the FDA Associate Commissioner for Public Affairs

    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. 

    Logo5c 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.

    Need to know more about podcasts?  Click here.

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