Author Archives: Mark Senak

Thumbs Up, Thumbs Down – Minimizing Votes in AdComms

The FDA Commissioner has said he would like to limit votes in AdComms – is that really a good idea? Continue reading

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Big Decisions – Reviewing FDA Advisory Committee Outcomes Since 2020

In January we took a look at FDA Advisory Committees (AdComms) – FDA AdComms – When the Going Gets Tough – noting, among other things that there had not only been fewer meetings but also that it appeared that the … Continue reading

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Emerging from Emergency – Two COVID-Related Developments This Week

Two announcements occurred this week, both of note and connected only by the fact that they are emblematic of the slow metamorphosis from a COVID emergency world to a post-COVID emergency one. Emergency Ends – First, the Biden Administration announced … Continue reading

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What They Said – Looking Back at FDA Press Releases During 2022

Each year Eye on FDA provides a look-back to see what the agency was talking about and what has changed over time. This year is a telling one and FDA may be changing the nature of the way they are … Continue reading

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When the Going Gets Tough – FDA AdComms in 2022

Through its Human Drugs Advisory Committee process FDA has a vast array of outside experts to consult on matters related to product approval as well as questions about policy or safety issues concerning approved products. The mechanism provides an open … Continue reading

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