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Got a New Drug Approval in 2025? Some Food for Thought.
FDA Great Room - Venue for FDA AdComms There has not been a single FDA Advisory Committee meeting held by the agency nor has one been...
Mark Senak
Mar 254 min read
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FDA's OPDP Posts First Enforcement Letter of 2025
OPDP Enforcement Letters By Year With the communications freeze put into place by the administration, FDA has been relatively quiet....
Mark Senak
Mar 52 min read
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Not Exactly Spare Change - Assessing FDA in a New Era
It is an understatement to say that there has been a tidal wave of change with the inauguration of a new administration and with incoming...
Mark Senak
Feb 143 min read
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What's In Store for FDA AdComms in 2025?
There are a number of issues at play that may tell us some things to look for respecting AdComms in 2025
Mark Senak
Jan 133 min read
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