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US FDA Drug Office Reform: 'Everything' Is On The Table

 
• By Derrick Gingery

Deputy Office of New Drugs director says IND evaluation and post-market surveillance could be part of restructuring effort along with changes to application review.

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The US FDA's restructuring of the Office of New Drugs could extend well beyond new drug application reviews. Changes to many of its pre- and post-market business practices also are being considered.

Peter Stein, deputy OND director, said "we put everything on the table" as the office in charge of review and...

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