Food & Drug Administration Commissioner Peggy Hamburg’s public image for the agency heading into 2012 is clear: FDA is a flexible regulator comfortable making positive new product approval decisions and ready to take an active role in regulatory issues affecting adequate product supply.
FDA “Flexibility” Presages Good Climate in 2012 for Approval Decisions, Shortage Situations
As FDA girds for the Capitol Hill phase of the user fee reauthorization push in 2012, the agency is projecting an image as a flexible problem-solver. FDA’s underlying message: the agency has sufficient authority and does not need tinkering with the legislative mandate. From the drug industry’s perspective, a continued stress on flexibility through the first nine months of the year could create a favorable climate for application reviews and for resolving lingering manufacturing issues.
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