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FDA Week - 04/13/2018

But McClellan praises guidance . . .

Attorney: FDA Guide On Pregnant Women In Trials Lacks 'Carrots & Sticks'

April 12, 2018
FDA took a first step toward encouraging drug companies to enroll pregnant women in clinical trials by putting out a draft guidance that floats scientific and ethical criteria to guide such enrollment. While an industry lawyer suggests formal market incentives and requirements may be needed before drug makers act expeditiously, former FDA Commissioner Mark McClellan argues that there are ways to motivate drug makers to include pregnant women that do not require such a "big lift" of legislation. The draft...


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