The FDA and Feasible Alternative Designs
Drug & Device Law
FEBRUARY 20, 2023
Drug manufacturers often could trade a little less efficacy for a little more safety, but the safest design is not always the best one. to determine whether a proposed alternative drug would have received FDA approval.” 2003), aff’d , 810 N.Y.S.2d For physicians to prescribe such a safer drug, it must reach the market.
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