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The FDA and Feasible Alternative Designs

Drug & Device Law

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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On Expert “Adulteration” and “Misbranding” Opinions

Drug & Device Law

A lot of the discussion in Tsao was case specific because the purported expert opinions at issue were among the most ridiculous we’ve ever seen – directly contrary to the controlling FDA regulations applicable to the particular drug. Rather, expert testimony couched as legal conclusion merely tells the jury which result to reach.