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The FDA and Feasible Alternative Designs

Drug & Device Law

Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations. 2003), aff’d , 810 N.Y.S.2d 7, 2022), which addressed the same question in the context of the admissibility of expert testimony.

FDA 59