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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. 151, 163-68 (2001)) (lengthy discussion of FDA regulatory process omitted). Wyeth Laboratories, Inc. , 2d 397 (6th Cir.

FDA 59