The FDA and Feasible Alternative Designs
Drug & Device Law
FEBRUARY 20, 2023
2003), aff’d , 810 N.Y.S.2d The court in Wolfe refused to impose a negligence duty on the defendant pharmaceutical company to develop and obtain FDA approval of the plaintiff’s non-FDA-approved alternative. In at least the short term, a popular pain reliever would have to be removed from pharmacies. 2d 839, 851 (N.Y. 2006), app.
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