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The FDA and Feasible Alternative Designs

Drug & Device Law

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” 2003), aff’d , 810 N.Y.S.2d For physicians to prescribe such a safer drug, it must reach the market. 2d 397 (6th Cir.

FDA 59
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A Texas Mess

Drug & Device Law

2003); Birdsong v. purchase, marketing, promotion, . . Alabama State Board of Pharmacy , 61 F.4th Okuley’s Pharmacy & Home Medical , N.E.3d development, clinical testing or investigation, distribution, purchase, marketing, promotion, sale, purchase, or use” of an immune covered countermeasure. Ogle , 108 S.W.3d

Vaccine 59
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NPP, DCC, And FDA-Regulated Medical Products

Drug & Device Law

The word “generic” in that sentence was not limiting, as the logic applied more broadly: “Nor could such a state law duty exist, as it would directly conflict with the federal statutory scheme in which Congress vested sole authority with the FDA to determine whether a drug may be marketed in interstate commerce.” Id. Walsh , 538 U.S.