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Another Reason Why The FDA, Not Litigants, Approves Products

Drug & Device Law

Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. See Health Services Research & Managerial Epidemiology retraction notice, available here. Longbons T., Buckman Co.

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The FDA and Feasible Alternative Designs

Drug & Device Law

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

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