2001 FDA Approval Regulations Testimonials 
Drug & Device Law
FEBRUARY 11, 2024
FDA litigation that is now before the Supreme Court. 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. We were hardly alone. See AHM I , 2023 WL 2825871, at *4 n.9
Drug & Device Law
FEBRUARY 20, 2023
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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