Case Studies In FDA's Regulatory Interpretation Of Clinical Trials
For more than 15 years, the Pink Sheet's Drug Review Profile series has looked closely at FDA approval documents, providing a long view of the pitfalls and pitches presented in the NEJM series on interpreting clinical trial results.
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Determining the success or failure of a randomized trial requires looking beyond the p-value for the primary endpoint, review articles in The New England Journal of Medicine urge.
Testimony from patients about the cosmetic and psychological advantages of seeing melanoma lesions shrink was a key element in agency's decision to offer full approval to Amgen's talimogene laherparepvec despite serious concerns about the clinical meaning of the pivotal trial's durable response rate endpoint.
FDA shoehorned third-line multiple myeloma therapy into accelerated approval program using loophole in concept of unmet medical need; maneuver also gave agency ability to define a do-over of development plan.