A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and ...
Forbes contributors publish independent expert analyses and insights. Fred L. Smith Jr. Fellow at the Competitive Enterprise Institute. The 2024 Federal Register hit 86,712 pages October 30, the third ...
FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" is probably the most used ...
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