Whither FDA’s drug approval paradigm? — A Debate from Recent FDA Law SSRN Postings

A series of thoughtful articles in the spring tackled some basic questions about the drug development and approval paradigm.  I’ll be reviewing other SSRN postings in later posts, but the articles described below work well together — presenting fundamental questions about how drugs should be studied (when and by whom), how the resulting information is processed, and what information (how much and what type) should be required before drugs are permitted on the market.  And they tee up what might be a spirited debate about what, exactly, a “public health” approach to new drug approval might mean.

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