FDA releases flurry of new, revised drug-specific guidance documents
In an effort to provide support for abbreviated new drug applications, the FDA on Thursday issued a flurry of product-specific recommendations, providing guidance for companies looking to develop generic versions of a number of popular medicines, including Mylan’s EpiPen (epinephrine) alternative Adrenaclick, Novartis’ cancer treatment Afinitor (everolimus) and AstraZeneca’s cancer treatment Lynparza (olaparib).
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