FDA releases flurry of new, revised drug-specific guidance documents

RAPS

19 October 2017 - The US FDA on Thursday released new draft guidances for 32 drugs, including for those companies looking to develop generic versions of Mylan’s EpiPen (epinephrine) alternative Adrenaclick, Novartis’ cancer treatment Afinitor (everolimus) and AstraZeneca’s cancer treatment Lynparza (olaparib).

On top of the new drafts, FDA released 19 revised guidance documents, including one for companies looking to develop generics of Eli Lilly’s erectile dysfunction drug Cialis (tadalafil) and other glaucoma treatments and antibiotics, among others.

Both the new draft and revised guidance documents are part of FDA’s efforts to provide product-specific recommendations on, among other things, the design of bioequivalence studies to support abbreviated new drug applications.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation , Guidelines