Search Results for Product-Specific Guidance

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Updated: FDA Releases Flurry of New, Revised Drug-Specific Guidance Documents By Zachary Brennan - Published 19 October 2017

The US Food and Drug Administration (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).

Categories: News, US, CDER, Drugs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: FDA guidance, product-specific guidance, generic drug guidance

FDA Issues New and Revised Guidance for Generic Drugs By Michael Mezher - Published 16 May 2017

The US Food and Drug Administration (FDA) on Tuesday released a batch of 21 new and 16 revised draft guidances intended to help drugmakers conduct the studies needed to support the approval of certain generic drugs.

Categories: News, US, FDA, Clinical, Generic drugs, Submission and registration

Tags: Product-Specific Guidance, Bioequivalence