Search Results for generic drug guidance

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FDA Targets Multiple Review Cycles With New Draft Guidance, MAPP By Zachary Brennan - Published 03 January 2018

Fresh out of a record year for generic drug approvals, the US Food and Drug Administration (FDA) on Wednesday kicked off the new year by releasing new draft guidance and a new manual of policies and procedures (MAPP) with an eye toward decreasing the number of review cycles abbreviated new drug applications (ANDAs) undergo before approval.

Categories: News, US, FDA, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: ANDA review cycles, generic drug guidance, MAPP

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 Offers New Bioequivalence Recommendations for 31 Active Ingredients, 13 Revisions By Zachary Brennan - Published 22 December 2016

The US Food and Drug Administration (FDA) on Thursday announced the latest batch of new draft guidance for the generic drug industry on 31 product-specific bioequivalence (BE) recommendations and 13 revisions to prior recommendations.

Categories: News, US, FDA, Active pharmaceutical ingredients

Tags: BE studies, generic drug guidance from FDA, active ingredients

Generic Topical Patches: FDA Offers Draft Guidance on Adhesion Studies By Zachary Brennan - Published 31 May 2016

Generic drugmakers submitting clinical studies on the adhesive performance of a transdermal delivery system (TDS) or topical patch will want to take note of new draft guidance released Tuesday from the US Food and Drug Administration (FDA).

Categories: News, US, CDER, Clinical, Generic drugs, Quality

Tags: drug patch adhesion, generic drug guidance, clinical study design guidance