Search Results for complex generics

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GAO to FDA: Publish Plans to Issue or Revise Guidance on Complex Generic Drugs By Zachary Brennan - Published 16 January 2018

The US Government Accountability Office (GAO) on Tuesday called on the US Food and Drug Administration (FDA) to announce plans to issue or revise guidance for complex generic drugs and FDA said it agrees with the recommendation and is working toward that goal.

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

Tags: complex generics, GAO report

Gottlieb: More Guidance on Complex Generics Coming By Zachary Brennan - Published 28 November 2017

The US Food and Drug Administration’s (FDA) difficulties in approving generic versions of complex products were front and center in Commissioner Scott Gottlieb’s comments at FDA’s Generic Drug Science Day on Tuesday.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: complex generics, Copaxone, Advair, EpiPen

House Panel Calls on GAO to Study FDA’s Approval Pathway for Complex Generics By Zachary Brennan - Published 15 December 2015

Chairman of the House Committee on Energy & Commerce Fred Upton (R-MI), ranking member Frank Pallone (D-NJ) and other representatives on both sides of the aisle are calling on the Government Accountability Office (GAO) to assess the US Food and Drug Administration’s (FDA) approval pathway for generic drugs that have complex active pharmaceutical ingredients (APIs).

Categories: News, US, FDA, Active pharmaceutical ingredients, Compliance, Crisis management, Drugs, Government affairs, Regulatory strategy, Submission and registration

Tags: GAO, complex generics, APIs, FDA ANDA approvals