Search Results for CRLs

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Elemental Impurities Deadline Contributes to Spike in CRLs for Generic Drugmakers By Zachary Brennan - Published 19 January 2018

New generic drug applications are not winning a lot of approvals from the US Food and Drug Administration (FDA) so far this year and at least part of the reason for the increase in complete response letters (CRLs) is a new requirement from the US Pharmacopeia (USP).

Categories: News, US, FDA, Generic drugs

Tags: generic drugs, CRLs

FDA to Begin Issuing Deficiency Review Letters to Generic Drugmakers By Zachary Brennan - Published 15 December 2017

The US Food and Drug Administration (FDA) on Friday published draft guidance that would establish a new type of letter the agency sends to generic drugmakers to provide applicants with preliminary thoughts on possible deficiencies of an abbreviated new drug application (ANDA).

Categories: News, US, FDA, Compliance, Generic drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: DRLs, CRLs, information requests, GDUFA II

FDA Transparency: Agency’s Hands Tied by its own Regulations By Zachary Brennan - Published 15 March 2017

Ask a US Food and Drug Administration (FDA) official how many biosimilar applications are actually under review, or the details of a recent Complete Response Letter (CRL), and he or she will explain how the agency cannot offer any more details than what is already publicly known, even if what has been made public is not aligned with reality.

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: FDA transparency, CRLs, biosimilars

FDA Rejects Highest Number of Monthly Generic Drug Applications Ever By Zachary Brennan - Published 08 June 2016

The common refrain that the US Food and Drug Administration (FDA) has been approving an exorbitantly high number of drug applications for generic drugs, known as abbreviated new drug applications (ANDAs), to increase market competition in recent years is slowing down in recent months.

Categories: News, US, FDA, Compliance, Generic drugs, Government affairs, Quality

Tags: ANDA approvals, complete response letters, CRLs, generic drug applications