Search Results for CRLs

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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