Search Results for CDER guidance

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CDER Guidance in 2017: Lots of Procedural and Quality Documents Coming By Zachary Brennan - Published 11 January 2017

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Wednesday released its agenda of new and revised draft guidance documents to be published this calendar year, and it includes several eagerly-awaited documents, such as ones on biosimilar interchangeability (which has been on the list since 2015) and a revision of a draft on postmarket safety reporting for drugs and biologics.

Categories: News, US, CDER, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: interchangeability, FDA guidance, guidance agenda, CDER guidance

FDA’s CDER Unveils Plans for 2016 Guidance Documents By Zachary Brennan - Published 22 January 2016

The guidance agenda for the next fiscal year from the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) reveals a lot of new advice on generics, pharmaceutical quality, off-label communications and other recommendations carried over from 2015, particularly on the implementation of the Drug Supply Chain Security Act (DSCSA).

Categories: News, US, CDER, Advertising and Promotion, Clinical, Drugs, Due Diligence, Labeling, Manufacturing, Postmarket surveillance, Preclinical, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: CDER guidance, 2016 guidance documents, biosimilar guidance