Search Results for guidance agenda

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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(FDA) Center for Drug Evaluation and Research (CDER) on Wednesday released its agenda of new and revised draft guidance documents to be published this calendar year, and it includes several eagerly-awaited documents, such as ones on biosimilar interchangeability (which has been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 Says Nonproprietary Biologics Naming Policy Coming Later This Year Published 29 April 2015

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) plans to release five additional guidance documents by the end of 2015, including one on the nonproprietary names given to biological products, it announced Tuesday.

Categories: News, US, CDER, Biologics and biotechnology, Drugs

Tags: Guidance Agenda, Nonproprietary Name. INN

FDA's Veterinary Regulators Eye Dozens of Policy Changes in 2015 By Alexander Gaffney, RAC - Published 02 February 2015

The US Food and Drug Administration's (FDA) veterinary regulatory division, the Center for Veterinary Medicine (CVM), plans to release 31 new or updated policies in 2015, it has confirmed.

Categories: News, US, FDA, Veterinary products

Tags: CVM, Guidance, Guidance Agenda, 2015 Guidance, Center for Veterinary Medicine

FDA's CBER Announces Plans to Release Guidances on Gay Blood Ban, Ebola and More By Alexander Gaffney, RAC - Published 26 January 2015

The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) plans to release nearly a dozen guidance documents this year, including a massively anticipated document outlining planned changes to its "donor deferral policy" that now prevents most homosexual men from donating blood.

Categories: News, US, CBER, Biologics and biotechnology, Blood

Tags: Guidance Agenda, CBER Guidance Agenda, Ebola, Blood Ban, Donor Deferral Policy, Guidance, Draft Guidance, Final Guidance

FDA Plans to Release 28 Device Guidance Docs in 2015, Including on Software and Diagnostics By Alexander Gaffney, RAC - Published 08 January 2015

The US Food and Drug Administration has just released a list of all medical device guidance documents it plans to release in 2015, including ones related to speeding up device submissions, regulating lab-developed tests (LDTs) and the regulation of decision support software.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices

Tags: Guidance Agenda, 2015 CDRH Guidance Documents

CDER Plans 90 Guidance Documents in 2015, Including on Biosimilarity and Social Media By Alexander Gaffney, RAC - Published 06 January 2015

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has released a new list of 90 guidance documents it plans to publish in 2015, including several long anticipated and eagerly awaited by members of the pharmaceutical industry.

Categories: News, US, CDER, Biologics and biotechnology, Drugs

Tags: Guidance, Guidance Agenda, 2014 Guidance Agenda, Final Guidance, Draft Guidance

FDA's Veterinary Division Plans to Release Dozens of Regulatory Guidances in 2014 By Alexander Gaffney, RAC - Published 23 January 2014

Categories: US, FDA

Tags: Guidance Agenda, Veterinary, CVM, Latest News, guidance

CDRH Lays Out Guidance Development Plans for Current Fiscal Year By Alexander Gaffney, RF News Editor - Published 07 November 2013

Categories: US, FDA, CDRH

Tags: Guidance Agenda, draft guidance, guidance

UPDATED: CDER Agenda Foreshadows Release of Guidances Long Sought by Industry By Alexander Gaffney, RF News Editor - Published 29 July 2013

Categories: FDA, CDER

Tags: Guidance Agenda, List, pharmaceutical, draft guidance, guidance, drug

CDER on Pace to Release 61 New and Revised Guidance Documents in 2012 By Alexander Gaffney - Published 09 August 2012

Categories: CDER

Tags: Guidance Agenda, Latest News, guidance, regulatory