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Regulatory Focus™ > News Articles > CDER on Pace to Release 61 New and Revised Guidance Documents in 2012

CDER on Pace to Release 61 New and Revised Guidance Documents in 2012

Posted 09 August 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has released an updated version of the list of guidance documents it plans to release during 2012, revealing all previously announced guidance remains on track for a 2012 release.

The list, "Guidance Agenda - New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2012," contains 61 guidance documents divided into 16 categories, including advertising, biopharmaceutics, biosimilarity, clinical, combination products, current good manufacturing practices, electronic submissions, labeling and procedures.

Compared to a list of the same name released by CDER in March 2012, it contains no changes. While many of the guidance documents have since been released by the agency, some, including a hotly anticipated guidance on demonstrating biosimilarity using pharmacology data and a host of electronic submission guidances, remain unreleased.


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