Regulatory Focus™ > News Articles > CDER Releases List of Upcoming Guidance Documents

CDER Releases List of Upcoming Guidance Documents

Posted 06 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) released 5 March a list of all new and revised guidance documents that the agency plans to release during 2012.

The list contains guidance documents related to:

  • advertising
  • biopharmaceuticals
  • biosimilarity
  • chemistry
  • clinical/antimicrobial
  • clinical pharmacology
  • clinical/statistical
  • combination products
  • current good manufacturing practices/compliance
  • drug safety information
  • electronic submissions
  • Investigational new drugs
  • labeling and procedures.



Read more:

Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2012

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