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Items tagged with FDA Files

21CFR312

Updated on 31 December 2011

  • Regulation governing human drug research in the USA before marketing approval
  • Version: Current

21CFR314

Updated on 31 December 2011

  • Requirements for marketing approval in the US for a new drug
  • Version: Current

522 FDA device postmarket surveillance guidance

Updated on 12 January 2012

  • Device Safety Surveillance Guidance from FDA
  • Version: 27 April 2006
Download

FDA draft guidance on reponding to information requests

Updated on 29 December 2011

  • Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices
  • Version: December 2011 draft
Download

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