14 May 2012

FDA: Guidelines for requesting waiver to current supported clinical study data standard versions

To request a waiver to submit study data in a retired or unsupported format, sponsors should submit a letter requesting a waiver to CDER-edata@fda.hhs.gov.  The following information should be contained in the request:   
  • Contact person’s name:  this will be the main contact
  • Contact person’s company name
  • Contact person’s mailing address
  • Contact person’s phone number
  • Contact person’s email address
  • Relevant submission types and numbers
  • A description of the submitter’s plan to become compliant with the guidance, including relevant timeframes.
To find more information please use the blow mentioned FDA weblink 


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