ComplianceOnline

Final Guidance on Bioanalytical Method Validation - June 2018

  • By: Staff Editor
  • Date: June 12, 2018
  • Source: https://www.fda.gov
Abstract:

 On May 22, 2018, the US Food and Drug Administration (FDA) published a final guidance for industry entitled "Bioanalytical Method Validation.” This guidance incorporates public comments to the revised draft guidance that was issued in September 2013, and reflects advances in science and technology related to validating bioanalytical methods. 

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