dshah
★★  

India/United Kingdom,
2024-03-26 18:15
(16 d 22:24 ago)

Posting: # 23923
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 Handling and Retention of BA and BE Testing Samples [BE/BA News]

Hi All!

FDA had published the draft guideline on: Handling and Retention of BA and BE Testing Samples.

The guidance highlights:
  • how the test article (T) and reference standard (RS) for BA and BE studies should be distributed to the testing sites,
  • how testing sites should randomly select samples for testing and material to maintain as reserve samples,
  • how the reserve samples should be retained,
  • and clarifying recommendations related to certain other relevant requirements.
    The guidance updates:
  • the agency’s expectations for study sponsors and/or drug manufacturers, CROs, SMOs, and clinical investigators around the handling and retention of BA and BE testing samples
  • and the agency’s previously issued Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) guidance (August 2020) to further reduce the quantity of reserve samples to be retained. This updated compliance policy is for immediate implementation.

Regards,
Divyen
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