FDA Guidance Document for Preparing Annual Product Reviews

  • Thread starter DeborahBartlett63
  • Start date


I have seen several documents about what should be included in an Annual Product Review (APR); however, I am looking for the FDA Guidance document for the preparation of an APR. I know the requirement is in 211.180e, but as we all know it is very vague.

I would appreciate any help find this or other documents that could help with the preparation of APRs.

Thank you!!
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