An organization with a robust quality system will have established policies and procedures, so it should be no surprise that CDER has a full set. By law, these must be available to the public, so they have been published on the CDER website as the CDER Manual of Policies and Procedures (MAPP). A review of the list shows many of the individual MAPP documents cover administrative issues ( ). If you take a closer look, you’ll find that many documents can be very useful for sponsors of INDs, NDAs, BLAs, and ANDAs. For example, sponsors may benefit from understanding the CDER process for review and may consider
- 5016.1 – Applying ICH Q8(R2), Q9, and Q10 Principles to CMC Review,
- 5210.4 Rev. 2 – Review of Bioequivalence Studies with Clinical Endpoints in ANDA,
- 6010.3 Rev. 1 – Good Review Practice – Clinical Review Template, or
- 6030.1 Rev. 3 – IND Process and Review Procedures ( Including Clinical Holds)
The Compliance program has its own set of policies and procedures, which we’ll discuss in the next post.
Reach out to me if you want to know more or discuss your medical product development challenges.
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Text Copyright © 2020 Katrina Rogers