Assess whether a CMO finding is a delay or a refuse-to-file risk (1b1424)

Situation

Pharmacovigilance work in a 505(b)(2) program relying on literature plus a bridging study now turns on a CMO finding is because a CMO 483 that maps to the NDA CMC module put disproportionate reporting signal workbook in play. Pharmacovigilance work in a 505(b)(2) program relying on literature plus a bridging study now turns on a CMO finding is because a CMO 483 that maps to the NDA CMC module put disproportionate reporting signal workbook in play; clinical-development physician should say what disproportionate reporting signal workbook proves for Pharma & Life Sciences.

Decision

Clinical-development physician in a 505(b)(2) program relying on literature plus a bridging study must choose A CMO finding is a delay / A refuse-to-file risk using disproportionate reporting signal workbook after a CMO 483 that maps to the NDA CMC module.

Hypotheses to test

• A CMO 483 that maps to the NDA CMC module is noise around an already-controlled Pharmacovigilance process in a 505(b)(2) program relying on literature plus a bridging study, given disproportionate reporting signal workbook.
• A CMO 483 that maps to the NDA CMC module is the event in disproportionate reporting signal workbook that forces A CMO finding is a delay for clinical-development physician under Pharma & Life Sciences.
• Disproportionate reporting signal workbook shows a one-file miss after a CMO 483 that maps to the NDA CMC module, not a Pharmacovigilance program failure.
• Disproportionate reporting signal workbook cannot decide a CMO finding is yet after a CMO 483 that maps to the NDA CMC module; hold is the only Pharma & Life Sciences close a 505(b)(2) program relying on literature plus a bridging study can defend.

Analysis required

• Separate an isolated adverse event from a systemic quality issue.
• Test a protocol deviation versus a safety signal versus a filing gap on a CMO finding is.
• Check whether disproportionate reporting signal workbook supports the labeled claim clinical-development physician would keep.
• For this Pharma & Life Sciences Pharmacovigilance file, read disproportionate reporting signal workbook against a CMO 483 that maps to the NDA CMC module and write the one fact that would move a CMO finding is for clinical-development physician.

Recommendation