Whether to drop a secondary endpoint that will dominate the AdCom from CMC

Situation

A company with a CMC site change mid-review cannot treat an inspector asking for batch records you cannot produce this week as color commentary on CMC comparability package for a site change. Clinical-development physician must close to drop a secondary from that extract under Pharma & Life Sciences / FDA Response and Labeling.

Decision

Clinical-development physician in a company with a CMC site change mid-review must choose Proceed under protocol / Pause the pathway / Escalate safety review / Hold using CMC comparability package for a site change after an inspector asking for batch records you cannot produce this week.

Hypotheses to test

• Clinical-development physician can defend Proceed under protocol from CMC comparability package for a site change after an inspector asking for batch records you cannot produce this week in a Pharma & Life Sciences challenge.
• Clinical-development physician cannot defend Proceed under protocol from CMC comparability package for a site change; Pause the pathway is what the extract actually supports after an inspector asking for batch records you cannot produce this week.
• An inspector asking for batch records you cannot produce this week never reached the population in CMC comparability package for a site change — reopen intake, do not close to drop a secondary.
• Two facts in CMC comparability package for a site change after an inspector asking for batch records you cannot produce this week conflict for clinical-development physician; hold this FDA Response and Labeling file.

Analysis required

• Trace CMC, labeling, or pharmacovigilance facts in CMC comparability package for a site change after an inspector asking for batch records you cannot produce this week.
• Separate an isolated adverse event from a systemic quality issue.
• Test a protocol deviation versus a safety signal versus a filing gap on to drop a secondary.
• For this Pharma & Life Sciences FDA Response and Labeling file, read CMC comparability package for a site change against an inspector asking for batch records you cannot produce this week and write the one fact that would move to drop a secondary for clinical-development physician.

Recommendation

Choose Proceed under protocol / Pause the pathway / Escalate safety review / Hold on this Pharma & Life Sciences / FDA Response and Labeling packet (CMC comparability package for a site change after an inspector asking for batch records you cannot produce this week). The follow-on FDA Response and Labeling action is what clinical-development physician does next: implement the option, assign an owner, and log the missing fact.