Whether the 505(b)(2) bridge is legally and scientifically enough from CMC

Situation

Regulatory-affairs lead in a mid-size sponsor after a complete response letter has one working extract — CMC comparability package for a site change — after an inspector asking for batch records you cannot produce this week. If CMC comparability package for a site change cannot support the 505(b)(2) bridge is, the honest Pharma & Life Sciences output is hold.

Decision

Regulatory-affairs lead in a mid-size sponsor after a complete response letter 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

• Regulatory-affairs lead 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.
• Regulatory-affairs lead 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 the 505(b)(2) bridge is.
• Two facts in CMC comparability package for a site change after an inspector asking for batch records you cannot produce this week conflict for regulatory-affairs lead; hold this FDA Response and Labeling file.

Analysis required

• Check whether CMC comparability package for a site change supports the labeled claim regulatory-affairs lead would keep.
• Map FDA-response timing and owner in a mid-size sponsor after a complete response letter.
• 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.
• 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 the 505(b)(2) bridge is for regulatory-affairs lead.

Recommendation