Assess whether RWE can replace or only supplement an RCT (6eb8dd)

Situation

The Pharmacovigilance desk packet is 505(b)(2) literature-to-product bridge table after an inspector asking for batch records you cannot produce this week. Clinical-development physician in a 505(b)(2) program relying on literature plus a bridging study must name RWE can replace or Only supplement an RCT for this Pharma & Life Sciences file. Clinical-development physician in a 505(b)(2) program relying on literature plus a bridging study has to name RWE can replace or Only supplement an RCT for this Pharma & Life Sciences Pharmacovigilance file.

Decision

Clinical-development physician in a 505(b)(2) program relying on literature plus a bridging study must choose RWE can replace / Only supplement an RCT using 505(b)(2) literature-to-product bridge table after an inspector asking for batch records you cannot produce this week.

Hypotheses to test

• Authorize RWE can replace now; 505(b)(2) literature-to-product bridge table already has the discriminator after an inspector asking for batch records you cannot produce this week.
• Keep Only supplement an RCT in force until 505(b)(2) literature-to-product bridge table is completed after an inspector asking for batch records you cannot produce this week for clinical-development physician.
• Treat 505(b)(2) literature-to-product bridge table as RWE can replace because both readings appear after an inspector asking for batch records you cannot produce this week.
• Refuse a Pharma & Life Sciences close: clinical-development physician does not have the page RWE can replace or turns on in 505(b)(2) literature-to-product bridge table.

Analysis required

• Check whether 505(b)(2) literature-to-product bridge table supports the labeled claim clinical-development physician would keep.
• Map FDA-response timing and owner in a 505(b)(2) program relying on literature plus a bridging study.
• Trace CMC, labeling, or pharmacovigilance facts in 505(b)(2) literature-to-product bridge table after an inspector asking for batch records you cannot produce this week.
• For this Pharma & Life Sciences Pharmacovigilance file, read 505(b)(2) literature-to-product bridge table against an inspector asking for batch records you cannot produce this week and write the one fact that would move RWE can replace or for clinical-development physician.

Recommendation