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Vaccines, Blood & Biologics
CBER Clinical Reviewer: Agnes Lim, M.D.
Re: The original BLA submission did not include a pharmacovigilance plan (PVP). At FDA’s request, the Applicant has submitted a PVP for this BLA (submission#1)
Summary of PVP:
The Applicant has submitted a detailed pharmacovigilance plan, following ICH E2E PVP guidance. The FDA Office of Biostatistics and Epidemiology (OBE) has determined that the Applicant’s pharmacovigilance plan for Gintuit is acceptable.
Routine pharmacovigilance activities will be conducted by the Applicant’s regulatory Affairs and Medical Affairs Departments under standard operating procedures to determine causality, relationship and severity of an adverse event. Organogenesis will oversee an outside pharmacovigilance contract organization (PVCO) to generate MedWatch forms for each adverse event, maintaining the Gintuit pharmacovigilance database and compiling periodic Safety Update Reports. The PVCO has not been selected yet.