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BLA 125400

 

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.

 
 

   
 
