Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Vaccines, Blood & Biologics

Summary of PVP Email, July 21, 2011 - Gintuit


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.

Page Last Updated: 04/03/2012
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English