Center SMG 1213.3 Division of Pharmacovigilance Instruction Manual
- May 15, 2024
- CENTER
Table of Contents
Center SMG 1213.3 Division of Pharmacovigilance Instruction Manual
FDA Staff Manual Guides, Volume I Organizations and Functions
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research Office of Biostatistics and
Pharmacovigilance
Division of Pharmacovigilance
Effective Date: September 30, 2022
1 Division of Pharmacovigilance (DCBDB).
A. Monitors the post-market safety of Center for Biologics Evaluation and
Research (CBER) regulated biological products to inform regulatory decisions.
B. Develops and implements systems for the acquisition of data concerning
clinical experience and use trends of biological products.
C. Develops, maintains, monitors, and analyzes national safety surveillance
databases of adverse events to biological products, including vaccines,
cellular and gene therapies, blood and blood derived products, and tissue
allografts. Coordinates the Center adverse event reporting systems.
D. Performs pharmacovigilance review to assess the adequacy of the
pharmacovigilance plan based on the safety profile data submitted in an
original Biological License Application (BLA) or BLA efficacy supplement as
part of inter-office, interdisciplinary review teams, and provides
recommendations for post-market safety monitoring, post-marketing requirement
(PMR) studies, and Risk Evaluation and Mitigation Strategies (REMS) under the
Food and Drug Administration Amendment Act (FDAAA). Reviews labeling
supplements for safety-related label changes. Reviews the design, evaluates
the implementation and clinical safety data from Phase IV post-marketing
surveillance studies conducted by regulated industry.
E. Performs reviews of other safety data analyses submitted by regulated
industry.
F. Performs comprehensive review of the post-marketing paediatric safety data
to the Paediatric Advisory Committee (PAC).
G. Trains CBER reviewers in the analysis of observational epidemiological
studies and the methods of post-marketing safety surveillance.
H. Serves as the Centre’s representative to national and international working
groups on the reporting of adverse drug reactions and other activities to
assess the risk of biological products.
I. Collaborates with other Center scientists on original research projects,
providing epidemiological and pharmacovigilance input to Center programs.
2 Pharmacovigilance Branch 1 (DCBDB1)
A. Monitors the post-market safety of CBER-regulated biological products to
inform regulatory decisions.
B. Develops, maintains, monitors, and analyses national safety surveillance
databases of adverse events to biological products, including vaccines,
cellular and gene therapies, blood and blood derived products, and tissue
allografts. Coordinates the Center adverse event reporting systems.
C. Performs pharmacovigilance review to assess the adequacy of the
pharmacovigilance plan based on the safety profile data submitted in an
original Biological License Application (BLA) or BLA efficacy supplement as
part of inter-office, interdisciplinary review teams, and provides
recommendations for post-market safety monitoring, post-marketing requirement
(PMR) studies and Risk Evaluation and Mitigation Strategies (REMS) under
FDAAA. Reviews labeling supplements for safety-related label changes. Reviews
the design, evaluates the implementation and clinical safety data from Phase
IV post-marketing surveillance studies conducted by regulated industry.
D. Performs reviews of other safety data analyses submitted by regulated
industry.
3 Pharmacovigilance Branch 2 (DCBDB2)
A. Monitors the post-market safety of CBER-regulated biological products to
inform regulatory decisions.
B. Develops, maintains, monitors, and analyses national safety surveillance
databases of adverse events to biological products, including vaccines,
cellular and gene therapies, blood and blood derived products, and tissue
allografts. Coordinates the Center adverse event reporting systems.
C. Performs pharmacovigilance review to assess the adequacy of the
pharmacovigilance plan based on the safety profile data submitted in an
original Biological License Application (BLA) or BLA efficacy supplement as
part of inter-office, interdisciplinary review teams, and provides
recommendations for post-market safety monitoring, post-marketing requirement
(PMR) studies and Risk Evaluation and Mitigation Strategies (REMS) under
FDAAA. Reviews labelling supplements for safety-related label changes. Reviews
the design, evaluates the implementation and clinical safety data from Phase
IV post-marketing surveillance studies conducted by regulated industry.
D. Performs reviews of other safety data analyses submitted by regulated
industry.
4 Pharmacovigilance Branch 3 (DCBDB3)
A. Monitors the post-market safety of CBER-regulated biological products to
inform regulatory decisions.
B. Develops, maintains, monitors, and analyzes national safety surveillance
databases of adverse events to biological products, including vaccines,
cellular and gene therapies, blood and blood derived products, and tissue
allografts. Coordinates the Center adverse event reporting systems.
C. Performs pharmacovigilance review to assess the adequacy of the
pharmacovigilance plan based on the safety profile data submitted in an
original Biological License Application (BLA) or BLA efficacy supplement as
part of inter-office, interdisciplinary review teams, and provides
recommendations for post-market safety monitoring, post-marketing requirement
(PMR) studies and Risk Evaluation and Mitigation Strategies (REMS) under
FDAAA. Reviews labeling supplements for safety-related label changes. Reviews
the design, evaluates the implementation and clinical safety data from Phase
IV post-marketing surveillance studies conducted by regulated industry.
D. Performs reviews of other safety data analyses submitted by regulated
industry.
5 Authority and Effective Date.
The functional statements for the Office of Biostatistics and Pharmacovigilance, Division of Pharmacovigilance were approved by the Commissioner of Food and Drugs and effective on September 30, 2022.
Staff Manual 1213.3 Organizations and Functions Effective Date: September 30, 2022
The following is the Department of Health and Human Services, Food and Drug
Administration, Center for Biologics Evaluation and Research, Office of
Biostatistics and Pharmacovigilance, Division of Pharmacovigilance
organization structure depicting all the organizational structures reporting
to the Director: Division of Pharmacovigilance (DCBDB)
These organizations report to the Division of Pharmacovigilance:
Pharmacovigilance Branch 1 (DCBDB1)
Pharmacovigilance Branch 2 (DCBDB2)
Pharmacovigilance Branch 3 (DCBDB3)