Vaccines, Blood & Biologics
Resources for You
SOPP 8401: Administrative Processing of Biologics License Application (BLA) SOPP 8401.4: Review Responsibilities for the CMC Section of Biologic License Applications and Supplements SOPP 8410: Determining When Pre-License / Pre-Approval Inspections are Necessary SOPP 8101.1: Scheduling and Conduct of Regulatory Review Meetings with Sponsors and Applicants Formal Meetings Between the FDA and Sponsors or Applicants_PRA(PDF - 95KB) Information on Submitting an Investigational New Drug Application
- CMC and GMP Guidances (Listed by Publication Year)
- Return to Office of Compliance and Biologics Quality (OCBQ) Page
Division of Manufacturing and Product Quality (DMPQ)
The Division of Manufacturing and Product Quality (DMPQ) within OCBQ has many responsibilities, including the following:
- Manages the overall program responsibilities for the Division, primarily lot release, review of application-based submissions, and inspections.
- Reviews, evaluates, and takes appropriate action on Investigational New Drug applications (INDs), marketing applications, supplements, and amendments submitted to CBER, as part of the managed review process. Performs Chemistry, Manufacturing, and Controls (CMC) and Current Good Manufacturing Practice (CGMP) reviews for specific CBER-regulated products.
- Performs quality assurance review of completed submissions for consistency in technical content as well as administrative process requirements.
Product Release Branch
- Develops and administers the biological products lot release program, in coordination with other CBER components.
- Reviews manufacturers' submissions for licensed biological product lots.
- Receives, maintains, and distributes samples of biological products submitted for testing.
- Provides the final quality review for lot release submissions and prepares release correspondence for company notifications.
The Product Release Branch recommends the following resources for manufacturers.
Manufacturing and Review Branches 1 and 2
- Reviews, evaluates, and takes appropriate action on INDs, marketing applications, supplements, and amendments submitted to CBER) as part of the managed review process. Performs CMC and CGMP reviews.
- Meets with manufacturers to review facility design/CGMP/new products and technologies.
- Leads prelicense and preapproval inspections supporting Biologics License Application submissions and supplements, as part of the CBER managed review process. Prepares inspection reports as part of an inspection team and evaluates firms’ corrective actions.
The Manufacturing and Review Branches recommend the following resources for manufacturers.
Applications Review Branch
- Prepares review packages and correspondence for final action on supplements. Schedules and coordinates meetings with industry as well as finalizes meeting minutes for distribution.
- Performs all data entry for assignment and tracking of submissions and also generates work load reports in order to maintain operations within the designated PDUFA and MDUFMA time frames.
- Issues and reissues U.S. and biologics licenses.
Additional Information about DMPQ
Additional information about DMPQ's responsibilities is available in FDA’s Staff Manual Guide.
- CBER Approved Products
- FDA Inspection Reference, Guides, and Field Activities
- FDA Compliance Manuals
- Additional FDA References for Enforcement and Compliance Actions
- CFR- Code of Federal Regulations Title 21
Investigational New Drug (IND) or Device Exemption (IDE) Process (CBER) Biologics License Applications (BLA) Process (CBER) New Drug Application (NDA) Process (CBER) Premarket Approval (PMA) Process (CBER) 510(k) Process (CBER)