Vaccines, Blood & Biologics
Resources for You
- Administrative Guidances (Searchable by Publication Year)
- Labeling and Promotion Guidances (Searchable by Publication Year)
- Adverse Events and Product Deviation Guidances (Searchable by Publication Year)
- CMC and GMP Guidances (Searchable by Publication Year)
FDA Guidance Documents: General and Cross-Cutting Topics Guidance for Industry: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide
- Overview of Food and Drug Administration Safety and Innovation Act (FDASIA)
- Return to Office of Compliance and Biologics Quality (OCBQ) Page
Immediate Office of the Director (IOD) of OCBQ
The Immediate Office of the Director (IOD) of OCBQ has many responsibilities, including the following:
The Immediate Office of the Director (IOD) within OCBQ provides leadership and administrative oversight for the Office's multifaceted activities and organizational responsibilities, including in such areas as:
- policy making,
- program direction and coordination,
- liaison responsibilities,
- and providing subject matter expert advice to the Center Director and other Agency officials in support of CBER's inspection, compliance and surveillance related activities, and its science-based regulatory work.
Compliance-Related Policy Activities
The IOD staff within OCBQ participate in and contribute to a wide variety of compliance-related policy and science-based regulatory activities, including the following:
- Contributes to policy development within CBER, as well across other FDA Centers, including the development of guidance documents, rulemaking, SOPPs, Compliance Policy Guides, and FDA Staff Manual Guides.
- Conducts policy analyses and reviews, including the review and clearance of OCBQ-authored policy documents, white papers, charters, and strategic plans.
- Participates in Intra-Agency, Inter-Agency, and Intra-Center working groups.
- Laws FDA Enforces: Historical Summary and Other Related Links
- FDASIA: PDF file of the Act
PDUFA V: Fiscal Years 2013 - 2017
- Information on Biosimilars
- Code of Federal Regulations (CFRs) (Searchable)
- Additional FDA References for Enforcement and Compliance Actions
- GPO: Federal Register Notices, 1994-present (Searchable)
- HEINONLINE: Federal Register Notices, particularly useful for those issued prior to 1994 (Searchable)
- FDA's Regulatory Procedures Manual (Searchable)
Manual of Compliance Policy Guides Compliance Program Guidance Manual (CPGM) Revisions to Compliance Manuals