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 andcoordination,
- liaison responsibilities,
- and providing subject matter expert advice to the Center Director and other Agency officialsin 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 regulatoryactivities, including the following:
- Contributesto policy development withinCBER, 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.
- Participatesin 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