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 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:

• Contributes to 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.
• Participates in Intra-Agency, Inter-Agency, and Intra-Center working groups.

Related Information

• 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 Programs
• Revisions to Compliance Manuals

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
• Overview of Food and Drug Administration Safety and Innovation Act (FDASIA)
• Return to Office of Compliance and Biologics Quality (OCBQ) Page