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  1. Guidance, Compliance & Regulatory Information (Biologics)

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.

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