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  4. Division of Case Management (DCM)
  1. Guidance, Compliance & Regulatory Information (Biologics)

Division of Case Management (DCM)

The Division of Case Management (DCM) within OCBQ has many responsibilities, including the following:

Inspection, Surveillance, and Compliance Activities

  • Reviews and evaluates administrative action recommendations including suspension, revocation, and denial of license. Reviews recommended civil and criminal actions, including seizure, injunction, and prosecution. Prepares documents required for such enforcement actions and manages cases after actions are taken.
  • Develops enforcement standards for direct reference authority to the Office of Regulatory Affairs (ORA) for issuance of warning letters, and reviews and evaluates recommendations for the issuance of warning letters for which direct reference authority had not been granted.
  • Directs the recall program for CBER-regulated products, including voluntary and FDA requested recalls, as well as orders for recall of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).
  • Directs and coordinates CBER's import and export programs, including review of requests for export of unapproved biological products.
  • Reviews, evaluates, and takes appropriate compliance actions on advertising and promotional labeling materials for CBER-regulated products to ensure that the information about the risks and benefits of regulated products are communicated in a truthful, accurate, science-based, non-misleading and balanced manner, and is in compliance with pertinent laws and regulations.

Pre- and Post-Market Approval Activities

  • Provides assessment of the compliance status of regulated establishments within CBER's purview (compliance status checks).
  • Evaluates proposed proprietary names to avoid potential medication errors related to look-alike and sound-alike proprietary names and mitigating other factors that contribute to medication errors, such as unclear label abbreviations, acronyms, dose designations, and error prone label and packaging design.
  • Provides consultative reviews of proposed product labeling.

Additional Information about DCM

Additional information about DCM's responsibilities is available in FDA’s Staff Manual Guide.

Related Information

Additional Compliance, Inspection, and Enforcement Resources

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