OGD Publishes Full Leadership And Divisional Structures For ANDAs

For regulatory affairs leads managing Abbreviated New Drug Application (ANDA) portfolios, the FDA's Office of Generic Drugs has published an updated directory of its leadership and sub-office structure, clarifying which divisions hold authority over bioequivalence review, patent and exclusivity determinations, and Orange Book maintenance.

The Immediate Office, now under Director Iilun C. Murphy, M.D., provides strategic oversight across five sub-offices: the Office of Bioequivalence (OB), Office of Generic Drug Regulatory Affairs (OGDRA), Office of Regulatory Operations, Office of Research and Standards, and Office of Safety and Clinical Evaluation. A dedicated Global Generic Drug Affairs Team sits within the Immediate Office, coordinating international engagement on generic medicine science and regulation.

Within OB, three Divisions of Bioequivalence assess pharmacokinetic, pharmacodynamic, and in vitro data to confirm therapeutic equivalence, including excipient safety, formulation proportionality, and Q1/Q2 sameness. A separate Division of Bioequivalence Process Management handles workload coordination and meeting management across the full ANDA lifecycle, a structural detail relevant to sponsors tracking review timelines.

OGDRA carries the regulatory and legal weight of the generic drug program. Its Division of Legal and Regulatory Support advises on Hatch-Waxman matters, patent and exclusivity decisions, and expedited review pathways for first generics and drug shortage submissions. The Division of Orange Book Publication and Regulatory Assessment maintains the authoritative reference on therapeutic equivalence ratings, market availability, and substitutability data. The Division of Regulatory Strategy Development leads implementation of regulations and guidances under the Generic Drug User Fee Amendments (GDUFA), ensuring policy consistency across CDER.

For ANDA filers, knowing which division holds jurisdiction over a specific review function reduces misdirected inquiries and supports more precise engagement during the submission and deficiency-response cycle.

The directory's publication against the current GDUFA performance period makes it a practical reference for regulatory operations teams benchmarking submission timelines against OGD's stated divisional responsibilities.

Source: FDA Center for Drug Evaluation and Research via FDA.gov What's New: Drugs RSS Feed, October 1, 2026.