Regulatory Status Conditions

A collaborative U.S. model

Authorized by the 21st Century Cures Act, the U.S. Food and Drug Administration’s Oncology Center of Excellence (OCE) was created in 2017 to “facilitate the development and clinical review of oncology products by uniting scientific experts across the FDA’s product centers to conduct expedited review of drugs, biologics, and devices.”
OCE’s stated directives are to facilitate development and regulation of oncology products with a patient-centered approach, through collaborative decision-making. To this end, OCE employs scientists and reviewers with expertise in drugs, biologics (drugs derived from living organisms), diagnostics and devices.

Several other FDA entities work in collaboration with OCE’s Oncology Regulatory Affairs section, including:

  • Office of Oncologic Diseases (OOD) – Oversees development, approval and regulation of drug and biologic treatments for cancer and hematological malignancies
  • Center for Drug Evaluation and Research (CDER) – Regulates over-the-counter and prescription drugs and biological therapeutics
  • Center for Biologics Evaluation and Research (CBER) – Regulates biological products for human use; ensures safety and efficacy and provides the public with information on appropriate use of biological products

Center for Devices and Radiological Health (CDRH) – Provides patients and healthcare facilities with reliable access to safe, effective, and high-quality medical devices and safe radiation-emitting products; provide industry with transparent and efficient regulatory pathways

Oncology Regulatory Affairs seeks to coordinate efforts among these centers to scrutinize medical oncology products under OCE review, as well as to:

  • Develop and implement procedures for improving the review process across centers
  • Facilitate OCE policy development
  • Provide a forum for the exchange of ideas and streamlining of regulatory review processes


"Center for Drug Evaluation and Research | CDER | FDA." U.S. Food and Drug Administration, FDA,
"Office of Oncologic Diseases (OOD) | FDA." U.S. Food and Drug Administration, FDA,
"Oncology Regulatory Affairs | FDA." U.S. Food and Drug Administration, FDA,
"Regulation of Biologic Oncology Products in the FDA׳s Center for Biologics Evaluation and Research - PubMed." PubMed,

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