Regulatory

FDA’s CDER unveils details of reorganization

The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) on Thursday announced the details of a major reorganization, affecting nearly one-third of CDER.

The proposed reorganization will impact the Office of New Drugs, Office of Compliance, Office of Executive Programs, and Office of Communications and has been submitted to HHS, though still must be approved by HHS and submitted to Congress for concurrence. The changes will be in effect once approval is received and the 30-day congressional notification has lapsed, FDA said.

FDA also noted that the changes are not part of a separate effort related to the New Drugs Regulatory program Modernization, which is a longer-term effort including a broader reorganization of OND.

Office of New Drugs (OND)

The changes announced Thursday include the creation of a new Office of Therapeutic Biologics and Biosimilars (OTBB) within OND, which will house policy staff and scientific review staff. The restructuring will also realign staff from the OND Immediate Office to the new OTBB and will help in implementing the reauthorized Biosimilar User Fee Act (BsUFA II).

“OTBB will give biosimilar and interchangeable product review a stronger infrastructure with resources to streamline and advance policy development,” FDA said. “The increasing complexities and visibility of this program require a dedicated office to efficiently and effectively achieve cross-organizational coordination and collaboration.”

Office of Compliance (OC)

The Office of Unapproved Drugs and Labeling Compliance will house the Division of Compounded Drugs, formerly known as the Division of Prescription Drugs.

“This change will better reflect our critical work relating to compounding policy and oversight, as the division will absorb the functions of the former Compounding and Pharmacy Practice Branch. It will establish three new branches relating to compounding policy, regulatory actions, and operations – and realign the Prescription Drugs Branch with a new Division of Unapproved New Drugs, formerly the Division of Non-Prescription Drugs & Health Fraud. New branch names will better reflect the division’s mission and goals,” FDA said.

In addition, the Office of Manufacturing Quality (OMQ) will establish a third drug quality division with two branches for global compliance. And the Office of Drug Security, Integrity, and Response will rename its Division of Imports, Exports, and Recalls to the Division of Global Drug Distribution and Policy to reflect the agency’s responsibility in ensuring the safety and quality of drug products flowing into and out of the US.

Office of Executive Programs (OEP)

OEP is restructuring to address the growing volume and complexity of managing CDER’s executive programs.
“The OEP changes will establish four staff groups within OEP’s Immediate Office focusing on special projects, executive secretariat matters, legislative activities, and program management and analysis – absorbing the functions of the former Division of Executive Operations. The restructuring will also establish two branches within the Division of Advisory Committee and Consultant Management to manage and oversee advisory committee and conflict of interest matters,” FDA said.

Office of Communications (OCOMM)

OCOMM’s changes include establishing three branches within the existing Division of Drug Information. OCOMM will also rename two divisions to better reflect their expanded mission. The Division of Health Communications will become the Division of Public Education and Outreach, and the Division of Online Communications will become the Division of Digital and Online Communication.


First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email news@raps.org for more information. 


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