September 26, 2019
“Last summer we announced our plan to modernize the FDA Center for Drug Evaluation and Research’s New Drugs Regulatory Program. We set out with a vision of streamlining resources so that our physicians and staff can dedicate more time to drug development activities, particularly drugs under the FDA’s review for unmet medical needs. We also have the goal of elevating the role of our scientists and medical officers to take on even more thought leadership in their fields, allowing us to be more effective and efficient. I am proud to say that the reorganization aspect of the New Drugs Regulatory Program modernization effort has cleared Congress, and we are now entering the next phase of our plan,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Modernizing our operations helps us perform our mission effectively in an environment of rapidly evolving science, changing stakeholder expectations, and new statutory authorities and responsibilities. The new structure will strengthen operations in a number of CDER offices and will allow the FDA to better meet the evolving needs of new drug review. Our goal with this modernization effort, including this reorganization, is to bolster the Center’s mission and ensure that safe, effective, high-quality drugs are available for the American public. Through the reorganization of certain offices within the New Drugs Regulatory Program, we hope to promote a more efficient review process and create a stronger alignment of administrative, regulatory project management, program operations, policy and drug development tool services.”
Today, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) announced that the reorganization of certain offices within the New Drugs Regulatory Program (NDRP) has been approved. The new structure will strengthen CDER’s Office of New Drugs (OND) operations and will allow the FDA to better meet the evolving needs of new drug review by increasing the number of reviewing divisions, allowing each to specialize in certain types of drugs, while also increasing the effectiveness and efficiency of review. The Office of Translational Sciences (OTS) and the Office of Pharmaceutical Quality (OPQ), which work closely with OND, are also undergoing a restructuring of clinical offices and divisions as part of this reorganization.
This reorganization of OND – and changes in OTS and OPQ – is part of CDER’s modernization effort, first announced in June 2018, which is an ongoing, multi-phase regulatory improvement initiative comprised of structural changes, process and documentation improvements, and enhancements to administrative and regulatory operations.
Changes that will now begin include:
- Grouping OND offices and divisions by therapeutic area to distribute workload and align to changes in the pharmaceutical landscape;
- Increasing the number of clinical offices that oversee review divisions from six to eight;
- Increasing the number of clinical divisions from 19 to 27, plus six divisions of pharmacology/toxicology, creating divisions with clearer and more focused areas of expertise; and
- Establishing the new Offices of Program, Administrative, and Regulatory Operations; an Office of New Drug Policy; and an Office of Drug Evaluation Sciences.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.