CDER reorganization continues with new offices and divisions

Regulatory NewsRegulatory News | 08 January 2021 |  By 

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Friday detailed plans to reorganize five of its offices this year.
In an email to staff, Acting CDER Director Patricia Cavazzoni said the approved structural changes in the Office of Generic Drugs (OGD), Office of Strategic Programs (OSP), Office of Surveillance and Epidemiology (OSE), Office of Management and Office of Compliance “will enable us to respond to new priorities more effectively and efficiently.”
The announcement follows a multi-year effort by CDER to modernize its new drug program that led to the reorganization of the Office of New Drugs that wrapped up last year. (CDER director details plans to modernize OND, Regulatory Focus 4 June 2018; CDER kicks off final phase of OND reorganization, Regulatory Focus 18 March 2020).
The latest reorganization will see the establishment of a new Office of Safety and Clinical Evaluation within OGD, which has seen a high volume of abbreviated new drug applications (ANDAs) for new and complex products in recent years.
The new office will pull the Division of Clinical Review and the Division of Pharmacology Toxicology Review from OGD’s Office of Bioequivalence and the division of Clinical Safety and Surveillance from OGD’s Immediate Office.
FDA also announced that it will stand up new divisions in other OGD offices, including the Division of Bioequivalence Process Management, the Division of Therapeutic Performance II and the Division of Orange Book Publication and Regulatory Assessment and that it will shift the Division of Quality Management Systems to OGD’s Immediate Office as the Quality Management Systems Staff.
“Through the reorganization, OGD intends to continue its focus on ensuring a more efficient review process and create a stronger alignment of administrative, regulatory project management, program operations, policy, and drug development tool services. Modernizing OGD operations will help staff perform FDA’s mission effectively in an environment of rapidly evolving science, changing stakeholder expectations, and new statutory authorities and responsibilities,” OGD said.
Within OSP, the reorganization will formalize six existing teams within the Immediate Office and the Office of Program and Strategic Analysis (OPSA) that work on strategic and operational planning and provide oversight to enterprise data informatics and data standards initiatives.
The reorganization will see the creation of two new divisions within OSE, the Division of Medication Error and Prevention and Analysis I (DMEPA I) and the Division of Medication Error and Prevention II (DMEPA II), which will be split from the current Office of Medication Error Prevention and Risk Management, as well as the creation of the Division of Mitigation Assessment and Medication Error Surveillance.
“OSE’s changes will strengthen the post-0market medication error surveillance and risk mitigation assessment functions, including those for opioids as we continue our work to address the opioid crisis. The restructuring will also expand staff’s scientific expertise to provide for better regulatory decisions and support the development of more industry guidances,” Cavazzoni said.
The Office of Management will have its Strategic Programs & Initiatives Staff realigned to other positions within the office and the Office of Compliance will stand up a new Office of Compounding Quality and Compliance to centralize various components of CDER’s compounding program.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy