Regulatory Roundup: FDA Makes Organizational Changes Within CDER - Pharmaceutical Technology

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Regulatory Roundup: FDA Makes Organizational Changes Within CDER

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA is making organizational changes within the Center for Drug Evaluation and Research’s (CDER) Office of Oncology Drug Products, which is the office that reviews drug and biologic applications for cancer therapies. The office will now be called the Office of Hematology and Oncology Products (OHOP). Richard Pazdur, MD, will continue to serve as the office director, according to an agency press release. The new structure contains four divisions: Division of Hematology Products (DHP), Division of Oncology Products 1 (DOP1), Division of Oncology Products 2 (DOP2), and Division of Hematology Oncology Toxicology (DHOT). “Two unique features of the reorganization include the creation of DOP1 and DOP2, the agency’s primary review divisions for cancer solid tumor therapies, and the creation of DHOT, which will review nonclinical information,” states the release. The division directors for each division are listed on the agency website. The agency’s Office of Compliance was also restructured earlier this year.

PDA has updated its membership structure to include an expanded Emerging Economy membership, a new option for Retired Membership, and additional assistance for members who are currently seeking employment in the Pharmaceutical industry, according to a press release. The association is holding its annual regulatory meeting with FDA next week Sept. 19-21, in Washington, DC. Listen to PharmTech’s preview coverage.


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