BioPharma Dive

Richard Pazdur, longtime FDA oncology leader, to head agency’s main drug office

The appointment of Pazdur as CDER head comes shortly after the surprise ousting of George Tidmarsh and should quiet many of ...
JD Supra

FDA’s Center for Drug Evaluation and Research (CDER) Issues FY2023 Annual Report

In January 2024, the Office of Compliance at the FDA’s Center for Drug Evaluation Research (CDER) released its Annual Report for FY2023. The Annual Report contains several useful pieces of information ...
FierceBiotech

FDA wants to boost trial innovation with new center at CDER

The FDA's Center for Drug Evaluation and Research, or CDER, has established a new center for communication between CDER staff and stakeholders involved in clinical trials, according to an April 15 ...
JD Supra

FDA Reduction-In-Force expected to impact drug & biologic review and regulation, other operations

Although HHS says it did not target FDA product reviewers or inspectors, FDA employees who assist with reviews in various capacities were let go, including project managers and staff in administration ...
Nasdaq

Vanda Seeks FDA Commissioner Review of Outgoing CDER Director's Decision to Uphold Approval of Two Generic Versions of Hetlioz®

WASHINGTON, Aug. 21, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has asked Martin Makary, the Commissioner of the U.S. Food and Drug Administration ...