Add Yahoo as a preferred source to see more of our stories on Google. The US Food and Drug Administration (FDA) has a new chief drug regulator, with industry veteran Dr Richard Pazdur taking the helm ...

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 ...

One surprising consequence of the coronavirus pandemic and its work-from-home zeitgeist? Biopharma companies have been compelled to rethink and perhaps even improve how they operate their businesses.

As the division of FDA responsible for regulating drugs and certain biologics, CDER’s authority includes overseeing the development and testing of such products. As technology advancements and ...

In a surprise move, the FDA has named the longtime leader of its oncology department, Richard Pazdur, M.D., as the new director of the Center for Drug Evaluation and Research, which oversees most ...

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 ...