Companies who run their early-stage clinical development outside the U.S. would “experience higher fees” according to an FDA ...

As the FDA's Commissioner's National Priority Voucher (CNPV) program has picked up steam, with 15 companies now having ...

FDA moves reshaping drug policy include fast-track programs, updated biosimilar guidance, and new rare disease approval pathways.

The FDA says it is hiring more than 1,000 new employees and rolling out a pilot communication program in efforts to speed up the review of new drugs. | The FDA is hiring more than 1,000 new employees ...

FDA launches digital health pilot to ease regulations and boost innovation in managing chronic diseases like heart failure and depression.

On , The US Food and Drug Administration issued draft guidance identifying specific types of monoclonal antibody products for which the agency believes six-month toxicity testing in non-human primates ...

Richard Pazdur, the new director of the Center for Drug Evaluation and Research, raised concerns amid the rollout of several ...

The agency says agentic AI deployment will enable its staff to further advance the use of AI to assist with more complex ...

The name “340B” comes from the section of the U.S. Public Health Service Act of 1992 that requires pharmaceutical ...

Pazdur, who has worked at the FDA for 26 years, told senior leaders on Tuesday that he plans to step down, just weeks after ...