Responding to changes required by the 21st Century Cures Act, the FDA has unveiled its principles for post market surveillance of drug safety in the final version of a 2019…

The FDA has until March 5 to provide an answer for Vanda Pharmaceuticals’ five-year quest to understand why the FDA denied the company’s supplemental New Drug Application (sNDA) for Hetlioz…

The CDRH Office of Strategic Partnerships and Technology Innovation (OST) has been elevated to a super office, effective immediately, a designation that the FDA says will allow OST to adapt…

The FDA has expanded its use of in-person face-to-face (FTF) meetings for additional application types, and have expanded its definition of FTF meetings to include hybrid meetings which combine in-person…

As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws…

In this edition of Quick Notes, we hop across the pond to check out the EMA’s new regulatory fees structure, its updated submissions communication portal, and the sixth update of…

Strong nonclinical testing should underpin development programs for both gene editing (GE) products and chimeric antigen receptor (CAR-T) cellular products, according to two new final guidances issued by the FDA.…

During its second town hall on reducing the use of ethylene oxide (EtO) to sterilize medical devices, FDA officials announced the creation of a dedicated EtO “tiger team” with expertise…

In a move that caught many industry experts unaware, the U.S. government last week announced the sale of the Federal Helium Reserve to a private company, despite warnings about the…

Manufacturers with tentatively approved ANDAs can look to a recently issued FDA final guidance for information on how to prepare and submit amendments as well as make requests to get…