A plan to slash drug review times at the Food and Drug Administration is sparking deep concerns among agency staffers and ...

Nearly 39,000 gallons of bottled water have been voluntarily recalled by Meijer, according to a U.S. Food and Drug ...

Target action dates for drugs sponsored by Sanofi, Boehringer Ingelheim and Disc Medicine have also been pushed back despite ...

The FDA recently announced that it found insufficient data to determine the safety of per- and polyfluoroalkyl substances, ...

A key element of the law is the establishment of a system to trace food, which is key to reducing the severity of foodborne ...

FDA officials told GAO that competing priorities and an agency reorganization in late 2024 have slowed progress, estimating ...

Americans cannot rely on the Food & Drug Administration (FDA) to guarantee that medical devices are safe, and a recent Government Accountability ...

The nation's top food and product regulator said there are "significant" gaps in scientists' understanding of how PFAS in ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

The repeat problems at Houston-based Empower Pharmacy include inadequate quality testing and a failure to clean equipment.

Low staffing at the FDA has prevented the agency from adequately overseeing the more than 190,000 devices under its purview, according to a Dec. 12 report from ProPublica and the Pittsburgh ...