FDA warns Bethesda, MD-based RightEye that it is promoting off-label use of its adulterated and misbranded RightEye Vision System.
FDA warns Chandler, AZ-based Adept Life Science about CGMP and misbranding violations in its production of dietary supplements.
FDA issues the FY 2022 GDUFA Science and Research Report with information on projects in 13 scientific areas.
Two FDAers introduce a journal issue exploring ways in which clinical pharmacology innovations can expand the development and approval of biosimilars.
FDA publishes a draft guidance with considerations for designing and conducting externally controlled trials for drug and biological products.
Two Epstein Becker attorneys say an FDA statement challenging the 11th Circuit Court of Appeals application of its position on orphan drug exclusivity...
FDA publishes its 2023 guidance agenda listing 11 guidances it is considering developing this year.
The Biden Administration announces that it will end the current Covid-19 public health emergency declaration and national emergency declaration, which...
