CBER director Peter Marks and three medical center researchers editorialize on the value of registries to promote convalescent plasma therapy in the n...
Organon says it agrees with an FDA policy change to have a biosimilar statement accompany both biosimilars and interchangeables.
Reps. Marie Gluesenkamp Perez (D-WA), Sean Casten (D-IL), and Gerry Connolly (D-VA) introduce a bill to ban brand companies from entering into pay-for...
Federal Register notice: FDA makes available a guidance entitled Real-Time Oncology Review (RTOR).
FDA releases the form FDA-483 with 14 observations from an inspection at the Kilitch Healthcare India sterile drug manufacturing facility in Maharasht...
Federal Register notice: FDA proposes to withdraw approval of Phibro Animal Healths NADAs for carbadox in medicated swine feed.
The International Society for Cell & Gene Therapy suggests ways to improve an FDA draft guidance on manufacturing changes and comparability for human ...
In a major move against questionable drug patents, the FTC challenges the legitimacy of more than 100 patents listed in FDAs Orange Book.
