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The International Society for Cell & Gene Therapy suggests ways to improve an FDA draft guidance on manufacturing changes and comparability for human ...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.
Two Hyman, Phelps & McNamara staff say FDA missed an opportunity to conduct many remote interactive evaluations of drug manufacturing sites.
