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FDA publishes a draft guidance with considerations for designing and conducting externally controlled trials for drug and biological products.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...
After more than 22 years at FDA, CBER Office of Tissues and Advanced Therapies director Wilson Bryan announces he is retiring in March.
FDA commissioner Robert Califf announces a new transformative vision for the agencys human foods program and the Office of Regulatory Affairs that add...
Federal Register notice: FDA announces the issuance of two Emergency Use Authorizations for diagnostic devices intended for use during the ongoing Mon...
