Federal Register notice: FDA announces three public meetings entitled Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting Sy...
Federal Register proposed rule: FDA proposes to amend its regulations to implement a provision of the 21st Century Cures Act that would allow an excep...
FDA says Oscor has expanded the time period covered in its recall of TB pacing leads to ensure proper disposition of expired units.
FDA grants Seattle Genetics a breakthrough therapy designation for Adcetris (brentuximab vedotin) for previously untreated systemic anaplastic large c...
FDA says a GE Healthcare recall of Millennium nuclear medicine imaging systems is Class 1.
Novartis says FDA and HHS could do more to counter false information about and promote increased use of biosimilars and interchangeable biologic produ...
CDER Office of Communications associate director Paula Rausch describes how FDA monitors social media and online conversations as a first step in deve...
Two FDA advisory committees vote in a joint meeting to recommend approval of Mallinckrodt subsidiary SpecGxs investigative abuse-deterrent formulation...