Federal Register notice: FDA makes available a final guidance entitled Premenopausal Women with Breast Cancer: Developing Drugs for Treatment.
Federal Register notice: FDA announces a 9/21 public workshop entitled Considerations for Progressive Multifocal Leukoencephalopathy Clinical Trial De...
Bausch Health petitions FDA to apply its specified bioequivalence and pharmaceutical equivalence criteria to the approval of any ANDA citing its Duobr...
FDA issues a draft guidance to clarify whether activities performed on medical devices are likely remanufacturing.
FDA says Philips has notified customers about possible risks associated with the sound abatement foam used in three of its products.
FDA accepts AcelRxs plans to update Dsuvia promotional materials that were the subject of an agency Warning Letter.
FDA says a Medtronic recall of 55,000 angiographic guidewire components is Class 1.
FDA issues an immediately-in-effect guidance to help sponsors develop drugs and biological products to treat or prevent acute Covid-19.