Bayer asks FDA to confirm that it will apply a 30-month stay to an Apotex ANDA for a generic form of Bayers Astelin nasal spray.
Minerva Neurosciences says FDA continues to have questions and concerns about its proposed NDA for roluperidone to treat negative symptoms of schizoph...
Federal Register notice: FDA seeks comments on an information collection revision entitled Medical Devices; Humanitarian Use Devices 21 CFR Part 814....
FDA publishes a draft guidance in question-and-answer format on using whole slide images in nonclinical toxicology studies.
FDA commissioner Robert Califf lays out a six-step plan to better leverage health technology, data, and capabilities to improve healthcare outcomes an...
FDA associate commissioner for regulatory affairs Judith McMeekin shares ORAs experience during the pandemic about relying on inspection reports under...
CBER director Peter Marks outlines ways in which FDA and other stakeholders could expedite the development of gene therapies.
FDA publishes a guidance to help sponsors develop drugs and biologics to treat chronic hepatitis B virus.