Federal Register notice: FDA makes available a final guidance on clinical development recommendations for hepatitis B virus infection drug products.
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...
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.
FDA publishes for comment a draft of revisions to the International Council for Harmonization M7 guideline on calculating compound-specific acceptable...
Three drug companies comment on an FDA draft guidance on the labeling content and format of immunogenicity information in human prescription therapeut...
Federal Register notice: FDA announces a 4/19 virtual public meeting entitled Medical Device User Fee Amendments to discuss proposed recommendations f...