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FDA publishes a draft guidance in question-and-answer format on using whole slide images in nonclinical toxicology studies.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.
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Three drug companies comment on an FDA draft guidance on the labeling content and format of immunogenicity information in human prescription therapeut...