Researchers say the use of pediatric extrapolation in a six-year period increased the rate of new and expanded pediatric indications.
The outgoing director of the CBER Office of Tissues and Advanced Therapies, Wilson Bryan, expresses concern about the length of confirmatory trials ne...
FDA clears a 510(k) submitted by Belgium-based Sunrise for its second generation at-home sleep apnea test that uses artificial intelligence to aid in ...
Two Morgan Lewis attorneys explore decisions facing FDA in light of an 11th Circuit Court of Appeals ruling on orphan drug exclusivity that FDA disagr...
AdvaMed suggests changes to an FDA draft guidance on delaying, denying, limiting, or refusing a drug or device inspection.
A joint FDA advisory committee meeting votes to recommend the nonprescription use of Emergent BioSolutions Narcan (naloxone HCl) nasal spray for treat...
Federal Register notice: FDA sends to OMB an information collection revision entitled Medical Device Labeling Requirements; Unique Device Identificati...
Federal Register notice: FDA makes available a draft guidance entitled Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neon...
