An FDA Science Advisory Board subcommittee calls on the agency to create a centralized office to coordinate work on New Alternative Methods.
FDA warns the Louisiana State University institutional review board that it failed to follow legislation and regulations to protect human subjects.
FDA releases the form FDA-483 with 10 observations from an inspection at the Apitoria Pharma active pharmaceutical ingredient manufacturing facility i...
FDA releases the form FDA-483 issued following an inspection at the Biocon sterile drug product manufacturing facility in Johor, Malaysia.
The House Energy and Commerce Committee asks FDA for a staff briefing about the presence of counterfeit copies of Novo Nordisks Ozempic (semaglutide) ...
Sentec/Percussionaire recalls (Class 1 device correction) its Phasitron 5 In-Line Valve to update use instructions due to an increase in reports of pa...
University researchers worldwide urge FDA to reevaluate its use of a Boxed Warning in labeling for youth antidepressants after studies show it is asso...
FDA reviewers appear unconvinced that a Stealth BioTherapeutics NDA for elamipretide, a mitochondria-targeted therapy for treating Barth syndrome, con...
