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...
FDA grants a de novo marketing authorization for over-the-counter Healgen Rapid Check Covid-19/Flu A&B Antigen Test.
