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FDA warns the Louisiana State University institutional review board that it failed to follow legislation and regulations to protec...[ Price : $8.95]
FDA releases the form FDA-483 with 10 observations from an inspection at the Apitoria Pharma active pharmaceutical ingredient manu...[ Price : $8.95]
FDA releases the form FDA-483 issued following an inspection at the Biocon sterile drug product manufacturing facility in Johor, M...[ Price : $8.95]
The House Energy and Commerce Committee asks FDA for a staff briefing about the presence of counterfeit copies of Novo Nordisks Oz...[ Price : $8.95]
Sentec/Percussionaire recalls (Class 1 device correction) its Phasitron 5 In-Line Valve to update use instructions due to an incre...[ Price : $8.95]
University researchers worldwide urge FDA to reevaluate its use of a Boxed Warning in labeling for youth antidepressants after stu...[ Price : $8.95]
FDA reviewers appear unconvinced that a Stealth BioTherapeutics NDA for elamipretide, a mitochondria-targeted therapy for treating...[ Price : $8.95]
FDA grants a de novo marketing authorization for over-the-counter Healgen Rapid Check Covid-19/Flu A&B Antigen Test.