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Objectionable Conditions at LSU Institutional Review Board

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FDA warns the Louisiana State University institutional review board that it failed to follow legislation and regulations to protec...

FDA Releases Apitoria Pharma FDA-483

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FDA releases the form FDA-483 with 10 observations from an inspection at the Apitoria Pharma active pharmaceutical ingredient manu...

8 Observations in Biocon FDA-483

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FDA releases the form FDA-483 issued following an inspection at the Biocon sterile drug product manufacturing facility in Johor, M...

House Wants FDA Briefing on Fake Ozempic

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The House Energy and Commerce Committee asks FDA for a staff briefing about the presence of counterfeit copies of Novo Nordisks Oz...

Sentec/Percussionaire Recalls Ventilator Valve

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Sentec/Percussionaire recalls (Class 1 device correction) its Phasitron 5 In-Line Valve to update use instructions due to an incre...

More Suicide Deaths Linked to FDA Antidepressant Warnings

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University researchers worldwide urge FDA to reevaluate its use of a Boxed Warning in labeling for youth antidepressants after stu...

FDA Questions Data in Stealth NDA for Barth Syndrome

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FDA reviewers appear unconvinced that a Stealth BioTherapeutics NDA for elamipretide, a mitochondria-targeted therapy for treating...

Covid/Flu Rapid Test Authorized for OTC Use

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

Workshop Advances Brain/Computer Interface Assessment

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FDA releases the transcript from a two-day workshop held in conjunction with NIH on developing clinical outcome assessments to dem...

Two Stakeholder Comments on BCG-Unresponsive Guide

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Two stakeholders recommend changes to an FDA draft guidance on treatment development for Bacillus Calmette-Guerin-Unresponsive Non...