FDA says the availability of duodenoscopes that are fully disposable or have disposable components should lead to hospitals and endoscopy facilities m...
Seven senators ask the HHS Inspector General to look into McKinsey & Company's conflicts of interest while working with FDA and the agencys contractin...
CDERs Office of Surveillance and Epidemiology (OSE) discusses new and enhanced activities in postmarketing safety reviews.
Senators Bill Cassidy (R-LA) and Tammy Baldwin (D-WI) introduce the Protecting and Transforming Cyber Health Care Act that would implement critical cy...
FDA posts a one-item Form FDA-483 for Catalent Biologics (Bloomington, IN) from a 2020 inspection at the manufacturing site.
Immunome plans a Phase 1b trial after FDA lifts a clinical hold on its antibody cocktail (IMM-BCP-01) for treating Covid-19.
FDA says an agency advisory committee will discuss 4/6 what the optimal strain composition might be for Covid-19 vaccines/boosters to address emerging...
FDA approves Abbotts Aveir VR single-chamber leadless pacemaker for treating patients with slow heart rhythms.