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TXT FDA Approves GE ‘Automatic’ Anesthesia Software [234 Words] [ Price : $8.95]
FDA approves a GE Healthcare PMA for its End-tidal (Et) Control software for general anesthesia delivery on its Aisys CS2Anesthesia Delivery System.
04/05/2022
 
 
TXT FDA to Rate Drug Firms’ Quality Management Maturity [861 Words] [ Price : $8.95]
A new FDA whitepaper outlines the agency’s plans to advance a framework to objectively rate pharmaceutical manufacturing sites’ Quality Management Maturity.
04/05/2022
 
 
TXT Priority Review for Dupixent sBLA [2676 Words] [ Price : $8.95]
FDA grants priority review for Sanofi and Regeneron’s sBLA for a new Dupixent indication.
04/05/2022
 
 
TXT CGMP Issues at NDAL Mfg. [2834 Words] [ Price : $8.95]
FDA warns Monterey, CA-based NDAL Mfg. that it is manufacturing unapproved new drugs with CGMP violations.
04/05/2022
 
 
TXT Comments on FDA Immunogenicity Information Guidance [2689 Words] [ Price : $8.95]
AstraZeneca and Janssen comment on an FDA draft guidance on immunogenicity information in drug product labeling.
04/05/2022
 
 
TXT Finish Transition to Disposable Duodenoscopes: FDA [2669 Words] [ Price : $8.95]
FDA says the availability of duodenoscopes that are fully disposable or have disposable components should lead to hospitals and endoscopy facilities moving quickly to transition from non-disposable to disposable scopes.
04/05/2022
 
 
TXT Senators Want Consulting Firm Probed for Opioid Crisis [2867 Words] [ Price : $8.95]
Seven senators ask the HHS Inspector General to look into McKinsey & Company's conflicts of interest while working with FDA and the agency’s contracting procedures and practices to catch such conflicts.
04/05/2022
 
 
TXT Clinical Hold Lifted on Covid Antibody Cocktail [178 Words] [ Price : $8.95]
Immunome plans a Phase 1b trial after FDA lifts a clinical hold on its antibody cocktail (IMM-BCP-01) for treating Covid-19.
04/04/2022
 
 
TXT Panel to Mull Covid Vaccine Modifications Due to Variants [583 Words] [ Price : $8.95]
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 variants.
04/04/2022
 
 
TXT Abbott’s Leadless Pacemaker Approved for Slow Hearts [229 Words] [ Price : $8.95]
FDA approves Abbott’s Aveir VR single-chamber leadless pacemaker for treating patients with slow heart rhythms.
04/04/2022
 
 
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