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Sotrovimab No Longer Authorized Anywhere

[ Price : $8.95]

FDA says GlaxoSmithKlines sotrovimab is now not authorized for use in any HHS region because the proportion of Covid-19 cases from...

CDER Head Looks to Improved Drug Safety Surveillance

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CDER director Patrizia Cavazzoni outlines budget priorities for FY 2023, including a priority to improve drug postmarket surveilla...

FDA Approves GE Automatic Anesthesia Software

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FDA approves a GE Healthcare PMA for its End-tidal (Et) Control software for general anesthesia delivery on its Aisys CS2Anesthesi...

CGMP Issues at NDAL Mfg.

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FDA warns Monterey, CA-based NDAL Mfg. that it is manufacturing unapproved new drugs with CGMP violations.

Comments on FDA Immunogenicity Information Guidance

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AstraZeneca and Janssen comment on an FDA draft guidance on immunogenicity information in drug product labeling.

Finish Transition to Disposable Duodenoscopes: FDA

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FDA says the availability of duodenoscopes that are fully disposable or have disposable components should lead to hospitals and en...

Senators Want Consulting Firm Probed for Opioid Crisis

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Seven senators ask the HHS Inspector General to look into McKinsey & Company's conflicts of interest while working with FDA and th...

Clinical Hold Lifted on Covid Antibody Cocktail

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Immunome plans a Phase 1b trial after FDA lifts a clinical hold on its antibody cocktail (IMM-BCP-01) for treating Covid-19.

Panel to Mull Covid Vaccine Modifications Due to Variants

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FDA says an agency advisory committee will discuss 4/6 what the optimal strain composition might be for Covid-19 vaccines/boosters...

Abbotts Leadless Pacemaker Approved for Slow Hearts

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FDA approves Abbotts Aveir VR single-chamber leadless pacemaker for treating patients with slow heart rhythms.