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CDER Reorganization Clears Congress

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CDER director Janet Woodcock says Congress has approved the Centers reorganization plan and it is being implemented.

Advisors Asked About Pediatric Singulair Neuropsych Events

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FDA asks members of two advisory committees for input on labeling options and communications strategies to address neuropsychiatri...

Janssen sBLA for Combination Darzalex Use in Myeloma

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FDA approves a Janssen Biotech supplemental BLA for use of Darzalex (daratumumab) in combination with bortezomib, thalidomide and ...

Apotex Recalls Some OTC Ranitidine Tablets

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FDA announces an Apotex recall of two strengths of generic Zantac labeled for Walgreens, Walmart, and Rite-Aid due to possible NDM...

FDA Guidance on REMS Changes Explained

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Three Drinker Biddle attorneys caution drug companies to consult a recent FDA final guidance on REMS modifications and revisions t...

Siemens AI-Rad Chest CT Software Cleared

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FDA clears a Siemens Healthineers 510(k) for three modules of its AI-Rad Companion Chest CT, a software assistant that brings arti...

FDA Expands Mavyret Indication

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FDA approves an expanded indication for AbbVies hepatitis C drug Mavyret.

Device Breakthrough Designation May be Made Public: Shuren

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CDRH director Jeffrey Shuren says FDA would like to hear from companies if they would be comfortable having the agency make medica...

Abbott Recharge-Free Neurostimulation Device OKd

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FDA approves Abbotts Proclaim XR recharge-free neurostimulation system for people with chronic pain.

Treatment Effects Higher in Accelerated Approvals: Study

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Researchers say the magnitude of treatment effects is higher among drugs and medical devices approved through accelerated pathways...