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Platform Tech Designation Program Guidance

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Federal Register notice: FDA makes available a draft guidance Platform Technology Designation Program for Drug Development.

NCTR Science Advisory Board Terminated

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Federal Register notice: FDA decides to terminate the Science Advisory Board to the National Center for Toxicological Research bec...

Scant Evidence for Accelerated Approval Markers: Study

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Researchers at Yale and Emory say they find little evidence to support the notion that surrogate markers used in non-oncologic dru...

FDA OKs Breyanzi in 4th Lymphoma Use

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FDA approves Bristol Myers Squibbs Breyanzi (lisocabtagene maraleucel; liso-cel) for treating adult patients with relapsed or refr...

Merck sBLA for Keytruda/Chemo in Mesothelioma

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FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) in combination with chemotherapy for the fir...

Defense-Friendly 5th Circuit Decision for Hospira

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Attorney James Beck says the 5th Circuit Court of Appeals made defense-friendly decisions in reversing several errors made by a Lo...

FDA Denies Novartis Entresto Petition

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FDA denies a 2019 Novartis petition asking for specific requirements for ANDA applicants citing Entresto as the reference-listed d...

OptumHealth Recalls Nimbus Infusion Pumps

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OptumHealth Care Solutions recalls (Class 1) its Nimbus II Plus infusion pumps due to multiple potential failure modes that may in...

Office of Regulatory Affairs, Other Changes Approved

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FDA says an agency reorganization changing the operation of the Office of Regulatory Affairs is scheduled to take effect 10/1.

Uses of and Issues with AI in Trial Design

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CDER Office of Medical Policy director Khair ElZarrad uses a podcast to discuss the benefits and challenges of using artificial in...