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Federal Register

NCTR Science Advisory Board Terminated

Federal Register notice: FDA decides to terminate the Science Advisory Board to the National Center for Toxicological Research because it has become o...

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Medical Devices

Scant Evidence for Accelerated Approval Markers: Study

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

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Human Drugs

FDA OKs Breyanzi in 4th Lymphoma Use

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

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Biologics

Merck sBLA for Keytruda/Chemo in Mesothelioma

FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) in combination with chemotherapy for the first-line metastatic m...

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Human Drugs

Defense-Friendly 5th Circuit Decision for Hospira

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

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Human Drugs

FDA Denies Novartis Entresto Petition

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

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Medical Devices

OptumHealth Recalls Nimbus Infusion Pumps

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

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FDA General

Office of Regulatory Affairs, Other Changes Approved

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

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Human Drugs

Uses of and Issues with AI in Trial Design

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

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Human Drugs

CDER Lists 10 Pharmaceutical Quality Functions

CDER posts a list of 10 things it says people should know about the Centers pharmaceutical quality function.