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FDA Denies Novartis Entresto Petition

[ Price : $8.95]

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

[ Price : $8.95]

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...

CDER Lists 10 Pharmaceutical Quality Functions

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

Medline Recalls Endotracheal Tube

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Medline Industries recalls (Class 1) its Medline Sub-G Endotracheal Tube with Subglottic Suctioning after complaints were received...

Disclose Locked Hearing Aids: Members of Congress

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A bipartisan group of 11 Senate and House members asks FDA to require hearing aid labeling to disclose if the device uses propriet...

ICH M12 Drug Interaction Guideline Out

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The International Council on Harmonization publishes the M12 final guideline on drug interactions and an accompanying question-and...

Anzures-Camarena Debarred Over Counterfeits

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Federal Register notice: FDA issues an order permanently debarring Maria Anzures-Camarena from providing services related to an ap...

3 No-Longer-Marketed NDAs Withdrawn

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Federal Register notice: FDA withdraws three NDAs from multiple applicants after they notified the agency that the products were n...