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Medical Devices

Medline Recalls Endotracheal Tube

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

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Medical Devices

Disclose Locked Hearing Aids: Members of Congress

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

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Human Drugs

ICH M12 Drug Interaction Guideline Out

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

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Federal Register

Anzures-Camarena Debarred Over Counterfeits

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

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Human Drugs

3 No-Longer-Marketed NDAs Withdrawn

Federal Register notice: FDA withdraws three NDAs from multiple applicants after they notified the agency that the products were no longer marketed....

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Human Drugs

FDA Oks Amgens Bkemv as Soliris Biosimilar

FDA approves Amgens Bkemv as an interchangeable biosimilar for Alexions Soliris, indicated to treat two rare diseases.

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Human Drugs

J&J Reports Positive Depression Drug Data

Johnson & Johnson reports positive topline results from its pivotal Phase 3 MDD3001 clinical trial evaluating the efficacy and safety of seltorexant a...

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Medical Devices

Lab Association Sues FDA Over LDT Rule

The American Clinical Laboratory Association and HealthTrackRX sue FDA to block the agencys final rule asserting authority over laboratory-developed t...

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Human Drugs

FDA OKs Retevmo for Pediatric Thyroid Cancer

FDA grants Eli Lilly accelerated approval for Retevmo (selpercatinib) for pediatric patients two years of age and older with advanced or metastatic me...

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Federal Register

Info Collection on Device De Novo Requests

Federal Register notice: FDA seeks comments on an OMB information collection extension entitled De Novo Classification Process (Evaluation of Automati...