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Micro-Organospheres Show Cancer Proof of Concept: NCI

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The National Cancer Institute says researchers are expanding a study of micro-organospheres as a model to predict whether a cancer...

Acer Therapeutics NDA Resubmission Accepted

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FDA accepts for review an Acer Therapeutics NDA resubmission for ACER-001 (sodium phenylbutyrate) for oral suspension for treating...

Covidien Recalls Palindrome and Mahurkar Catheters

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Medtronics Covidien unit recalls (Class 1) its Palindrome and Mahurkar catheters due to a catheter hub defect that presents a pote...

FDA/Patent Office Coordination Bill Advances

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A bill that would establish a task force between the U.S. Patent and Trademark Office and FDA to improve communication and coordin...

FDA Oks Lenstec Segmented Bifocal Intraocular Lens

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FDA approves a Lenstec PMA for its SBL-3 IOL (Segmented Bifocal Lens), a next-generation asymmetric multifocal refractive intraocu...

Guide on Cancer Clinical Trial Eligibility Criteria

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Federal Register notice: FDA makes available a final guidance entitled Cancer Clinical Trial Eligibility Criteria: Available Thera...

Drug Outsourcing Facility User Fees Set for FY 2023

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Federal Register notice FDA announces the fiscal year 2023 rates for the establishment and reinspection fees related to entities t...

Draft Guide on LASIK Patient Labeling

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Federal Register notice: FDA makes available a draft guidance entitled Laser-Assisted In Situ Keratomileusis (LASIK) Lasers Patie...

Animal Drug User Fee Rates

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Federal Register notice: FDA sets fee rates and payment procedures for fiscal year 2023 for animal drug user fees.

Opioid Questions Continue to Dog Califf: AP

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An AP report says FDA commissioner Robert Califf is facing skepticism that the agency will address the nations opioid crisis in a ...