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Human Drugs

Acer Therapeutics NDA Resubmission Accepted

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

Medical Devices

Covidien Recalls Palindrome and Mahurkar Catheters

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

Human Drugs

FDA/Patent Office Coordination Bill Advances

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

Medical Devices

FDA Oks Lenstec Segmented Bifocal Intraocular Lens

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

Federal Register

Guide on Cancer Clinical Trial Eligibility Criteria

Federal Register notice: FDA makes available a final guidance entitled Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative S...

Federal Register

Drug Outsourcing Facility User Fees Set for FY 2023

Federal Register notice FDA announces the fiscal year 2023 rates for the establishment and reinspection fees related to entities that compound human d...

Federal Register

Draft Guide on LASIK Patient Labeling

Federal Register notice: FDA makes available a draft guidance entitled Laser-Assisted In Situ Keratomileusis (LASIK) Lasers Patient Labeling Recommen...

Federal Register

Animal Drug User Fee Rates

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

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Human Drugs

Opioid Questions Continue to Dog Califf: AP

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

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Human Drugs

1st Year Generic Drug Cluster Accomplishments

FDA reviews the first-year accomplishments and future plans for the multi-country Generic Drug Cluster.