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Human Drugs

FDA Nixes Cefazolin as Surrogate Agent for Cephalosporins

FDA determines there are insufficient data to support a proposed cefazolin susceptible minimum inhibitory concentration breakpoint of less than or equ...

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Medical Devices

Warning Letter Close Out for Innova Medical

FDA closes out a Warning Letter issued to Innova Medical Group over its unauthorized Covid-19 test following a recent inspection that did not cited an...

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Federal Register

Gene Therapy Neurodegenerative Disease Guide

Federal Register notice: FDA makes available a final guidance entitled Human Gene Therapy for Neurodegenerative Diseases; Guidance for Industry.

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Human Drugs

Gormley Adds Oncology Endpoint Role at FDA

CDER Division of Hematologic Malignancies 2 division director Nicole Gormley is named acting associate director for oncology endpoint development in F...

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Medical Devices

AI Ultrasound Gains De Novo Backing for Nerve Block

FDA grants Intelligent Ultrasound a de novo marketing authorization for its artificial intelligence ScanNav Anatomy Peripheral Nerve Block for ultraso...

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Federal Register

Info Collection on Right to Try

Federal Register notice: FDA sends to OMB a proposed information collection entitled Annual Summary Reporting Requirements Under the Right to Try Act....

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Human Drugs

Catalent Brussels Plant Inspected Again

For the second time in a year, FDA inspects contract manufacturer Catalents Brussels, Belgium, manufacturing facility.

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Federal Register

Comments Extended on Non-Rx Drug Proposed Rule

Federal Register notice: FDA extends the comment period for a 6/28 proposed rule entitled Nonprescription Drug Product With an Additional Condition fo...

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Federal Register

Draft Guide on Breakthrough Devices Program

Federal Register notice: FDA makes available a draft guidance entitled Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparit...

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Federal Register

Guide on Drug Trial Multi-Endpoints

Federal Register notice: FDA makes available a final guidance entitled Multiple Endpoints in Clinical Trials.