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SonarMed Recalls Airway Sensors

[ Price : $8.95]

SonarMed recalls its SonarMed Airway acoustic ventilator sensors due to a restricted inner diameter of the device resulting in dif...

Panel to Review Novo Nordisks Insulin Icodec

[ Price : $8.95]

Federal Register notice: FDA schedules a 5/24 Advisory Committee meeting to discuss Novo Nordisks BLA for insulin icodec.

Human Allogeneic Cell Safety Testing Guide

[ Price : $8.95]

FDA posts a draft guidance entitled Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products.

X4 Pharma Gains Xolremdi Approval

[ Price : $8.95]

FDA approves an X4 Pharmaceuticals NDA for Xolremdi (mavorixafor) and its use in patients 12 years of age and older with WHIM synd...

Clinical Pharmacology Office Priorities Docket

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Federal Register notice: FDA creates a public docket entitled Promoting Effective Drug Development: Identifying Opportunities and ...

Draft Guide on Drug Composition Statements

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FDA makes available a draft guidance entitled Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Sta...

Roivios Gets Breakthrough Status on Renal Assist

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FDA grants Roivios a breakthrough device designation for its JuxtaFlow Renal Assist Device and its use in safeguarding kidney func...

Medtronic Spinal Cord Stimulator OKd

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FDA approves a Medtronic PMA for the Inceptiv closed-loop rechargeable spinal cord stimulator for treating chronic pain.

Marks Outlines CBER 2024 Top Priorities

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CBER director Peter Marks outlines the top priorities at the Center this year that include updating the Centers tissue guidance to...

Lab Values for Cancer Trial Eligibility Guide

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Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Laboratory Valu...