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Clinical Pharmacology Office Priorities Docket

[ Price : $8.95]

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FDA makes available a draft guidance entitled Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Sta...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Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Laboratory Valu...

Trial Performance Status Eligibility Criteria Guide

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Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Performance Sta...

Guide on Washout Period Eligibility Criteria

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Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Washout Periods...

Elekta Recalls Disposable Biopsy Needles

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Elekta Instrument recalls its Disposable Biopsy Needles from one batch (837838839) because they possibly contain some microscopic ...

Pfizer Hemophilia B Gene Therapy Approved

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FDA approves Pfizers Beqvez (fidanacogene elaparvovec-dzkt), a gene therapy for treating adults with moderate to severe hemophilia...