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Woodcock Joins Friends of Cancer Research Board

[ Price : $8.95]

Patient advocacy group Friends of Cancer Research adds former principal deputy commissioner Janet Woodcock to their board of dire...

FDA Fast Track for Heart Imaging Agent

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FDA grants Life Molecular Imaging a fast track designation to [18F]florbetaben for diagnosing cardiac amyloid light-chain and amyl...

Atara, FDA Agree on Steps to Lift Clinical Holds

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Atara Biotherapeutics says it has reached an agreement with FDA on the steps needed to lift agency clinical holds on its Ebvallo a...

Inflammatix Sepsis Molecular Diagnostic Cleared

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FDA clears an Inflammatix 510(k) for its TriVerity Test System, which it describes as a first-in-class molecular test for patients...

Multiple Incell Violations Cited

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FDA warns San Antonio, TX-based Incell Corp. about CGMP and other issues in its work as a contract manufacturer of a product deriv...

Amended Sanofi Warning Letter

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FDA issues an amended Warning Letter to Sanofis Genzyme unit in Framingham, MA, about CGMP deviations in its manufacturing of acti...

J&J Wins Monotherapy Use for Spravato

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FDA approves a Johnson & Johnson supplemental NDA for Spravato (esketamine) nasal spray for monotherapy use in treating major depr...

Biomarker Bioanalytical Method Validation

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FDA publishes a guidance on a bioanalytical method to validate biomarkers in drug and biological product applications.

7 Observations on SCA Pharmaceuticals FDA-483

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FDA releases the form FDA-483 with seven observations from an inspection at the Windsor, CT-based SCA Pharmaceuticals outsourcing ...

FDA, Other Agencies Ordered Back in Office

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President Donald Trump orders all government departments and agencies like FDA to end work-from-home arrangements and head back to...