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Dr. Oz Emerges as Potential Successor to RFK Jr. at HHS, Report Says

[ Price : $8.95]

Bloomberg reports that Centers for Medicare & Medicaid Services head Mehmet Oz is increasingly viewed inside the Trump administrat...

Dr. Reddys Gets FDA-483 After Pre-Approval Inspection

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FDA issues Dr. Reddys a three-observation Form FDA-483 following a pre-approval inspection and Good Manufacturing Practices inspec...

FDA De Novo OK for CaRi-Heart Coronary Inflammation Technology

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FDA grants de novo authorization for Caristo Diagnostics CaRi-Heart coronary inflammation technology.

FDA Panel Votes Down Capricor's Duchenne Cell Therapy

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An FDA advisory committee votes against recommending approval for Capricor Therapeutics' investigational cell therapy deramiocel, ...

New Effectiveness Evidence Requirements Analyzed

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Two Latham Watkins attorneys analyze a revised FDA draft guidance on demonstrating substantial evidence of effectiveness in drug a...

Allure Labs FDA-483 Out

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FDA releases the form FDA-483 with three observations from an inspection at the Hayward, CA-based Allure Labs drug manufacturing f...

Reviewers Concerned About Data Supporting Replimune Melanoma BLA

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FDA reviewers raise concerns about the clinical evidence supporting Replimune Group's BLA resubmission for accelerated approval of...

Linemaster Switch QS Violations

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FDA warns Woodstock, CT-based Linemaster Switch Corp. about Quality System violations in its production of medical device foot ped...

FDA: VasoCorp Selling Unapproved, Misbranded Drugs

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FDA warns Hiram, GA-based VasoCorp Inc. that it is illegally marketing misbranded unapproved new drugs.

PhRMA Urges FDA to Clarify Drug Dose Modeling Guidance

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The Pharmaceutical Research and Manufacturers of America urges FDA to revise and clarify its draft guidance on using quantitative ...