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FDA General

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

Bloomberg reports that Centers for Medicare & Medicaid Services head Mehmet Oz is increasingly viewed inside the Trump administration as the leading c...

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Human Drugs

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

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

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Medical Devices

FDA De Novo OK for CaRi-Heart Coronary Inflammation Technology

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

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Biologics

FDA Panel Votes Down Capricor's Duchenne Cell Therapy

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

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Human Drugs

Reviewers Concerned About Data Supporting Replimune Melanoma BLA

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

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Medical Devices

Linemaster Switch QS Violations

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

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Human Drugs

FDA: VasoCorp Selling Unapproved, Misbranded Drugs

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

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Human Drugs

PhRMA Urges FDA to Clarify Drug Dose Modeling Guidance

The Pharmaceutical Research and Manufacturers of America urges FDA to revise and clarify its draft guidance on using quantitative systems pharmacology...

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Human Drugs

Alkem Labs Plant in India Cited Over OOS Investigations, Quality Systems

FDA issues a 26-page Form 483 to Alkem Laboratories following an 4/20-5/1 inspection of the company's finished drug manufacturing facility in Daman, I...

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Human Drugs

17 Revised Draft Guidances for Certain Generic Peptide Products

FDA posts 17 revised draft product-specific guidances for peptide products, which it touts as a significant advancement in the agencys scientific and ...