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House Delays FDA Budget Floor Vote

[ Price : $8.95]

House GOP leadership delay a floor vote on FDAs fiscal year 2024 budget bill until lawmakers return from their August recess.

UltraSight Ultrasound Guidance Software Cleared

[ Price : $8.95]

FDA clears an UltraSight 510(k) for its artificial intelligence-powered ultrasound guidance technology.

Contact Lens Care Product Guidance

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Federal Register notice: FDA makes available a final guidance entitled Hydrogen Peroxide-Based Contact Lens Care Products: Consume...

Guide on Drug Quality Consensus Standards

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled CDERs Program for the Recognition of Voluntary Consensus St...

Fentanyl Detection Kit Gains Clearance

[ Price : $8.95]

FDA clears a Shenzhen Superbio 510(k) for a point-of-care instrument intended for the qualitative detection of fentanyl in human u...

Panel to Review BrainStorm ALS Submission

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Federal Register notice: FDA announces a 9/27 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to discuss a BrainSt...

FDA Debars Daffin Over Covid Treatments

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Federal Register notice: FDA permanently debars Diana Daffin from providing services in any capacity to a person that has an appro...

Integrating ORA in Centers Has Risks: Analysis

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Attorney Tim Philips outlines best- and worst-case scenarios in the coming ORA reorganization.

Recall Unapproved Phenobarb Products: Sun

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Sun Pharma asks FDA to seek recalls of unapproved phenobarbitol products and notify healthcare providers and consumers of the dang...

Central Admixture FDA-483

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FDA releases the form FDA-483 with six observations from an inspection at Allentown, PA-based Central Admixture Pharmacy Services.