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Otsuka Pharmaceutical FDA-483 Released

[ Price : $8.95]

FDA releases the form FDA-483 with five observations from an inspection at the Otsuka Pharmaceutical second factory in Tokushima, ...

FDA Clears Embecta Disposable Insulin Patch Pump

[ Price : $8.95]

FDA clears an Embecta 510(k) for its Disposable Patch Pump for Insulin Delivery, intended for use by adults who require insulin to...

ADHD Digital Therapy Devices Put Into Class 2

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Federal Register notice: FDA classifies certain digital therapy devices for attention deficit hyperactivity disorder into Class 2.

Class 2 for Neuromuscular Tongue Muscle Stimulators

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Federal Register notice: FDA classifies neuromuscular tongue muscle stimulators and their use for reducing snoring and obstructive...

Feedback Sought on Model-Informed Drug Development

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CDER and CBER seek input to help advance the agencys model-informed drug development program.

FDA Authorizes Updated Novavax Covid Vaccine

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FDA grants an emergency use authorization for an updated version of Novavaxs Covid-19 vaccine that more closely targets currently ...

Emergent Bio Wins Mpox Vaccine Approval

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FDA approves an Emergent BioSolutions supplemental BLA for an expanded indication ACAM2000, (smallpox and mpox vaccine, live) to i...

FDA Backs CellProthera Cell Therapy Phase 3 Study

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CellProthera says a recent FDA meeting led to their alignment on a planned pivotal Phase 3 trial design for its ProtheraCytes cell...

Technical Modification for Device Malfunction Reporting

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Federal Register notice: FDA announces a minor technical modification to an alternative option that permits quarterly manufacturer...

Device Malfunction Summary Reporting Guide

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Federal Register notice: FDA makes available a final guidance entitled Voluntary Malfunction Summary Reporting (VMSR) Program for ...