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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...

Roche Cobas Covid/Flu Test EUA Revoked

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Federal Register notice: FDA revokes a 2020 emergency use authorization granted to Roche Molecular Systems for the cobas SARS-CoV2...

Intervertebral Body Graft Devices are Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies intervertebral body graft containment devices into Class 2 (special controls).

Atlanta Doctors Research Didnt Follow Plan: FDA

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FDA warns Atlanta, GA-based physician Julio Flamini about concerns related to investigations at his Clinical Integrative Research ...

Company Illegally Marketing Stem Cells: FDA

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FDA warns Coral Gables, FL-based Mother Stem Institute about illegally marketing stromal vascular fraction products derived from d...

PhRMA Wants Changes to Platform Tech Designation

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PhRMA makes nine recommendations for changes to an FDA draft guidance on the platform technology designation program.

Correct Misleading AbbVie Study Description: Ali

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Ali Pharmaceutical asks FDA to require AbbVie to stop saying it is using Alis Armour Thyroid in a clinical trial since it is using...

Many Ideas to Approve FDA Regulation of AI: Article

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Politico explores the many ideas people have for improving FDFA regulation of artificial intelligence.

FDA Study Analyzes Provider View of Boxed Warnings

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CDER reports on research into how healthcare providers view and use Boxed Warnings when making treatment decisions for their patie...