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Roche Cobas Covid/Flu Test EUA Revoked

[ Price : $8.95]

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

[ Price : $8.95]

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

Company Illegally Marketing Stem Cells: FDA

[ Price : $8.95]

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

[ Price : $8.95]

PhRMA makes nine recommendations for changes to an FDA draft guidance on the platform technology designation program.

Correct Misleading AbbVie Study Description: Ali

[ Price : $8.95]

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...

Denali Aims for Early 2025 Hunter Syndrome BLA

[ Price : $8.95]

Denali Therapeutics plans to submit a BLA early next year that will seek accelerated approval for DNL310 (tividenofusp alfa) and i...

Guidance on BIMO Data Technical Specifications

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FDA releases a guidance entitled Bioresearch Monitoring Technical Conformance Guide Technical Specifications Document that provid...