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BASE10 Genetics Kit Recall is Class 1: FDA

[ Price : $8.95]

FDA says the BASE10 Genetics recall of a sample collection kit is Class 1.

CBD Qualifies as Old Dietary Ingredient: Petition

[ Price : $8.95]

The Natural Products Association asks FDA to determine that CBD is recognized as a dietary ingredient.

Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 2/18/2022.

More Product-specific Guidances for ANDAs

[ Price : $8.95]

Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide recommenda...

Info Collection Extension on CDRH Appeals Processes

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Center for Devices and Radiological He...

Electromechanical Tear Stimulator in Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies the electromechanical tear stimulator into medical device Class 2.

Integrated Continuous Glucose Monitor is Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies the integrated continuous glucose monitoring system into medical device Class 2.

Class 2 for Percutaneous Catheter for Hemodialysis

[ Price : $8.95]

Federal Register notice: FDA classifies the percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access...

BioMarin Hold Extended as FDA Seeks More Data

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FDA extends a clinical hold on BioMarin Pharmaceuticals PHEARLESS Phase 1/2 study of BMN 307, an AAV5-human phenylalanine hydroxyl...

Put Priority on Data/Technology and Staff: FDA Alliance

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The Alliance for a Stronger FDA says that commissioner Robert Califfs first priorities should focus on renewed attention to data a...