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De Novo Granted for Autism Diagnosis Aid

[ Price : $8.95]

FDA grants a de novo marketing authorization request to Cognoa for its Cognoa ASD Diagnosis Aid to help diagnose autism spectrum d...

AFib Patients with Wearable Devices Use More Health Resources: Study

[ Price : $8.95]

Researchers say that atrial fibrillation patients who use smartwatches or other wearable devices to manage their condition make gr...

Issues at Italys Steril Milano Sterilization Facility

[ Price : $8.95]

FDA says 97 medical device manufacturers may be affected by sterility issues at the now-closed Steril Milano ethylene oxide steril...

Scynexis Yeast Infection Drug Approved

[ Price : $8.95]

FDA approves a Scynexis NDA for Brexafemme (ibrexafungerp) tablets for oral use in patients with a vaginal yeast infection.

Reverse Dietary Supplement NAC Ban: Petition

[ Price : $8.95]

The Council for Responsible Nutrition says FDA should revert to its prior policy allowing NAC to be sold as a dietary supplement.

Biosimilar Program at FDA Maturing: Woodcock

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FDA acting commissioner Janet Woodcock says biosimilar product development is maturing with the help of numerous initiatives at th...

FDA Finds HCT/P Deviations at Utah Cord Bank

[ Price : $8.95]

FDA warns Utah Cord Bank about significant deviations from the regulations for human cells, tissues, and cellular and tissue-based...

OCE Soliciting Crowdsourced Research Input

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The FDA Oncology Center of Excellence says it is using crowdsourcing to generate possible research questions for agency scientific...

FDA Extends Review of Verrica Pharmaceuticals NDA

[ Price : $8.95]

FDA extends by three months its review of Verrica Pharmaceuticals NDA for VP-102 (cantharidin), a combination drug-device for trea...

CGMP Issues in DeChoker Inspection

[ Price : $8.95]

FDA warns DeChoker about Quality System regulation violations in its production of a tracheobronchial suction device.