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Panel to Review Stealth Bio Barth Syndrome NDA

[ Price : $8.95]

Federal Register notice: FDA announces a 10/10 Cardiovascular and Renal Drugs Advisory Committee meeting to review a Stealth BioTh...

GSK Reports Trial Results of Nucala in COPD

[ Price : $8.95]

GSK says data from its Phase 3 MATINEE clinical trial evaluating chronic obstructive pulmonary disease drug Nucala (mepolizumab) m...

Odin Medical AI Colon Polyp Detector

[ Price : $8.95]

FDA clears an Odin Medical (an Olympus subsidiary) 510(k) for what it describes as the first cloud-based artificial intelligence t...

Eye Product Manufacturer Hit with Warning Letter

[ Price : $8.95]

FDA issues Regenerative Processing Plant a Warning Letter based on a 2023 inspection of the firms Palm Harbor, FL, manufacturing p...

Taenaka Kogyo Inspection Cites 4 Observations

[ Price : $8.95]

An April inspection of Japans Taenaka Kogyo ends in a four-observation Form FDA-483 that cites significant GMP violations.

Biocon Biologics Gets 10-item FDA-483

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FDA posts a Form FDA-483 issued to Biocon Biologics at the end of a July inspection at the firms Bengaluru, India manufacturing fa...

Patient Preference Info in Product Life Cycle

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FDA publishes a draft guidance on incorporating voluntary patient preference information in medical device total life cycle regula...

Info Collection on Pediatric Device Development

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Federal Register notice: FDA sends to OMB an information collection reinstatement entitled Yale-Mayo Clinic Centers of Excellence ...

Abbott Recalls FreeStyle Libre 3 Sensors

[ Price : $8.95]

Abbott Diabetes Care recalls (Class 1) three lots of its FreeStyle Libre 3 sensors after finding that a small number of them may p...

Medtronic Laryngoscope Recall is Class 1

[ Price : $8.95]

FDA says a July Medtronic recall of some McGrath MAC Video Laryngoscopes due to potential battery problems is Class 1.