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Abbott Class 1 Recall of FreeStyle Libre Sensors

[ Price : $8.95]

Abbott Diabetes Care begins a Class 1 recall (device correction) of its FreeStyle Libre 3 sensors based on users reporting situati...

Global Calcium India Facility Hit with FDA-483

[ Price : $8.95]

An FDA inspection of a Global Calcium manufacturing facility in Hosur, India leads to a six-observation Form FDA-483 that cites si...

Patient Engagement Panel to Discuss Informed Consent

[ Price : $8.95]

Federal Register notice: FDA announces a 10/30 Patient Engagement Advisory Committee meeting that will discuss and make recommenda...

Change Platform Technology Guidance: Stakeholders

[ Price : $8.95]

Three stakeholders ask FDA to modify a draft guidance on the agencys platform technology designation guidance.

5 CGMP Observations in CARsgen Inspection

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FDA warns Durham, NC-based CARsgen Therapeutics about CGMP violations in its production of investigational drugs and biologics use...

EUA for Freeze-Dried Plasma for Military Use

[ Price : $8.95]

Federal Register notice: FDA announces the issuance of an emergency use authorization for Octapharmas freeze-dried plasma product,...

EyePoint Pharmaceuticals GCMP Violations

[ Price : $8.95]

FDA warns Watertown, MA-based EyePoint Pharmaceuticals about CGMP violations in its production of finished drugs.

Illuminas TrusSight Test OK'd as Companion Diagnostic

[ Price : $8.95]

FDA approves an llumina PMA for its in vitro diagnostic TruSight Oncology Comprehensive test for two companion diagnostic indicati...

FDA Tightens Pemgarda Covid-19 EUA

[ Price : $8.95]

FDA explains its rationale for making six changes to the emergency use authorization for Invivyds Pemgarda Covid-19 pre-exposure p...

FDA Expanding RWD/RWE Use: Marston

[ Price : $8.95]

FDA chief medical officer Hilary Marston explains in a podcast how the agency is expanding its use of real-world data and evidence...