FDA warns Chino, CA-based Health Plus about CGMP violations in its manufacturing of finished pharmaceuticals.
Four stakeholders suggest changes to a draft FDA guidance on using electronic health records and claims data to support drug and biologic regulatory d...
FDA announces a 4/5-6 virtual public workshop entitled Study Design Considerations for Transbronchoscopic Thermal Ablation (TTA) Devices for the Treat...
The CDER Office of Prescription Drug Promotion accepts Lillys explanation of issues raised about Emgality TV ads and closes an untitled letter on the ...
FDA clears a Biotricity 510(k) for its Biotres Cardiac Monitoring Device, a three-lead holter device for electrocardiogram and arrhythmia monitoring.
FDA grants Cook Medical a breakthrough device designation for its new drug-eluting stent for below the knee use.
The RWE Alliance suggests that FDA increase communications with external stakeholders about concrete real-world evidence use cases.
FDA revises Eli Lillys emergency use authorization for bamlanivimab and etesevimab and Regenerons emergency use authorization for Regen-Cov (casirivim...