Choice All Natural, Inc. dba Om Botanical – 685615

Delivery Method: VIA UPS Reference #: 320-25-06 Product: Drugs Recipient: Recipient Name Mr. Sudhir Shah Recipient Title President Choice All Natural, Inc. dba Om Botanical 1019 Classic RoadApex, NC 27539-4402United States Issuing Office: Center for Drug Evaluation...

Update: Use of GE HealthCare EVair and EVair03 Compressors

October 29, 2024 The U.S. Food and Drug Administration (FDA) is issuing this update to inform the health care community of a change in recommendations for the GE HealthCare EVair Compressor.  Previously, on December 29, 2023, GE HealthCare issued an Urgent Medical...

CTGTAC Charter

COMMITTEE’S OFFICIAL DESIGNATIONCellular, Tissue, and Gene Therapies Advisory Committee AUTHORITYThe Cellular, Tissue, and Gene Therapies Advisory Committee (the Committee) is established under 15 U.S.C. 1451 et seq.; 21 U.S.C. 321, 341, 342, 343, 343-1, 344, 345,...

FDA grants accelerated approval to asciminib for CML

On October 29, 2024, the Food and Drug Administration granted accelerated approval to asciminib (Scemblix, Novartis AG) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). Full prescribing...