MedOffice Saglik Endustri Anonim Sirketi – 687586

Delivery Method: VIA UPS Reference #: 320-25-07 Product: Drugs Recipient: Recipient Name Mr. Yucel Teker Recipient Title General Manager/Chairman of the Board MedOffice Saglik Endustri Anonim Sirketi Ic Kapi No. 1, No. 9-1 Yazibasi Mahallesi, Kuscu Caddesi35880...

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...

Regulatory Policy Information

3/19/2024 Proposed Rule Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act N/A 3/11/2024 Guidance Temporary Policies for Compounding Certain...

Duren Health Mart Pharmacy – 595524

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Jerry M. Duren Duren Health Mart Pharmacy 215 Dexter L. Woods Memorial Blvd.Waynesboro, TN 38485-2416United States Issuing Office: Division of Pharmaceutical Quality Operations II United States DATE:...