by Pill Pals | Oct 29, 2024 | News
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,...
by Pill Pals | Oct 29, 2024 | News
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...
by Pill Pals | Oct 29, 2024 | News
This recall involves updating recall instructions for using these devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue...
by Pill Pals | Oct 29, 2024 | News
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...
by Pill Pals | Oct 29, 2024 | News
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:...
by Pill Pals | Oct 29, 2024 | News
Summary Company Announcement Date: October 28, 2024 FDA Publish Date: October 28, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential Metal or Chemical Contaminant Company Name: Dynarex Corporation Brand Name: Product...
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