Kardesler Ucan Yaglar Sanayi Anonim Sirketi – 695413 – 01/21/2025
CGMP/Finished Pharmaceutical/Adulterated
ProRx, LLC – 696742 – 12/20/2024
Compounding Pharmacy/Adulterated Drug Products
Cost Minimized Immunoaffinity Purification of EPO and Its Analogs in Doping Control—A Step‐by‐Step Protocol for Human Urine and Blood
A cost minimized immunoaffinity protocol was developed, which allows the direct purification of ERAs from human urine. After slight modification,…
Cost Minimized Immunoaffinity Purification of EPO and Its Analogs in Doping Control—A Step‐by‐Step Protocol for Human Urine and Blood
A cost minimized immunoaffinity protocol was developed, which allows the direct purification of ERAs from human urine. After slight modification,…
About CDER Center for Clinical Trial Innovation (C3TI)
C3TI brings together collective expertise and activities to foster integration and coordination across the different ongoing projects and initiatives within…
CDER Center for Clinical Trial Innovation (C3TI)
Enable and amplify existing and future CDER clinical trial innovation through enhanced communication and collaboration
Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories
To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support…
Division of Applied Regulatory Science
The Division of Applied Regulatory Science is located within FDA’s Office of Clinical Pharmacology and tackles emerging regulatory questions and…
Provepharm Inc. Issues Voluntary Nationwide Recall of One Lot of Phenylephrine Hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) Due to Presence of Particulate Matter
Collegeville, Pennsylvania, Provepharm Inc. is voluntarily recalling lot number 24020027; Expiry Date December 2025 of Phenylephrine hydrochloride Injection, USP, 10…
Safety announcement: FDA highlights importance of DPD deficiency discussions with patients prior to capecitabine or 5FU treatment
The FDA is providing this communication to increase awareness of recent updates to the product labeling of capecitabine and fluorouracil…