Personal Importation
Personal Importation
Importing Human Drugs
FDA importing requirements for human drug products,
Navigating Controlled Correspondences to Support Generic Drug Development – 02/27/2025
Navigating Controlled Correspondences to Support Generic Drug Development
Untitled Letters
These letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion’s untitled…
TKTX Numbing Cream USA – 702106 – 02/25/2025
Unapproved New Drugs/Misbranded
Granules India Limited – 697115 – 02/26/2025
CGMP/Finished Pharmaceuticals/Adulterated
TKTX USA – 698435 – 02/25/2025
Unapproved New Drugs/Misbranded
TKTX Numb Store – 697051 – 02/25/2025
Drug Products/Adulterated/Misbranded
Hemoglobin Mass Determination: Exploring Carboxyhemoglobin Stability and Analyzer Interchangeability
ABSTRACT Carbon monoxide (CO) rebreathing is frequently used to determine hemoglobin mass (Hbmass) during hypoxic or heat training and high-altitude…
A Generic Detection Method for the Doping Control Analysis of Fc‐Fusion Proteins and Monoclonal Antibodies in Equine Plasma
A generic method for the doping control analysis of Fc-fusion proteins and mAbs in equine plasma has been developed, involving…