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…
One Source Nutrition, Inc. Issues Voluntary Nationwide Recall of Vitality Capsules Due to Presence of Undeclared Sildenafil and Tadalafil
One Source Nutrition is voluntarily recalling all lots of Vitality capsules to the Consumer level. FDA analysis has found the…
Generic Drugs Forum (GDF) 2025 – 04/09/2025
Join us at the annual Generic Drugs Forum, a two-day event designed to facilitate the development and approval of safe,…
Meeting Presentations | Drugs
Meeting Presentations. CDER professionals participate in several meetings, conferences and workshops throughout the year. Appealing primarily to the pharmaceutical industry…
Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality
The New Drugs Regulatory Program Modernization’s reorganization of the Office of New Drugs (OND), with corresponding changes to the Office…