NWL Netherlands Services B.V. – 701206 – 04/01/2025
CGMP/Finished Pharmaceuticals/Adulterated
FishMoxFishFlex/Simple Pet Health LLC – 707196 – 05/08/2025
Unapproved New Animal Drug/Misbranded
Sarfez Pharmaceuticals, Inc. – 708901 – 04/25/2025
False & Misleading Claims/Misbranded
Metabolic Identification Based on Proposed Mass Fragmentation Pathways of the Anabolic Steroid Bolasterone by Gas Chromatography Tandem Mass Spectrometry
The metabolism of bolasterone in liver microsomes and in urine samples of rats orally treated was evaluated due to no…
Identification of the Novel Synthetic Opioid N‐Pyrrolidino Isotonitazene at an Australian Drug Checking Service
Close collaboration between an Australian drug checking service and an affiliated university laboratory identifies and characterises the novel synthetic opioid…
Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program
The Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program is designed to expand DDT types by encouraging…
Drug Development Tool (DDT) Qualification Programs
Information about the mission and objectives of FDA’s Drug Development Tool (DDT) qualification programs.
Biomarker Qualification Program
The Drug Development Tools (DDT) Research Grant Cycle for Fiscal Years (FY) 2024 is now open.
FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine (Zyrtec, Xyzal, and other trade names)
FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine (Zyrtec,…
Chemical Analysis and Alkaloid Intake for Kratom Products Available in the United States
Kratom, Mitragyna speciosa, is a popular natural product in the United States to treat pain and opioid use disorder. A…