Upcoming Product-Specific Guidances for Generic Drug Product Development
This web page provides information related to upcoming new and revised product-specific guidances (PSGs) to support the development and approval…
Combination Products Performance Reports
Annual report to Congress on the activities and impact of the Office of Combination Products (OCP)
Sarfez Pharmaceuticals, Inc. – 708901 – 04/25/2025
False & Misleading Claims/Misbranded
Product Society LLC – 702927 – 05/08/2025
CGMP/Finished Pharmaceuticals/Adulterated
Wuxi Medical Instrument Factory Co., Ltd. – 701044 – 04/04/2025
CGMP/Finished Pharmaceuticals/Adulterated
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
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 NâPyrrolidino 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…