Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC – 654751 – 05/19/2025
Electronic Drug Registration and Listing System (eDRLS)/Violations
Infant Death due to Cannabis Ingestion
ABSTRACT A child died in the emergency room of a local hospital a few hours after ingesting a substance the…
Written Requests Issued
Updated list of approved active moieties to which FDA has issued a Written Request for pediatric studies
FDA takes steps to enhance state importation programs to help lower prescription drug prices
The U.S. Food and Drug Administration is continuing to take steps to help state importation programs provide safe, effective and…
Doping Control of Ranitidine in Horses
This article depicts the studies of in vivo metabolism and elimination of ranitidine in horse urine and plasma for doping control…
Risk Evaluation and Mitigation Strategies | REMS
A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA)…
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)
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