Quality Information for Applicants | Chemistry, Manufacturing, and Controls (NDAs, ANDAs, BLAs, and IND applications)
Quality Information for Applicants | Chemistry, Manufacturing, and Controls (NDAs, ANDAs, BLAs, and IND applications)
Inspection | Enforcement Resources
Inspection/Enforcement Resources
What is a Botanical Drug?
A botanical drug product is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans.…
Quality Metrics for Drug Manufacturing
Quality Metrics Data Reporting: This program will help FDA to address common quality issues in the pharmaceutical industry, address product…
Drug Master Files (DMFs)
Info helps to master FDA’s list of Drug Master Files (DMFs) and info on submission of DMFs to agency. FDA…
Catalent Indiana, LLC – 718189 – 11/20/2025
CGMP/Finished Pharmaceuticals/Adulterated
Further Insights Into the Metabolism of LGD‐4033 in Human Urine. Part 1. Structure Elucidation of Additional Important Metabolites
Well-characterized, chemically synthesized molecules related to LGD-4033 metabolism were used as analytical standards for the analysis of LGD-4033 post-administration urine…
Evaluation of an Innovative Portable Heroin Electrochemical Sensor for Empowering Forensic Laboratories
This study provides a comprehensive analysis of heroin seizures in Belgium (2019–2023) and evaluates an electrochemical fingerprinting approach for heroin…
Issue Information
No abstract is available for this article.