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Enantiomeric Determination of Medetomidine in Street Drug Samples (August 2024—February 2025) and Implications for Immunoassay Test Strip Analysis

Street drug samples were analyzed using LC–MS/MS to determine the isomeric composition of medetomidine. All samples were found to be racemic…

Enantiomeric Determination of Medetomidine in Street Drug Samples (August 2024—February 2025) and Implications for Immunoassay Test Strip Analysis

Street drug samples were analyzed using LC–MS/MS to determine the isomeric composition of medetomidine. All samples were found to be racemic…

Search for Pharmaceutical Quality Documents

FDA provides resources on pharmaceutical quality topics, including information on regulations, guidance documents, and compliance programs in a searchable and…

FDA Advances Rare Disease Drug Development with New Evidence Principles

FDA advanced Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability for the review of therapies intended to…

CDER/CBER Rare Disease Evidence Principles (RDEP)

CDER and CBER propose a new regulatory process for the approval of drugs to treat rare diseases with very small…

FDA-TRACK: Prescription Drug User Fee Act Meeting Goals Summary

FDA-TRACK: Prescription Drug User Fee Act Meeting Goals Summary

FDA-TRACK: Prescription Drug User Fee Act Procedural Goals Summary

FDA-TRACK: Prescription Drug User Fee Act Procedural Goals Summary

FDA-TRACK: Prescription Drug User Fee Act Review Goals Summary

FDA-TRACK: Prescription Drug User Fee Act Review Goals Summary

Identification of Tetrahydrocannabidiol Metabolites in Human Urine

The detection of Phase I and II metabolites of tetrahydrocannabidiol (H4CBD) in urine after oral ingestion of 25-mg H4CBD by…