Questions and Answers on Quality-Related Controlled Correspondence
Questions and Answers on Quality-Related Controlled Correspondence
Carbon Isotope Ratio Analysis of Urinary Steroids Following Extensive Cleanup and Formylation
A cleanup procedure for analysis of endogenous steroids in urine by gas chromatography–combustion–isotope ratio mass spectrometry (GC-C-IRMS) was developed, which…
Pediatric Tracking Requirements Under FDAAA
Dissemination of pediatric information resulting from pediatric studies done pursuant to FDAAA
Executive Order 14017 on America’s Supply Chains
Updates on recommendations to help shore up the U.S. pharmaceutical supply chain, as directed by Executive Order 14017 on America’s…
HS‐FET‐GC/MS‐Method Development and Validation for Analysis of 45 Terpenes—Creating a Complementary Tool for Comprehensive Profiling of Cannabis Flowers in Forensics
Legalisation of medicinal cannabis leads to an increasing complexity of specific forensic questions. Terpenes, volatile hydrocarbons with modular construction principle…
Detection of Nandrolone Decanoate and Its Metabolites in Equine Hair After Intramuscular Administration
This paper describes the detection of nandrolone decanoate and its metabolites, nandrolone and 4-estrene-3,17-dione, in mane hair collected from horses…
Further Insights Into the Metabolism of LGD‐4033 in Human Urine. Part 2. A New Minor Metabolite With Antagonistic Activity on the Androgen Receptor Can Indicate Recent Substance Intake
A novel early excreted minor metabolite of LGD-4033 was detected and coded as M8. Its presence was evaluated as an…
Metformin in the Horse: Pharmacokinetics and Detection Times Using Monte Carlo Simulations
In recent years, the detection of metformin in blood and urine samples collected from racehorses has raised concern among regulators.…
FDA Pilots Faster Clarifications to Meeting Minutes
The U.S. Food and Drug Administration today announced a pilot program designed to streamline communications with sponsors following formal meetings.
FDALabel: Full-Text Search of Drug Product Labeling
FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 150,000 labeling…