Interlaboratory comparison of phosphatidylethanol in dried blood spots using different sampling devices
In this article, we present the results of three rounds of interlaboratory comparison conducted in 2022 and 2023 for phosphatidylethanol…
Evaluation of spectroscopic techniques for on‐site drug testing of festival seizures
A two-fold on-site testing approach, Raman and FT-IR spectroscopy, was used to screen festival seizures. Moreover, FT-IR was combined with…
Analysis of Methyltestosterone and Testosterone Propionate in Dried Blood Spots After Transdermal Application
We developed an LC–MS/MS method to simultaneously detect methyltestosterone (MeT) and testosterone propionate (TP) in dried blood spots and a…
Detection of Transdermal Application of Testosterone to Racehorses by Analysis of Urine and Plasma
Currently there is no published pharmacokinetic information on transdermally applied testosterone in horses and whether their use could result in…
PDUFA VIII: Fiscal Years 2028 – 2032
Information related to FDA’s preparation for the seventh reauthorization of PDUFA.
Public Meeting on the Reauthorization of the Prescription Drug User Fee Act (PDUFA) – 07/14/2025
The public meeting will be held on July 14, 2025, from 9 a.m. to 2 p.m. The meeting agenda, public…
A “Pheraplex” Capsule Labeled as Desoxymethyltestosterone From the Market Turned Out to Be 17,17‐Dimethyl‐18‐nor‐5α‐androst‐13‐en‐3β‐ol
NMR and GC-MS/MS analysis revealed that the main content of a mislabeled “Pheraplex” (17a-methyl-etioallocholan-2-ene-17b-ol, DMT) capsule was 17,17-dimethyl-18-nor-5α-androst-13-en-3β-ol, a metabolite…
Evaluation of Diagnostic Sensitivity and Specificity of a New Automatized Assay for Indirect Synthetic Urine Identification
A new automatized specimen validity testing assay, directed to ‘long duration’ (LD marker) and ‘short duration’ (SD marker) urinary tract…
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…