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…
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)…