Detection of the GH analog somatrogon in sports drug testing: Immunological approaches and LC‐HRMS/MS
The detectability of the GH analog somatrogon with approved doping control immunoassays for hGH and hCG was evaluated and a…
Intelligence‐based anti‐doping via an Intelligence and Drug Testing Management (IDTM) system
The Intelligence and Drug Testing Management (IDTM), a system that can enhance drug testing analytics with related horse information and…
Simultaneous detection of three hypoxia‐inducible factor stabilizers—molidustat, roxadustat, and vadadustat—in multiple keratinized matrices and its application in a doping context
The authors present a method for the simultaneous identification and quantification of three HIF stabilizers in multiple keratinized matrices, with…
Generic Drug User Fee Amendments
FDA is soliciting general comments on GDUFA II Program Fee: List of Abbreviated New Drug Application Sponsors and Application Numbers.…
Transcriptomic Biomarkers in Blood Indicative of the Administration of Recombinant Human Erythropoietin to Thoroughbred Horses
RNA-sequencing of equine whole blood identified biomarkers linked to recombinant human erythropoietin (rhEPO)-induced erythropoiesis in thoroughbred horses. ABSTRACT Erythropoiesis-stimulating agents…
POSTPONED – Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act – 05/15/2025
Section 508 of PL 112-144 (FDASIA) requires FDA to obtain recommendations and relevant information from interested parties on the required…
The Harvard Drug Group, LLC Issues Voluntary Nationwide Recall of Certain Rugby® Laboratories Brand Eye Drops Supplied by Velocity Pharma, LLC Due to Potential Risk of Eye Infections
La Vergne, TN, The Harvard Drug Group, LLC d/b/a Major® Pharmaceutical and Rugby® Laboratories is initiating a voluntarily recall for…
List of Drug Master Files (DMFs)
The list is updated quarterly. Changes are made to the DMF activity status, DMF type, holder name, and subject.
FDA Rationale for Breakpoints Recognition Decision: Piperacillin-Tazobactam and Pseudomonas aeruginosa
FDA Rationale for Breakpoints Recognition Decision: Piperacillin-Tazobactam and Pseudomonas aeruginosa
PMS4PMS, LLC – 700180 – 04/07/2025
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