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
Naturista Store LLC – 701480 – 03/26/2025
Unapproved New Drugs/Misbranded
Nubratori, Inc. dba Nubratori Rx – 700513 – 01/22/2025
Compounding Pharmacy/Adulterated Drug Products
PMS4PMS, LLC – 700180 – 04/07/2025
CGMP/Finished Pharmaceuticals/Adulterated
Endogenous Nature of Hydrocortisone Acetate in Horse
A proof-of-concept study to evaluate the possible endogenous nature of hydrocortisone acetate in horses by in vitro incubation experiments using homogenized…