FDA
FDA corrects Oxandrin withdrawal notice
FDA clarified that ANDAs referencing Oxandrin 2.5 mg and 10 mg tablets were also withdrawn for reasons of safety or effectiveness and will be removed from the Orange Book.
Read the official sourceFDA
FDA restores dimethyl fumarate ANDA to corrected withdrawal record
FDA removed ANDA 210285 from a notice withdrawing 15 ANDAs because its holder had timely requested that approval not be withdrawn. The approval remains in effect.
Read the official sourceFDA
FDA classifies focused ultrasound ablation systems
FDA classified focused ultrasound systems for nonthermal, mechanical tissue ablation as class II devices subject to special controls.
Read the official sourceFDA
FDA clears the way for pralidoxime autoinjector ANDAs
FDA determined that pralidoxime chloride autoinjector solution was not withdrawn for safety or effectiveness reasons, allowing ANDA approvals if other requirements are met.
Read the official sourceEMA
EMA adopts concept paper on pharmacogenomic practice
EMA adopted its concept paper for revising the guideline on good pharmacogenomic practice, reference EMA/282050/2025.
Read the official sourceEMA
EMA revises postauthorisation procedural advice
EMA published revision 119 of its postauthorisation procedural advice for users of the centralised procedure.
Read the official sourceEMA
EMA updates preauthorisation procedural advice
EMA published updated preauthorisation procedural advice for users of the centralised procedure, reference EMA/24037/2019.
Read the official sourceWhy this matters
Regulatory teams should verify current FDA approval and Orange Book records rather than relying on earlier notices. In Europe, the revised procedural documents warrant review against current centralised procedure practices, while the adopted pharmacogenomics concept paper signals planned guideline revision.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.