From Kratom to Semi‐Synthetic Opioids: The Rise and Risks of MGM‐15
The commercial availability of MGM-15, a kratom-derived semi-synthetic and potent opioid, is reported. MGM-15 was quantified in a tablet formulation…
From Kratom to Semi‐Synthetic Opioids: The Rise and Risks of MGM‐15
The commercial availability of MGM-15, a kratom-derived semi-synthetic and potent opioid, is reported. MGM-15 was quantified in a tablet formulation…
Quantitative Medicine Center of Excellence (QM CoE) Educational Resources
Discover educational resources available under the Quantitative Medicine Center of Excellence (QM CoE).
New developments in regulatory QSAR modeling: a new QSAR model for predicting blood brain barrier permeability
New developments in regulatory QSAR modeling: a new QSAR model for predicting blood brain barrier permeability
Peptides, proteins, and the risks of cardiac arrythmias: A CDER study suggests that the human Thorough QT study is not needed for products comprised of naturally occurring amino acids
Peptides, proteins, and the risks of cardiac arrythmias: a CDER study suggests that the human Thorough QT study is not…
Nonprescription Drugs Advisory Committee Charter
The Nonprescription Drugs Advisory Committee advises the Commissioner of Food and Drugs or designee in discharging responsibilities as they relate…
Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications
Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications
Division of Applied Regulatory Science | Sampling of DARS Projects
Biomedical and Chemical Informatics; Adverse Event Profiling; Modeling to Inform Scheduling of Novel Substances of Abuse Potential; Chemical Structure-Activity Relationship…
CDER Statistical Studies Innovate Measures of Adhesion to Assess Generic Products
Drugs and the technologies used to deliver them evolve rapidly, and methods to evaluate them must be continually adapted to…
FDA approves selumetinib for pediatric patients 1 year of age and older with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas
On September 10, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric…