From Our Perspective
Insights from CDER leadership and experts on public health actions
Completed PDUFA VI Deliverables
Completed PDUFA VI Deliverables
Office of Infectious Diseases Research Activities
Overview of research needs, requests for information (RFIs), public workshops/meetings, opportunities for collaboration (this applies to RFI), notable guidances related…
How physicians interpret information about prescription drugs in scientific publications vs. promotional pieces
How physicians interpret information about prescription drugs in scientific publications vs. promotional pieces
Annual Licensure Reporting by Wholesale Drug Distributors and Third-Party Logistics Providers
Wholesale drug distributors and third-party logistics providers must be appropriately licensed and report licensure and other information to FDA annually…
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