Listen to Tina Wang, Statistician, and Dr. Paul Schuette, Deputy Division Director, in the Office of Biostatistics Division of Analytics and Informatics within FDA’s Center for Drug Evaluation and Research discuss FDA’s experiences with a centralized statistical monitoring tool.
Audio podcast for the pharmaceutical industry on The Need for Artificial Intelligence in Pharmacovigilance and the Emerging Drug Safety Technology Program
Considerations for Drug Products that Contain Nanomaterials
Using Bayesian statistical approaches to advance our ability to evaluate drug products
Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products
The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development
FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds
The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities
Continuous manufacturing (CM) technology has the potential to improve product quality and reliability, lower manufacturing costs, reduce waste, decrease inventory, and increase manufacturing flexibility and agility in response to product demand.
A voluntary recall is an action taken by a company to correct a violative product or remove it from the market.
Product-specific guidances (or PSGs for short) describe the Agency's current thinking on the evidence needed to demonstrate that a generic drug is therapeutically equivalent to the corresponding reference listed drug (RLD) product.
The CDER NextGen Portal (or the “Portal” for short) has made it easier than ever for regulated industry to communicate with the FDA.
Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA? | September 19, 2019 Issue
FDA recently released an update to clarify when ‘Research’ vs. ‘Commercial’ should be selected on FDA Form 1571, and thus when electronic common technical document or “eCTD” requirements would apply for an investigational new drug or “IND” application.
"FDA Modernizes Clinical Trials with Master Protocols" February 26, 2019 Issue