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.