Improving Data Quality with Centralized Statistical Monitoring - with Dr. Paul Schuette and Xiaofeng (Tina) Wang

Audio Transcript | The Need for Artificial Intelligence in Pharmacovigilance with Dr. Robert Ball

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

An FDA Self-Audit of Continuous Manufacturing for Drug Products

The Key Elements of Being “Recall-Ready”

The ABCs of Product Specific Guidances

Improving Regulatory Communication via the CDER NextGen Portal

Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA?

Research Investigational New Drug Applications – What You Need To Know

Competitive Generic Therapies

FDA Modernizes Clinical Trials with Master Protocols