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.

Competitive Generic Therapies May 23, 2019 Issue

"FDA Modernizes Clinical Trials with Master Protocols" February 26, 2019 Issue