Accelerating drug product development and approval: a critical need in response to national emergencies
NIPTE Pathfinding Workshops
June 2024: Advanced Manufacturing Technologies: Overcoming Global Risk to the Pharmaceutical Supply Chain
January 2024: Advanced Manufacturing Technologies: Accelerating Injectable Product Development and Addressing Drug Shortages
January 2023: Accelerating Drug Product Development and Approval: a Critical Need in Response to National Emergencies
The drug discovery, development, and regulatory approval process typically take up to 15 years. This lengthy time frame makes it hard to respond to emergencies requiring new therapies, deprives patients of faster access to life-saving medicines, decreases the profitability period of pharmaceutical companies, and contributes to the high cost of new medicines. Moreover, the COVID-19 pandemic has made clear the need for faster drug development and regulatory evaluation process.