Since 2019, the Institute for Clinical and Economic Review (ICER) has published an annual Unsupported Price Increase (UPI) Report on its “assessment on drugs that experience significant price hikes without any novel clinical evidence” to guide policy making on prescription drugs. US lawmakers have shown interest in the UPI approach as a potential tool to … Continued
Learn how the FDA Modernization Act 2.0 will change the drug development landscape by allowing alternative methods to animal testing.
This white paper focuses on best practices for developing a CMC strategy for orally administered small molecule drugs
Model-Informed Formulation Development (MIFD) Increases Speed and Certainty for New and Generic Drugs
Learn the goals of EU-CTR, the challenges that drug developers face adapting to this system, and get recommendations for addressing these challenges.
Learn how modeling and simulation can help drug developers overcome the immunogenicity challenge, a major hurdle for biologics development and regulatory approval.