In this interview, rare disease expert Oxana Iliach discusses challenges with rare disease drug development and how they can ...

Food and Drug Administration Commissioner Marty Makary, M.D., spoke about the need to shorten the length of the drug approval ...

While significant progress has been made in developing treatments for rare diseases—highlighted by the approval of over 800 drugs for orphan diseases since ...

Qualification program creates a pathway to evaluate Clinical Outcome Assessments (COAs) that capture a specific concept of interest (COI) in a specified Context of Use (COU). If successfully qualified ...

DHA R&D-MRDC researchers are applying the latest regulatory guidance related to AI to better carry out their mission to ...

High-ranking OpenAI employees have met with the FDA multiple times in recent weeks to discuss AI and a project called cderGPT ...

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...

This article is authored by Aditya Sharma, head, Process Solutions, India Region, Merck Life Science, New Delhi.