Commissioner Markary announced the plans alongside the results of a generative AI pilot for scientific reviewers.

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 ...

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

The US Food and Drug Administration (FDA) has announced that all its centres will operate on a common generative artificial ...

FDA will implement a secure generative AI system across all centers by June 30, aiming to streamline internal reviews and ...

Accelerated drug development and approval pathways ... including the 2015 “Opinions on the Reform of Review and Approval Process for Drugs and Medical Devices,” and the 2020 revision of ...

The global biosimulation market, valued at approximately USD 3.1 billion in 2022, is on track to experience significant growth over the next decade. Projected to expand at a compound annual growth ...

This innovative approach aims not only to address the ethical concerns associated with animal testing but also to enhance drug safety and streamline the evaluation process. By reducing reliance on ...

Clinical trials are vital to drug development ... are transforming this process by optimizing trial protocols, enhancing recruitment, and accelerating timelines. AI and RWD Synergy: The TriNetX ...