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 ...

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

FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease ...

THE new Food and Drug Administration (FDA) application procedures are expected to reduce the drug permit process by as much as half ... “We need to build factories … because our research and ...

A research team from the University of Oklahoma has pioneered a method that could accelerate drug discovery and reduce pharmaceutical development costs. Their work, published in the Journal of the ...

One area where AI’s impact is already on display is within the clinical trial process, where its use ... the way for novel methodologies in drug development. The dynamic interplay between ...

While China’s regulatory process doesn’t uphold the patient safeguards that Americans rightly insist upon, the U.S. FDA could still streamline its path into early-stage drug development ...

However, as groundbreaking as these therapies are, they also pose unique challenges for the drug development process, particularly regarding quality assurance (QA). The role of QA is more critical ...

The study is based on a randomised controlled trial led by Professor Sylvia Gustin and Dr Nell Norman-Nott, both from UNSW Sydney and Neuroscience Research Australia (NeuRA). (Nine) Auto news ...