The FDA spent more than 15 years crafting the guidelines, which are designed to do away with industry practices that downplay ...

The U.S. Food and Drug Administration ( FDA) now requires TV and radio drug ads to be clearer and more direct. The new ...

The agency’s new guidelines are created to eliminate pharmaceutical company practices that minimize or distract consumers ...

The FDA has published its long-awaited update to guidance to make sure clinical trials more closely reflect the range of patients that might be treated with a new therapy in the real world.

And the FDA is developing specific guidance around AI to address learning algorithms. Finally, the FDA has been developing a new Pre-Certification Process that will eventually allow companies to ...

to provide guidance on an evolving landscape and capitalise on the experience gained thus far. Given the drug pipeline and lessons learnt regarding trial design from previous trial failures, it is ...

In 2010, the FDA specified a new primary end point for ABSSSI of 3 days instead of the traditional test of cure. Friedland et al. used the new FDA end point in evaluating the CANVAS 1 and 2 trials.

New Drug Shows Promise in Clearing HIV from Brain July 25, 2024 — An experimental drug originally developed to treat cancer may help clear HIV from infected cells in the brain, according to a ...

Director, Drug Information Service, Robert Wood Johnson University Hospital, New Brunswick, NJ, and Clinical Associate Professor, Ernest Mario School of Pharmacy, Rutgers, The State University of ...