As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review ...
The FDA published its first draft guidance on the use of AI in the development of drugs and biological products ...
The FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, ...
On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...
After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for ...
A proposed rule to temporarily require drug testing urine samples is getting pushback from facilities that have invested in ...
The Food and Drug Administration has updated the criteria food and drink items must meet to merit a “healthy” label on ...