Draft guidance specifies documentation that must be submitted to FDA prior to conducting an adaptive trial, and what to include in an application.
The US FDA's new draft guidance on clinical trial adaptive designs lists the information sponsors must submit to the agency before initiating a trial and what data they should include in their applications.
The agency issued the draft guidance, Adaptive Designs for Clinical Trials of Drugs and Biologics, on Sept. 28. The...
Recent studies show that spaceflight can significantly weaken astronauts’ immune systems, making them more susceptible to infections and health complications during and after missions. Understanding these changes is crucial for ensuring the safety of future long-duration space travelers.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
