In a journal article, Center for Drug Evaluation and Research Director Janet Woodcock and colleagues describe the sources of real-word evidence and study designs that can be used to generate such evidence.
FDA made a commitment to explore the use of real-world evidence in evaluating the safety and effectiveness of medicines in its negotiations with the biopharmaceutical industry over the reauthorization of the Prescription Drug User Fee Act (PDUFA VI). With the enactment of legislation reauthorizing the user fee program, the agency is highlighting its focus on this issue.
In a viewpoint article in the Aug. 22/29 issue of the Journal of the American Medical Association, FDA's Jonathan Jarow,...
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.
