PhRMA asks FDA to consider expiration of pediatric exclusivity in requesting pediatric clinical trials; AbbVie describes eight-year effort to begin enrollment in Humira pediatric ulcerative colitis study.
Pharmaceutical sponsors are pressing the US Food and Drug Administration to more narrowly tailor its written requests for pediatric studies, while other stakeholders want the agency to take a more expansive view of its powers in the area.
The Pharmaceutical Research and Manufacturers of America urged FDA to be more cautious in its written requests for pediatric studies...
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.
