Citizen petition seeks review of all marketed opioids; agency is considering whether new opioids should have comparative benefit over existing drugs.
Public Citizen's call for the US FDA to halt approval of new opioids is unlikely to gain traction given the steps the agency is taking to change the framework for their approval.
Public Citizen and Raeford Brown, chair of FDA's Anesthetic and Analgesic Drug Products Advisory Committee, submitted a citizen petition...
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.
