Commissioner Gottlieb announces several actions in the works to promote development of new treatments for opioid addiction, including guidance on how to establish novel endpoints.
The US FDA is upping its efforts to facilitate the development of new medications for the treatment of opioid use disorder. FDA Commissioner Scott Gottlieb announced that the agency is developing a protocol intended to support a claim that the availability of medication-assisted treatment (MAT) when a patient presents with overdose could lead to reduction in death over a population.
"Such an effort would be a first for the FDA," Gottlieb said in a Nov. 30 statement.
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.
