Whether to require physician education, when to limit the doses prescribed to patients, and how to weigh societal abuse potential in approvals are the initial questions for the Opioid Policy Steering Committee.
US FDA Commissioner Scott Gottlieb's announcement of an Opioid Policy Steering Committee raises the possibility of something like a Nixon-goes-to-China moment for the agency – bringing FDA closer to regulating the practice of medicine and weighing the societal impact of drug reviews than anyone might have expected, especially from a Republican administration.
In a May 23 all hands memo and similar public blog post, Gottlieb described the opioid epidemic in the evocative...
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.
