‘Dramatic action’ needed to curb opioid epidemic, commissioner-nominee says, including potentially a cross-center approach to evaluating drugs and devices for pain, and new nomenclature for formulations currently labeled as abuse deterrent.
US FDA Commissioner-nominee Scott Gottlieb pledged to set the agency on a more activist course and “push the boundaries of the policy framework” to curb prescription opioid abuse if confirmed to the leadership post.
Enhanced scrutiny of the abuse liability for new drugs, new nomenclature around abuse-deterrent opioid formulations, and a more aggressive agency...
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.
