US FDA wants to work with practitioners to develop suggested prescribing standards, which could then be used to create packaging requirements.
The US FDA is interested in using opioid labels to mandate packaging standards, as well as offer claims similar to those available for abuse-deterrent products.
Commissioner Scott Gottlieb said Dec. 11 that labeling claims describing the benefits of packaging could be connected to agency efforts...
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.
