The acting commissioner's statement is intended to clarify "persistent misunderstanding" about the label for the opioid overdose rescue medication's injectable formulation.
The US Food and Drug Administration is hoping a written statement, rather than a label change, will suffice as the necessary clarification that the injectable naloxone formulation is appropriate for community distribution.
Acting US Food and Drug Administration Commissioner Norman Sharpless addressed what he called "a persistent misunderstanding" that the label for...
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.
