Warning letter objects to webpage and meeting exhibit material for excluding any risk information and suggesting mist formulation is superior to oral zolpidem products.
In just its third Rx drug advertisement enforcement action this year, the US FDA issued a warning letter objecting to promotional material for Zolpimist, the oral spry formulation of the sleep aid zolpidem, presented at a convention and on a company website.
The agency's Office of Prescription Drug Promotion (OPDP) sent the Nov. 14 letter to Amherst Pharmaceuticals LLC and...
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.
