US FDA seeks public input on potential advantages and challenges of requiring 5-, 10, and -15-count blister packs for certain opioids and the idea of staggering implementation.
The US Food and Drug Administration is considering whether to stagger a requirement for immediate release opioid blister packaging, so the most commonly prescribed products, including hydrocodone and oxycodone, would be first to be available in 5-, -10, and 15-count blister packs.
The agency gained authority to require unit-of-dose packaging for opioids under legislation enacted in October; the requirement was among the...
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.
