US FDA gives 12 month grace period for ophthalmic products once regulated as drugs to comply with requirements for combination products and temporarily exempts lower-risk constituents. Guidance specifies changes agency is making in response to Genus Medical v. FDA decision.
The US Food and Drug Administration is giving manufacturers of ophthalmic drug dispensers 12 months to meet regulatory requirements for combination products.
The agency has regulated eye cups, eye droppers, and other dispensers for ophthalmic use as drugs when they are packaged...
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.
