Products with routes of administration other than oral and topical or intended to be used for the prevention or treatment of serious or life-threatening diseases and conditions will be among those prioritized for enforcement and "regulatory actions," draft guidance notes.
The US FDA will put more teeth into its homeopathic drug industry oversight under a draft guidance that identifies problems it will target for enforcement while allowing the products to remain available without pre-market approval.
The draft guidance published Dec. 18 also does not specify testing of homeopathic ingredients for certain indications but states...
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.
