The agency prefers traditional clinical trials be used, but will also allow expanded access or single-patient emergency INDs for the potential coronavirus treatments.
Three familiar US Food and Drug Administration pathways are available to sponsors who wish to use convalescent plasma to treat coronavirus, although one has been modified for streamlined use.
Convalescent plasma involves use of hyperimmune globulins manufactured from concentrated pathogen-specific antibodies in plasma donated by patients that have recovered...
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.
