Director Peter Marks says faster guidance development practices produced well-written documents and may be adopted once the pandemic ends.
Some of the better guidances to come out of the US Food and Drug Administration’s Center for Biologics Evaluation and Research recently were written under coronavirus-related pressure, and director Peter Marks said the lessons could lead to permanent process changes once the pandemic is over.
Among the efficiencies required for the pandemic response has been a much more truncated timeline for some guidance documents. Marks...
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.
