The elevation of the US FDA’s top drug regulator, Janet Woodcock, to oversee COVID-19 response efforts is being framed a temporary step as part of the crisis response. But it is also a try-out for the most significant leadership transition in drug regulation in the US in a generation.
No one individual is responsible for all aspects of an organization as large and diverse as the Center for Drug Evaluation and Research in the US Food and Drug Administration.
But there is also no one person who has had as much impact on shaping what is the model modern...
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.
