Commissioner Gottlieb, who worked at FDA when modeling and simulation office was created and fostered growth of the techniques, expects that new drug development science office could do the same thing for biomarkers.
Commissioner Scott Gottlieb is hoping the US FDA can help grow biomarker development in the same way it fostered modeling and simulation practices.
To make that happen, a new Office of Drug Development Science is expected to be added as part of the...
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.
