US FDA's first such guidance will focus on hemophilia, commissioner tells Congress.
The US FDA appears to be adding onto its planned slew of disease-specific guidances, with Commissioner Scott Gottlieb announcing that the agency will be releasing "a suite" of such guidances on the development of specific gene therapy documents.
Testifying before the Senate Committee on Health, Education, Labor and Pensions Dec. 7 on the agency's implementation of the 21st...
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.
