FDA is addressing regulatory reform as part of President Trump's "two-for-one" executive order, and seeks industry comments to supplement the effort.
The US FDA is calling on industry for comments about which regulations can be amended, repealed or replaced, but the agency has not given indications about which specific areas it is looking to reform.
The broader agency – along with the Center for Drug Evaluation Research (CDER) and the Center for Biologics Evaluation Research...
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.
