The 21st Century Cures Act regulatory reform provisions amount to a lot of little things: tweaks to encourage ongoing activities rather than bold departures at a time when the overall regulatory climate is good for innovators. But the law could also be the start of something bigger – a more formal division within the US FDA between oncology and everything else.
The 21st Century Cures Act includes a lot of FDA-related reform provisions, but it is not a transformative piece of legislation for the agency.
The bipartisan encomiums about a new era of innovation and the howls of complaint about lowering standards from a handful...
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.
