US FDA program's new 2020 sunset could create a bolus of designation requests to ensure they can still get a voucher if it ends.
Rare pediatric priority review voucher designation requests are expected to jump in the coming years, not because rare disease research is expected to explode, but because sponsors want to ensure they are eligible for the incentive.
Unlike its sister program for tropical diseases, the rare pediatric priority review voucher program has always had a limited operational...
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.
