Postmarketing studies randomized to look at real world data sets could provide the key, Temple suggests; Amgen rep describes use of real world data to support approval of leukemia drug Blincyto.
When can real world evidence be used in lieu of a randomized controlled trial to support regulatory decisions about drugs?
A panel of regulatory and industry experts tackled the question in a featured session at the Drug Information Association's annual...
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.
