Thanks in large part to new elemental impurities requirements, ANDA approvals are behind the pace needed to beat 2017’s record.
The US FDA must pick up its approval pace significantly if it wants to meet Commissioner Scott Gottlieb's goal of surpassing the 2017 generic drug approval total.
Thanks to a quarter where ANDA clearances plummeted, the agency could see its total full and tentative approvals finish below...
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.
