In a year defined by application surges, more than 200 ANDAs were submitted in September, the last month of fiscal year 2017, likely to avoid paying a much higher application fee instituted Oct. 1.
The anticipated bolus of ANDAs from sponsors wanting to avoid a substantial increase in user fees waited until September to manifest. But it arrived nonetheless, and will likely complicate FDA's workload for the coming year.
FDA reported receiving 202 ANDAs in September, the last month of fiscal year 2017. It was the second-highest monthly total...
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.
