Second consecutive year of record workload levels drive substantial increase in FDA's prescription drug user fee revenue target for fiscal year 2019.
A continued increase in workload, in some cases to new record levels, forced the US FDA's prescription drug user fees higher for fiscal year 2019. As a result, the program will be expected to generate more than $1bn for the first time.
For the second straight year, FDA indicated that application counts have approached record levels, while IND, efficacy supplement, and meeting...
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.
