US FDA instructed to use the "Program" when assessing insulin applications with review goals before the 2020 transition date, but appropriations report does not explicitly urge elimination of the application "dead zone."
US House appropriators addressed the so-called regulatory "dead zone" for insulin products about to switch from regulation as drugs to regulation as biologics, although not as forcefully as recently-proposed Senate legislation.
Language in the report accompanying the House fiscal year 2020 Agriculture, Rural Development and US Food and Drug Administration...
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.
