Study finds unintended consequences of FDA initiative requiring manufacturers of unapproved drugs to obtain approval or remove them from the market but FDA says study does not consider broad impact of the initiative.
FDA's strategy for dealing with drugs marketed before the 1962 law requiring them to be proven efficacious may have led to an increase in drug prices and shortages, according to a study led by Yale University School of Medicine alumnus Ravi Gupta.
The researchers examined products that fell under FDA's 2006 Unapproved Drugs Initiative (UDI), which requires manufacturers of unapproved drugs to...
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.
