Chart encapsulates the fundamental questions in Alliance for Hippocratic Medicine v. FDA and the arguments of both parties on standing to sue, the agency’s approval standards, REMS changes, and the Comstock Act of 1873.
The landmark litigation attempting to remove mifepristone from the market involves issues central to the US Food and Drug Administration’s regulation of drug products. The outcome will impact who is able to file suit to seek reversal of a drug approval and whether courts can set aside the agency’s evaluation of scientific data.
Below are the arguments the parties made in filings with the US Court of Appeals for the Fifth Circuit. The...
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.
