Timeline depicts the 27-year history of mifepristone from new drug application submission through an advisory committee vote, REMS changes, and legal challenges. With the product headed back to the Supreme Court, FDA's approval authority in general is also on the docket.
Mifepristone has had a tumultuous history since the US Food and Drug Administration approved the drug for medical termination of intrauterine pregnancy. Antiabortion groups have sought to restrict its use and have it removed from the market while medical groups have pushed the agency to make it more accessible.
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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.
