Attorneys say the biggest step FDA could take to expand access to medication abortion would be to eliminate REMS requirement for mifepristone. Timeline notes steps Biden administration and Congress have taken since the Supreme Court’s ruling overturning the right to an abortion.
The US Department of Health and Human Services is expected to issue a report soon noting what the administration can do to expand access to medication abortion. Attorneys point to one action the US Food and Drug Administration could take to accomplish this goal: eliminate the Risk Evaluation and Mitigation Strategy for mifepristone.
On 8 July, President Biden issued an executive order on “Protecting Access to Reproductive Healthcare Services,” in which he said...
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.
