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[note 5] The Washington lawsuit had been raised due to changes in the REMS for mifepristone in January 2023, restricting the previously open access of the drug. The states argued that not only was the January 2023 REMS change too restrictive, but other parts of the current REMS were unnecessary and should be lifted. [57] [58] [59]
As the first week of 2023 rolled on, the U.S. Food and Drug Administration (FDA) quietly released new rules for the dispersal of the abortion medication mifepristone.
The pharmacy certification process for mifepristone ensures that pharmacies are knowledgeable about and compliant with the REMS (Risk Evaluation and Mitigation Strategies) program.
Mifepristone, and also known by ... The Fifth Circuit reversed parts of Kacsmaryk's injunction, but placed a temporary injunction on the 2016 REMS change to mifepristone.
A Food and Drug Administration (FDA) rule change will allow U.S. retail pharmacies to offer abortion pills directly to patients with a prescription, suspending a long-standing requirement that the ...
In 2000, GenBioPro's generic version of mifepristone was approved for medication abortion, as part of a two-drug regimen in combination with misoprostol. In 2023, GenBioPro sued the FDA to obtain a legal judgement confirming that mifepristone could continue to be sold, in spite of anti-abortion laws passed in some states.
The abortion pill mifepristone has been at the center of the political sphere since the Supreme Court eliminated the constitutional right to abortion in 2022. In late 2022, a lawsuit filed in ...
The mifepristone-misoprostol combination is, by far, the most recommended drug regimen for medical abortions, but other drug combinations are available. Misoprostol alone, without mifepristone, may be used in some circumstances for medical abortion, and has even been demonstrated to be successful in the second trimester. [ 37 ]