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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 decision has the ...
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 ] Following the Fifth Circuit's April 12 ruling, Judge Rice declared in a new order that the Fifth Circuit's stay decision does not override his order for D.C. and the 16 ...
The pharmacy certification process for mifepristone ensures that pharmacies are knowledgeable about and compliant with the REMS (Risk Evaluation and Mitigation Strategies) program.
Mifepristone was developed in 1980 and came into use in France in 1987. [16] It became available in the United States in 2000, for medication abortion, and in 2010, for Cushing's syndrome. [17] [10] [12] It is on the World Health Organization's List of Essential Medicines. [18] Mifepristone was approved in Canada in January 2017. [19] [20]
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 ]
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 idea of directing the FDA to revoke access to mifepristone is a core policy plan in Project 2025, a 900-plus page document written by conservative groups and organized by the Heritage ...