A U.S. appeals court blocked an earlier decision suspending the FDA's approval of mifepristone, but imposed restrictions on its use.
"If allowed to take effect, the lower courts' orders would upend the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the drug, and FDA's ability to implement its statutory authority," Prelogar said.
The appeals court judges blocked mail delivery of mifepristone, re-imposed doctor visits as a condition of receiving the drug, and shortened the timeframe when women can take it to the seventh week of pregnancy. They also blocked the 2019 approval of the generic form of mifepristone made by GenBioPro.
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