Editing Mifepristone (section)

====Subsection H====
Some drugs are approved by the FDA under subsection H, which has two subparts. The first sets forth ways to rush experimental drugs, such as aggressive HIV and cancer treatments, to market when speedy approval is deemed vital to the health of potential patients. The second part of subsection H applies to drugs that not only must meet restrictions for use due to safety requirements, but also are required to meet [[postmarketing surveillance]] to establish that the safety results shown in clinical trials are seconded by use in a much wider population. Until December 2021, Mifepristone was approved under the second part of subsection H. The result is that women could not pick the drug up at a [[pharmacy]], but were required to receive it directly from a doctor. Due to the possibility of adverse reactions such as excessive bleeding, which may require a [[blood transfusion]], and incomplete abortion, which may require surgical intervention, the drug was only considered safe if a physician who is capable of administering a blood transfusion or a surgical abortion is available to the patient in the event of such emergencies.<ref>{{cite web | vauthors = Woodcock J | title = Testimony on RU-486 | work = Committee on Government Reform, House of Representatives | publisher = FDA | date = 12 May 2006 | url = https://www.fda.gov/ola/2006/mifepristone0517.html | access-date = 19 August 2006 |archive-url = https://web.archive.org/web/20060927090806/https://www.fda.gov/ola/2006/mifepristone0517.html <!-- Bot retrieved archive --> |archive-date = 27 September 2006}}</ref> The approval of mifepristone under subsection H included a [[black box warning]].