Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (5th Cir. Apr. 12, 2023).pdf/7

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 * 2000 Approval|||FDA Add. 181–91|||Approved mifepristone with these REMS: (1) pregnancies under 50 days gestation; (2) three in-person office visits; (3) supervision of a qualified physician; and (4) reporting of all adverse events
 * 2002 Citizen Petition|||PI App. 280–375|||Plaintiffs’ challenge to 2000 Approval
 * 2016 Petition Denial|||FDA Add. 804–36|||FDA denial of 2002 Citizen Petition
 * 2016 Major REMS Changes|||FDA Add. 768, 777–802|||FDA changed four of the 2000 Approval’s REMS: (1) increased maximum gestational age to 70 days; (2) reduced required in-person office visits to one; (3) allowed non-doctors to prescribe and administer mifepristone; and (4) eliminated reporting of non-fatal adverse events
 * 2019 Citizen Petition|||FDA Add. 192–217|||Plaintiffs’ challenge to 2016 Major REMS Changes
 * 2019 Generic Approval|||PI App. 694–708|||FDA ANDA Approval Letter for mifepristone generic to GenBioPro, Inc.
 * 2021 Mail-Order Decision|||PI App. 713–15|||FDA announces “enforcement discretion” to allow mifepristone to be dispensed through the mail during COVID-19
 * 2021 Petition Denial|||FDA Add. 837–76|||FDA denial of almost all of the 2019 Citizen Petition, including plaintiffs’ request to keep the in-person dispensing requirements
 * 2023 Mail-Order Decision|||https://perma.cc/MJT5-35LF|||FDA permanently removed the in-person dispensing REMS
 * }
 * 2016 Major REMS Changes|||FDA Add. 768, 777–802|||FDA changed four of the 2000 Approval’s REMS: (1) increased maximum gestational age to 70 days; (2) reduced required in-person office visits to one; (3) allowed non-doctors to prescribe and administer mifepristone; and (4) eliminated reporting of non-fatal adverse events
 * 2019 Citizen Petition|||FDA Add. 192–217|||Plaintiffs’ challenge to 2016 Major REMS Changes
 * 2019 Generic Approval|||PI App. 694–708|||FDA ANDA Approval Letter for mifepristone generic to GenBioPro, Inc.
 * 2021 Mail-Order Decision|||PI App. 713–15|||FDA announces “enforcement discretion” to allow mifepristone to be dispensed through the mail during COVID-19
 * 2021 Petition Denial|||FDA Add. 837–76|||FDA denial of almost all of the 2019 Citizen Petition, including plaintiffs’ request to keep the in-person dispensing requirements
 * 2023 Mail-Order Decision|||https://perma.cc/MJT5-35LF|||FDA permanently removed the in-person dispensing REMS
 * }
 * 2021 Mail-Order Decision|||PI App. 713–15|||FDA announces “enforcement discretion” to allow mifepristone to be dispensed through the mail during COVID-19
 * 2021 Petition Denial|||FDA Add. 837–76|||FDA denial of almost all of the 2019 Citizen Petition, including plaintiffs’ request to keep the in-person dispensing requirements
 * 2023 Mail-Order Decision|||https://perma.cc/MJT5-35LF|||FDA permanently removed the in-person dispensing REMS
 * }
 * 2023 Mail-Order Decision|||https://perma.cc/MJT5-35LF|||FDA permanently removed the in-person dispensing REMS
 * }