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Updates to the US Food and Drug Administration Regulations for Mifepristone: Implications for Clinical Practice and Access to Abortion.
- Source :
-
Journal of midwifery & women's health [J Midwifery Womens Health] 2017 May; Vol. 62 (3), pp. 348-352. - Publication Year :
- 2017
-
Abstract
- This article provides information on recent changes in the US Food and Drug Administration (FDA) labeling and safety regulations for mifepristone (Mifeprex). The revised label now permits midwives, advanced practice nurses, and physician assistants to order and prescribe mifepristone, eliminating the requirement for physician supervision. The updated label also extends eligibility for use from 49 to 70 days' gestation and decreases the number of required visits from 3 to 2. The recommended dose of mifepristone has been reduced, and the dosage, timing, and route of administration for misoprostol have also been changed to reflect current research. These changes have implications for clinical practice and may lead to expanded access for women in the United States.<br /> (© 2017 by the American College of Nurse-Midwives.)
- Subjects :
- Abortion, Induced methods
Drug Labeling legislation & jurisprudence
Drug Therapy, Combination
Drug-Related Side Effects and Adverse Reactions prevention & control
Female
Gestational Age
Humans
Midwifery legislation & jurisprudence
Nurse Midwives legislation & jurisprudence
Nurse Practitioners legislation & jurisprudence
Physician Assistants legislation & jurisprudence
Pregnancy
Professional Practice legislation & jurisprudence
United States
United States Food and Drug Administration
Abortifacient Agents, Steroidal administration & dosage
Abortion, Induced legislation & jurisprudence
Drug and Narcotic Control
Government Regulation
Health Personnel legislation & jurisprudence
Mifepristone administration & dosage
Misoprostol administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1542-2011
- Volume :
- 62
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Journal of midwifery & women's health
- Publication Type :
- Academic Journal
- Accession number :
- 28632953
- Full Text :
- https://doi.org/10.1111/jmwh.12636