A Retrospective Cost-Effectiveness Analysis of Mifepristone-Misoprostol Medical Abortions in the First Year at the Regina General Hospital.

OBJECTIVE: In July 2017, mifepristone-misoprostol (mife/miso) became available for medical abortion at the Regina General Hospital's Women's Health Centre (RGH WHC). We investigated whether the proportion of abortions performed medically changed as a result of the introduction of mife/miso, whether using mife/miso instead of the surgical alternative would result in cost savings to the health care system, and whether abortion type differed between patients residing in and outside of Regina. METHODS: We conducted a retrospective chart review of all 306 medical abortions from the RGH WHC between July 1, 2017 and June 30, 2018. We obtained medical and surgical abortion information from that year and the preceding one from an administrative database. Statistical methods were used to calculate the costs of mife/miso, methotrexate-misoprostol (MTX/miso) and surgical abortion, as well as cost-effectiveness ratios. RESULTS: The proportion of medical abortions increased from 15.4% in 2016/2017 to 28.7% in 2017/2018 (χ21 = 54.629; P < 0.001). Calculated costs for mife/miso, with and without complications were CAD $1173.70 and CAD $1708.90, respectively, versus CAD $871.10 and CAD $1204.10, respectively, for MTX/miso, and CAD $1445.95 and CAD $2261.95, respectively, for hospital-based vacuum aspiration. At a willingness-to-pay threshold of CAD $318 (the cost of mife/miso), statistical modelling showed a 61.3% chance that mife/miso was more cost-effective than surgical abortion and a 90.8% chance that it was more cost-effective than MTX/miso. Patients from Regina were significantly more likely (χ21 = 29.406; P < 0.001) to receive a medical abortion (34.9% of abortions) than those living outside of Regina (19.6% of abortions). CONCLUSION: The proportion of abortions completed medically increased significantly over the period studied. Patients from Regina were more likely to receive medical abortion during both time periods. Mife/miso had a >50% probability of cost-effectiveness over both surgical and MTX/miso options.

Online Abortion Drug Sales in Indonesia: A Quality of Care Assessment.

This study sought to understand the experience of buying misoprostol online for pregnancy termination in Indonesia. We conducted a mystery client study August through October, 2019. Interactions were analyzed quantitatively and qualitatively, along with the contents of the packages. One hundred ten sellers were contacted, from whom mystery clients made 76 purchases and received 64 drug packages. Almost all sellers sold "packets" containing multiple drugs; 73 percent of packets contained misoprostol, and 47 percent contained at least 800 mcg of misoprostol. Thirty-four packets contained insufficient drugs to complete an abortion. When compared to WHO standards, 87 percent of sellers imparted incomplete information about potential physical effects; no seller provided information about possible complications. Women buying misoprostol from informal online drugs sellers will be underprepared for understanding potential side effects and complications. Educational activities are needed to increase women's access to information about safe use of misoprostol as a harm reduction strategy.

Regulation of the Abortion Drug RU 486: The Collision of Politics, Ethics and Morals in Australia.

The abortion drug RU 486 is widely available across the developed world, and its benefits and efficacy for women have been well established over the 40 years since its development. However, access to RU 486 for women in Australia has been a vexed issue since the mid-1990s. Because of pro-life politics under the Howard Government, importation of the drug into Australia was severely hampered, resulting in Australia lagging behind the rest of the developed world in access to medical abortions. This article highlights the history of RU 486, the current state of abortion laws in Australia and the issues that the politics of the 1990s still cause for Australian women who seek a medical abortion (especially those living remotely). Finally, it proposes some options that could alleviate some of the difficulties faced by those who seek access to RU 486.

Clinical Observation ofChanhouFujiu Decoction plus Acupuncture-moxibustion in Preventing and Treating Incomplete Drug Abortion / 上海针灸杂志

Objective To observe the clinical efficacy ofChanhou Fujiu decoction plus acupuncture-moxibustion in preventing and treating incomplete drug abortion.Method A total of 204 patients in early-stage pregnancy asking for drug abortion were randomized into group A, group B, and group C, 68 cases in each group. Group A was given oral administration of Mifeprostone and Misoprostol tablets, plus Azithromycin dispersible tablet for prevention of infection. Group B was intervened by orally takingChanhou Fujiu decoction in addition to the treatment given to group A. Group C was intervened by acupuncture-moxibustion therapy based on the treatment given to group B. The vaginal bleeding time and amount, and the recovery of menstruation in the three groups were observed after the intervention, and the clinical efficacies were compared.Result Compared with group A, the vaginal bleeding amount after drug abortion was significantly smaller (P<0.05), the bleeding duration were significantly shorter (P<0.05), and time taken for the recovery of menstruation was markedly shorter (P<0.05) in group B and C, and there were no significant abnormal conditions in the menstrual periods (P>0.05). Compared with group B, group C had significantly smaller amount of vaginal bleeding (P<0.05) and shorter duration of vaginal bleeding (P<0.05), and there were no significant abnormal conditions in the time taken for the recovery of menstruation and menstrual periods (P>0.05). The total effective rate was 75.0％ in group B and 95.6％ in group C, both significantly higher than 58.8％ in group A (P<0.05), and the total effective rate in group C was markedly higher than that in group B (P<0.05). Conclusion Chanhou Fuyuan decoction plus acupuncture-moxibustion can effectively prevent and treat complications of drug abortion, and is an effective method in preventing and treating incomplete drug abortion.

Clinical Observation ofChanhouFujiu Decoction plus Acupuncture-moxibustion in Preventing and Treating Incomplete Drug Abortion / 上海针灸杂志

Objective To observe the clinical efficacy ofChanhou Fujiu decoction plus acupuncture-moxibustion in preventing and treating incomplete drug abortion.Method A total of 204 patients in early-stage pregnancy asking for drug abortion were randomized into group A, group B, and group C, 68 cases in each group. Group A was given oral administration of Mifeprostone and Misoprostol tablets, plus Azithromycin dispersible tablet for prevention of infection. Group B was intervened by orally takingChanhou Fujiu decoction in addition to the treatment given to group A. Group C was intervened by acupuncture-moxibustion therapy based on the treatment given to group B. The vaginal bleeding time and amount, and the recovery of menstruation in the three groups were observed after the intervention, and the clinical efficacies were compared.Result Compared with group A, the vaginal bleeding amount after drug abortion was significantly smaller (P<0.05), the bleeding duration were significantly shorter (P<0.05), and time taken for the recovery of menstruation was markedly shorter (P<0.05) in group B and C, and there were no significant abnormal conditions in the menstrual periods (P>0.05). Compared with group B, group C had significantly smaller amount of vaginal bleeding (P<0.05) and shorter duration of vaginal bleeding (P<0.05), and there were no significant abnormal conditions in the time taken for the recovery of menstruation and menstrual periods (P>0.05). The total effective rate was 75.0％ in group B and 95.6％ in group C, both significantly higher than 58.8％ in group A (P<0.05), and the total effective rate in group C was markedly higher than that in group B (P<0.05). Conclusion Chanhou Fuyuan decoction plus acupuncture-moxibustion can effectively prevent and treat complications of drug abortion, and is an effective method in preventing and treating incomplete drug abortion.

Misoprostol en la interrupción temprana del embarazo en pacientes adolescentes / Misoprostol in early termination of pregnancy in adolescents

OBJETIVO: evaluar la eficacia y seguridad del misoprostol vaginal como abortivo y la indicación de este proceder en la adolescencia. MÉTODOS: nuestra investigación se trata de un ensayo clínico aleatorio, abierto, monocéntrico, con un grupo de tratamiento para extender el uso de un método abortivo farmacológico en pacientes que solicitan interrupción de la gestación hasta las 12 sem de embarazo y hasta los 20 años de edad. Se incluyeron todas las pacientes adolescentes que acudieron a la consulta de interrupción de embarazo del hospital Ramón González Coro y que cumplieron con los criterios de inclusión, en un cohorte de 100 casos. RESULTADOS: los resultados encontrados muestran que el 89 % de las adolescentes tenían más de 16 años, las primeras relaciones sexuales (76 %) fueron antes de los 16 años y las infecciones de tramisión sexual (ITS) aparecen en el 51 %. Con respecto al método el 71 % expulsó antes de las 16 h de impuesto (primera y segunda dosis) con una tasa de fallo del 8 %.Todas fueron estudiadas con US a las 72 h. El 85 % considera satisfactorio el método y 96 salieron con algún método anticonceptivo. CONCLUSIÓN: el uso del misoprostol por vía vaginal en la adolescencia resultó ser un método útil y confiable como alternativa para la interrupción del embarazo en el primer trimestre

OBJECTIVE: To assess the effectiveness and safety of vaginal Misoprostol as abortive method and indication of this procedure during adolescence. METHODS: Present research is a monocenter, open, randomized clinical trial with a group of treatment to extend the use of a pharmacologic abortive method in patients requesting pregnancy termination until the12 weeks and also until 20 years old. All the adolescent patients seen in pregnancy termination consultation of ½Ram¾n Gonzßlez Coro» Gynecology and Obstetrics Hospital fulfilling with inclusion criteria in a group of 100 cases are included. RESULTS: Results achieved show that the 89 percent of adolescents aged over 16, their first sexual intercourses were before 16 years and ITS (appear in the 51 percent. Regarding the method, the 71 percent had a expulsion rate before the 16 h of application (first and second dose) with an 8 percent failure rate. All were studied using US at 72 h. The 85 percent considers that the method was satisfactory and in the 96 percent some contraceptive method was used. CONCLUSION: The use of vaginal Misoprostol during the adolescence was a useful and reliable method as alternative for pregnancy termination at first trimester

Medical abortion method with mifepristone-misoprostol in Viet Nam

From Jan to Dec 2001, in 8 studied institutions, an internal clinical trials were performed on 1.520 women of > 18 years old, with < 57 day in uterus pregnancy, who went a medical abortion using 200 mg mifepristone and 400 mg oral misoprostol two days after. Results showed a success of this procedure on 90% of abortion women. Choosing by oneself, 88% of women preferred to choose oral misoprostol used at home and 12% at consultative room. This method of abortion is safe, effective, capable to use widely in various health care levels

Medical abortion: public health and private lives.

PIP: Induced abortion is a common event in the lives of women and their families. Statistics show that in the US nearly half of all women personally benefit from abortion; hence abortion is important from both a medical and a social standpoint. During the 1900s, anti-abortion laws were promulgated, subsequently resulting in the rise of maternal mortality due to complications from unsafe abortions. In the mid-1960s, state laws began to change to allow women access to safe abortions provided by licensed physicians. Since then, deaths from illegal abortions have decreased substantially. It is noted that legal abortion is one of the safest operations in contemporary medical practice, and its safety has improved through the years. Surgical skills have been enhanced and the technologies of suction curettage abortion and dilatation and evacuation introduced. In addition, abortion techniques using prostaglandin, mifepristone, methotrexate, and misoprostol have advanced.^ieng

Medical abortion regimens: historical context and overview.

Medical abortion offers an important alternative to surgical abortion for women with early pregnancies who wish to avoid a surgical procedure. More than 3 million women worldwide have had medical abortions in the past decade alone. The best-studied regimens include mifepristone orally followed 36 to 48 hours later by a prostaglandin analog administered either orally or intravaginally. Because of political and social restrictions related to mifepristone, however, researchers have investigated alternative regimens, most notably methotrexate and misoprostol. Mifepristone regimens are approximately 95% effective for abortion at

Medical abortion service delivery.

Medical abortion with mifepristone and methotrexate regimens may be offered in a variety of American medical practice settings. In this article the new provider will find information on all aspects of the patient care delivery system for medical abortion, including physical space requirements, staffing and training, patient flow, cost, security, marketing, and quality assurance. Because of the limited published data available regarding logistic issues surrounding abortion care, the information in this article derives largely from the experiences of providers who have established medical abortion practices in their offices or clinics. Its goals are to help make the initial start-up phase briefer and more rewarding for new providers, to offer helpful guidelines for incorporation of medical abortion into practice, and to encourage more practitioners to see the benefits of adding this option to their practices.

Counseling for medical abortion.

Counseling and education are correlated with women's satisfaction with all abortion care. They often assume a larger role in medical abortion because the patient is a more active participant in the abortion process. This article aims to enhance the practitioner's expertise in providing the information and care necessary for women considering early abortion with medical regimens. It offers general counseling guidelines and several likely clinical scenarios regarding the decision-making process, the screening of patients, and the initial and follow-up visits. Through effective communication, practitioners can provide the information and support that patients need to complete the abortion process safely and can help to strengthen women's confidence in managing their reproductive health experiences.

The roles of clinical assessment, human chorionic gonadotropin assays, and ultrasonography in medical abortion practice.

The clinical assessment of patients who request early medical abortion includes confirmation of the diagnosis of pregnancy and estimation of gestational age. Accurate gestational dating is essential, because the efficacies of medical abortion regimens decline as pregnancy advances. Whereas medical abortion researchers in the United States have relied on routine ultrasonography for gestational dating, abortion providers experienced with mifepristone and prostaglandin regimens outside the United States have reported high efficacy and safety primarily with clinical dating parameters. Diligent follow-up of patients allows clinicians to confirm that complete abortion has occurred without complications. In cases of uncertain outcome or suspected ectopic pregnancy, transvaginal ultrasonography and beta-human chorionic gonadotropin assays can assist in prompt diagnosis and management. As medical abortion with mifepristone and misoprostol becomes more prevalent in the United States, studies will be needed to further evaluate the effects of these modalities on medical abortion outcomes.

Abortion with mifepristone and misoprostol: regimens, efficacy, acceptability and future directions.

Mifepristone at a dose of 600 mg followed by 400 microg misoprostol orally has been used for early abortion by hundreds of thousands of women with success rates at 49 days' gestation. A lower mifepristone dose of 200 mg and in-home self-administration of misoprostol both appear safe and effective. Although most research protocols have used ultrasonography to confirm gestational age, the method can be provided safely without routine reliance on ultrasonography. Acceptability of the method to care providers and to patients has been high in all studies. The introduction of medical abortion into general medical practice in the United States will teach us much about the practical aspects of service provision.

Alternatives to mifepristone regimens for medical abortion.

Alternatives to regimens with mifepristone and a prostaglandin analog for medical abortion emerged because of the need for accessible, effective, and safe options in areas of the world where mifepristone was unavailable. Studies of oral or intramuscular methotrexate combined with misoprostol have demonstrated complete abortion rates in the same range as mifepristone regimens at

Management of side effects and complications in medical abortion.

Side effects are an expected part of medical abortion; some, such as pain and bleeding, result from the abortion process itself and are generally managed with orally administered analgesics and counseling. True medication side effects most commonly include nausea, vomiting, diarrhea, and warmth or chills. Complications of medical abortion usually represent an extreme or severe side effect. Large series have reported transfusion rates of <1%. Because of the infrequency of uterine instrumentation, postabortal endometritis appears to be rare with medical abortion. As with early surgical abortion, the clinician must remain aware of the possibility for ectopic pregnancy. Overall approximately 2% to 10% of patients will require surgical intervention for control of bleeding, resolution of incomplete expulsion, or termination of a continuing pregnancy. Understanding the types of side effects and complications that can occur will enable the clinician to counsel patients properly as well as to understand when medical intervention is necessary during the medical abortion process.

Acceptability of suction curettage and mifepristone abortion in the United States: a prospective comparison study.

OBJECTIVE: We sought to compare the acceptability of suction curettage abortion with that of medical abortion with mifepristone and misoprostol in American women. STUDY DESIGN: We performed a prospective, serially enrolled, cohort analysis. The study population consisted of 152 subjects receiving mifepristone and misoprostol and 174 subjects undergoing suction curettage abortion aged > or =18 years with intrauterine pregnancies of up to 63 days' estimated gestation. Questionnaires regarding expectations and experiences were administered before the abortion and at the 2-week follow-up visit. RESULTS: Subjects undergoing medical abortions reported significantly greater satisfaction than those undergoing surgical abortions (mean rank, 121 vs 149; P <.01) but were no more likely to recommend the method they had just experienced to a friend (97% vs 93.3%). If a future abortion was required, however, 41.7% of subjects undergoing surgical abortions indicated they would opt for a medical abortion, whereas only 8.6% of subjects receiving medical abortions would choose a surgical abortion (P <.001). Failure of the abortion decreased satisfaction in the medical group and increased the likelihood of choosing a surgical abortion for a subsequent procedure (P <.001). Surgical subjects who experienced more anxiety than expected during the abortion were more likely to choose a medical procedure for a subsequent abortion (P <.01). CONCLUSION: Women receiving mifepristone and misoprostol were more satisfied with their method and more likely to choose the same method again than were subjects undergoing surgical abortion. Failure of a medical abortion and increased anxiety during surgical abortion were associated with preference for the alternative technique in a future procedure.

The efficacy of medical abortion: a meta-analysis.

Multiple clinical studies demonstrate the efficacy of medical abortion with mifepristone or methotrexate followed by a prostaglandin analogue. However, assessing predictors of success, including regimen, is difficult because of regimen variability and a lack of direct comparisons. This meta-analysis estimates rates of primary clinical outcomes of medical abortion (successful abortion, incomplete abortion, and viable pregnancy) and compares them by regimen and gestational age. We identified 54 studies published from 1991 to 1998 using mifepristone with misoprostol (18), mifepristone with other prostaglandin analogues (23), and methotrexate with misoprostol (13). Data abstracted from studies included regimen details and clinical outcomes by gestational age. We found that efficacy decreases with increasing gestational age (p<0.001), and differences by regimen are not statistically significant except at gestational age > or =57 days. For gestations < or =49 days, mean rates of complete abortion were 94-96%, incomplete abortion 2-4%, and ongoing (viable) pregnancy 1-3%. For gestations of 50-56 days, the mean rate of complete abortion was 91% (same for all regimens), incomplete abortion 5-8%, and ongoing pregnancy 3-5%. For > or =57 days, success was lower for mifepristone/misoprostol (85%, 95% confidence interval 78-91%) than for mifepristone/other prostaglandin analogues 95% (CI 91-98%, p = 0.006). For mifepristone/misoprostol, using > or =2 prostaglandin analogue doses seems to be better than a single dose for certain outcomes and gestational ages. We conclude that both mifepristone and methotrexate, when administered with misoprostol, have high levels of success at < or =49 days gestation but may have lower efficacy at longer gestation.

PIP: Multiple clinical studies demonstrate the efficacy of medical abortion with mifepristone or methotrexate followed by a prostaglandin analogue. However, assessing predictors of success, including regimen, is difficult because of regimen variability and a lack of direct comparisons. This meta-analysis estimates rates of primary clinical outcomes of medical abortion (successful abortion, incomplete abortion, and viable pregnancy) and compares them by regimen and gestational age. The authors identified 54 studies published from 1991 to 1998 using mifepristone with misoprostol (18), mifepristone with other prostaglandin analogues (23), and methotrexate with misoprostol (13). Data abstracted from studies included regimen details and clinical outcomes by gestational age. The authors found that efficacy decreases with increasing gestational age (p 0.001), and differences by regimen are not statistically significant except at gestational age 57 days or more. For gestations of 49 or fewer days, mean rates of complete abortion were 94-96%, incomplete abortion 2-4%, and ongoing (viable) pregnancy 1-3%. For gestations of 50-56 days, the mean rate of complete abortion was 91% (same for all regimens), incomplete abortion 5-8%, and ongoing pregnancy 3-5%. For 57 days or more, success was lower for mifepristone/misoprostol (85%; 95% CI, 78-91%) than for mifepristone/other prostaglandin analogues (95%; 95% CI, 91-98%; p = 0.006). For mifepristone/misoprostol, using 2 or more prostaglandin analogue doses seems to be better than a single dose for certain outcomes and gestational ages. The authors conclude that both mifepristone and methotrexate, when administered with misoprostol, have high levels of success at 49 or fewer days.

Low-dose mifepristone followed by vaginal misoprostol at 48 hours for abortion up to 63 days.

The aim of this study was to compare the effectiveness, side effects, and acceptability of one-third the standard dose of mifepristone, i.e., 200 mg, and vaginal misoprostol 800 microg to induce abortion in subjects < or =56 days pregnant with subjects 57-63 days pregnant. A prospective multicenter trial enrolled healthy women > or =18 years, < or =63 days pregnant, and wanting an abortion. Women received mifepristone 200 mg orally, followed by misoprostol 800 microg vaginally, and returned 1-4 days later for ultrasound evaluation. A second dose of misoprostol was administered, if necessary. Surgical intervention was indicated for continuing pregnancy, excessive bleeding, or persistent products of conception 5 weeks later. Of 1137 subjects, 829 were in the < or =56 days pregnant group and 308 in the 57-63 days pregnant group. In all, 34 subjects had surgical intervention and 16 were lost to follow-up. Complete medical abortions occurred in 97% of subjects < or =56 days pregnant and 96% in the 57-63 days pregnant group. In all, 88% of subjects in the < or =56 days pregnant and 92% in the 57-63 days pregnant group bled within 4 h of using vaginal misoprostol. Comparing subjects < or =56 days pregnant with 57-63 days pregnant, there was less diarrhea (20% vs 29%, p = 0.002) and vomiting (33% vs 44%, p = 0.001), although side effects were acceptable to 82% of subjects in both groups. One subject in the < or =56 day group required a transfusion for delayed excessive bleeding. Although bleeding (p = 0.01) and pain (p = 0.02) were less acceptable in the 57-63 day group, 91% of subjects in both groups reported that the overall procedure was acceptable. In summary, low-dose mifepristone 200 mg and home administration of vaginal misoprostol 800 microg at 48 h were highly effective and acceptable to women < or =63 days pregnant, thereby expanding the number of women who can access a medical abortion.

PIP: The aim of this study was to compare the effectiveness, side effects, and acceptability of one-third the standard dose of mifepristone, i.e. 200 mg, and vaginal misoprostol 800 mcg to induce abortion in subjects 56 or fewer days pregnant with subjects 57-63 days pregnant. A prospective multicenter trial enrolled healthy women aged 18 years or older, 63 or fewer days pregnant, and wanting an abortion. Women received mifepristone 200 mg orally, followed by misoprostol 800 mcg vaginally, and returned 1-4 days later for ultrasound evaluation. A second dose of misoprostol was administered, if necessary. Surgical intervention was indicated for continuing pregnancy, excessive bleeding, or persistent products of conception 5 weeks later. Of 1137 subjects, 829 were in the 56 days or fewer pregnant group and 308 in the 57-63 days pregnant group. In all, 34 subjects had surgical intervention and 16 were lost to follow-up. Complete medical abortions occurred in 97% of subjects 56 or fewer days pregnant and 96% in the 57-63 days pregnant group. In all, 88% of subjects in the 56 days or fewer pregnant and 92% in the 57-63 days pregnant group bled within 4 hours of using vaginal misoprostol. Comparing subjects 56 or fewer days pregnant with 57-63 days pregnant, there was less diarrhea (20% vs. 29%, p = 0.0002) and vomiting (33% vs. 44%, p = 0.001), although side effects were acceptable to 82% of subjects in both groups. 1 subject in the 56 or fewer days group required a transfusion for delayed excessive bleeding. Although bleeding (p = 0.01) and pain (p = 0.02) were less acceptable in the 57-63 days group. 91% of subjects in both groups reported that the overall procedure was acceptable. In summary, low-dose mifepristone 200 mg and home administration of vaginal misoprostol 800 mcg at 48 hours were highly effective and acceptable to women 63 or fewer days pregnant, thereby expanding the number of women who can access a medical abortion.

Medical termination of pregnancy.

PIP: This review focuses on advances in the medical termination of pregnancy during the early period of the first trimester, when most abortions are performed. The drugs are used to terminate pregnancy act by inhibiting the synthesis of progesterone, inducing myometrial contractions, antagonizing the action of progesterone, or inhibiting trophoblast development. Among the drugs used in medical abortion are epostane, prostaglandins (including misoprostol and gameprost), combined methotrexate and misoprostol, tamoxifen-misoprostol regimen, mifepristone and prostaglandin, and antiprogestin and prostaglandins. The efficacy, side effects, and contraindications of these drugs in the medical termination of pregnancy are discussed. In general, medical abortion is associated with higher rates of prolonged bleeding, nausea, vomiting, and pain as compared to surgical abortion. However, medical termination of pregnancy has a high rate of efficacy in women with early pregnancies. In addition, medical abortion is safe and acceptable to women, and it does not require anesthesia. Lastly, women who choose medical abortion must have access to a center where suction curettage is available, should heavy bleeding occur and blood transfusion is required.^ieng

Mifepristone approval delayed, supporters look to action by FDA.

PIP: Although the US Food and Drug Administration (FDA) has again delayed action on marketing approval of the abortion drug mifepristone, supporters are using the time to continue provider training, education, and research of the medical abortion option. While FDA says it needs more information before reaching a decision on whether the drug will be made available in the US, it issued an approval letter on the mifepristone/misoprostol drug regimen, which echoed its original action of September 18, 1996. An approval letter is an action frequently used by the FDA to indicate that safety and efficacy data have passed agency review but additional information must be submitted before final approval for marketing is given. While the FDA approval process is moving forward, the National Abortion Federation (NAF) has held 12 provider training sessions this year, with presentations scheduled at several national professional provider organizations. NAF is also developing educational materials on mifepristone for patients and providers.^ieng