MuUnited States, nhoroondo yekuvhara kwekukurumidza inokonzera kukakavadzana , kupesana kwemakwikwi ezvematongerwe enyika uye yakagadzira mhosva. Izvo zvinotyisa zvekudzivirira kubata pamuviri zvinokonzerwa, pane chikamu, kuti kana vanhu vasingatendi here kuti mapiritsi emangwanani anotevera anoita kuti kudzivirira kubata pamuviri kurege kuitika kana kuti kunogumisa kubata kwatotangwa.
Ronga B Chimwe Chete (kureva,, mapiritsi emangwanani) inowanzovhiringidzwa ne RU486 (kureva, kubvisa pamuviri piritsi). Iyi mishonga miviri haina kufanana uye imwe neimwe inoshanda zvakasiyana zvachose kana inosvika pakugadzirwa kwekuberekwa.
Hazvinei kuti chii chaunotenda iwe pachako, nhoroondo yekubata pamuviri nokukurumidza uye kubvumirwa kwayo kweDAA muUnited States kwave kuri rwendo rwakanyanya. Midzi yemazuva ano inobata pamuviri inogona kukurumidza kuwanikwa kumashure ezvipfuwo muma1920, asi kushandiswa kwevanhu kwakatanga muma1960. Saka buckle up, iyi inogona kunge inotyisa ...
Muenzaniso: Nhoroondo yeEpersence Contraception
- Mid-1960: Emergency contraception yakashandiswa sechirwere chekubatwa chibharo kuitira kudzivirira kubata pamuviri usina kutarisirwa . Vanachiremba vaizopa chirwere chakanyanya chestrogen mushure mekubata chibharo. Kunyangwe izvi zvakawanikwa zvichibudirira, kwaivawo nehuwandu hwakaoma.
- Pakutanga kwema1970: Yuzpe regimen yakatangwa, iyo yakave nemasanganiswa ehomoni inoshandiswa uye yakatsiva yakakura-dose inonzi Estrogen yekudzivirira kubata pamuviri kwema1960.
- Gore ra1970 rapera : Vanachiremba vakatanga kupa mhangura yehuni seyo chete isina maitiro ekuronga kubata pamuviri.
Kufambira Mberi Kwemakore makumi maviri ...
- February 25, 1997: Nechinangwa chokukurudzira vanogadzirisa kuita zvirongwa zvekudzivirira kwekukurumidzira, FDA yakatumira muDhipatimendi reRussia iyo Komisheni, "yakagumisa kuti dzimwe dzakabatana zvekudzivirira pamuviri zvine ethinyl estradiol uye norgestrel kana levonorgestrel dzakachengeteka uye dzinoshanda kushandiswa postcoital njodzi yokudzivirira kubata pamuviri " uye kuti FDA inokumbira " kutumirwa kwemishonga mishonga yemishonga yekushandiswa uku. "
Sangano racho rinowedzera kuti rinobvumirana neJune 28, 1996 FDA Advisory Committee iyo yakabatana yakagumisa kuti kushandiswa kwemitemo mina yemasimoni inogona kushandiswa nekuchengetedza kushandiswa kwepabonde -kupa kubvumidzwa kwayo kwe "off-label" kushandiswa kwekukurumidza kwekudzivirira kubata kuzviraramisa kuberekwa mapiritsi ane .05 mg ye ethinyl estradiol uye .50 mg ye norgestrel (2 mapiritsi zvino / 2 mapiritsi mumaawa gumi nemaviri); .03 mg ye ethinyl estradiol uye .30 mg yeorgestrel (4 mapiritsi zvino / 4 mumawa gumi nemaviri) ;. 03 mg ethinyl estradiol uye.15 yevonorgestrel (4 mapiritsi zvino / 4 mumaawa 12); uye .03 mg ye ethinyl estradiol uye .125 mg yevonorgestrel (4 mapiritsi zvino / 4 mumaawa gumi nemaviri). Panguva iyoyo, FDA yakapa mirayiridzo yekuti mapiritsi anotevera aigona kushandiswa sei sekudzivirira kwekukurumidza: Ovral, Lo / Ovral, Nordette, Levlen, Triphasil, uye Tri-Levlen.
Zvisinei, iyo FDA yakataura zvakare, mu Federal Federal Statement, kuti yairamba chikumbiro chemunyika yaNovember 1994 ichikumbira sangano kubvumira vatori veimwe kusanganiswa kwekuberekwa kwepiritsi mapiritsi kuti vachinje mazita avo ekuisa mazano ekushandisa mapiritsi sekukurumidza kubata pamuviri .
- Svondo 2, 1998: The Preven Emergency Contraception Kit yakava yekutanga kugadzirwa kweDAA chaiyo chaiyo yekuvhara pamuviri nokukurumidza. Yakarongedzwa mushure mekutonga kweYuzpe, Chirongwa Chekudzivirira Emergency Contraception Kit chaiva nemuedzo wekubata pamuviri wemuviri, nhanho-nhanho "Patient Information Book" uye mapiritsi mana (rimwe nerimwe rine 0.25 mg yeevonorgestrel uye 0.05 mg ye ethinyl estradiol) - 2 kuti ive kutorwa pakarepo uye 2 kutorwa maawa gumi nemaviri gare gare. {* Cherechedza: iyi kitambo haisisipo.}
- Musi waJuly 28, 1999: FDA inogamuchirwa Plan B senzira yekutanga yeprogestin-yega yekudzivirira kubata pamuviri inowanikwa muUnited States.
- February 14, 2001: Chirongwa Chekodzero Dzakaberekwa chinoshandisa Chikumbiro cheCitizen pamwe neRADA panzvimbo yemasangano ehutano nehutano anopfuura makumi manomwe ehutano kuita Plan B inowanikwa pane-the-counter.
- Kubvumbi 21, 2003: Barr Laboratories (iyo yakagadzirwa neChirongwa B) inotumira chibvumirano neDFA kuti ichinje Plan B kubva kune chiremba kuenda kune imwe nzvimbo isinganyorwa.
- December 2003: Chikumbiro uye deta kubva kune zvidzidzo zvinopfuura makumi mana zvakaongororwa nemakomiti maviri eDAA mazano, Reproductive Health Drugs committee uye Nonprescription Drugs committee, avo vose vakabvumirana kuti Plan B yakanga yakachengeteka uye inoshanda. Dare re FDA rinotora 23-4 kuti rikurudzire kuti chirongwa B chingatengeswa pamusoro pe-counter. Vashandi veDFA vezvemhizha, kusanganisira John Jenkins, mutungamiri weHofisi yeDaily Drugs, zvakare vakabvumirana nemazano.
Anenge 6 Mwedzi Gare gare ...
- May 2004: FDA yakabudisa tsamba kuBarr Laboratories, ichiramba kudai kwekambani yekutengesa yeOTC uye ichitaura nezvekunetseka pamusoro pehutano hwevechidiki nekuita zvepabonde. Ichisarudzo chakaitwa pasinei nekuongorora kwakaratidza Hurongwa B kushandiswa kwaisaita kuti kuwedzera kusvibiswa kana kuchinja kushandiswa kwevakadzi kune dzimwe nzira dzekuberekwa kwekuberekwa . Izvi zvinotungamirirwa neRDA kusazvidza ruzivo rwezvesayenzi uye pfungwa dzezvenyanzvi dzakaunza moto kubva munharaunda yezvesayenzi. IAmerican College yezvipfeko uye veGynecologists vakatumidza chisarudzo "tsika dzinopesana" uye "tsvina yakaipa pamusoro pezita rehuchapupu hunotungamirirwa nesangano seDA."
- June 15, 2004: Senatori Patty Murray naHillary Clinton vakakumbira kuti General Accountability Office (GAO) inotanga kuongororwa muna FDA yaMay 2004 kurambwa kweBarr Laboratories sangano rekuita Plan B iripo pasina mishonga.
- July 2004: Barr Laboratories yakapa shanduro yakarongedzwa yakaenderana neya FDA's recommendation kuti iongorore hutachiwana hweHTC hwevakadzi vane makore gumi nematanhatu kana kupfuura. Zvirongwa zveDAA zvechisarudzo chinoitwa naJanuary.
- Nyamavhuvhu 2004: Chiitiko chekuongorora chirongwa chekudzivirira kwepabonde mumagazini, American Family Physician inotsanangura kuti "FDA yakagadzirisa marashi gumi nematanhatu emakwenzi ekudzivirira pamuviri nekuchengetedza nekushanda kana yakashandiswa pakubata pamuviri nokukurumidza" uye akawedzera Alesse, Levlite, Levora, Trivora, Ogestrel, Low Ogestrel, uye Ovrette kuenda kune yekutanga yaFebruary 1997 FDA runyorwa rwepiritsi ingashandiswa se-off-label chirongwa chokudzivirira chirwere.
The Plot Thickens in 2005 ...
- January 2005: I FDA yakanga isati yaita chisarudzo pamusoro pekushandurwa kweBar Labor Laborories. Zvichimirira chisarudzo, Senators Patty Murray, naHillary Clinton vakabatanidzwa pakusarudzwa kwaLester Crawford kuti vashumire seDa Commissioner. ICenter for Rights Reproductive inofanirwa zvakare kukanganisa mhosva ye FDA nekuda kwekukundikana kusangana nemitambo yayo yeJanuary uye nekuregeredza chizivo uye kubata chirongwa B kune imwe yakasiyana nedzimwe mishonga.
- Nyamavhuvhu 2005: Senators Clinton naRurray vakasimudzira tsvimbo yavo kuCrawford (uyo akazosimbiswa neSeneate) mushure mekunge Munyori wehutano neHuman Services Michael Leavitt akavimbisa kuti FDA ichaita chisarudzo musi waSeptember 1, 2005.
- Gumiguru 26, 2005: Panzvimbo yekuzivisa chisarudzo pamusoro pekushandiswa kwakaitwa, FDA yakarambidza chisarudzo chayo, ichida kubvumira kuwanikwa kwevanhu. Komisheni weCrawford akabvuma kuti "inowanika yesayenzi data yakakwana kutsigira kushandiswa kwakachengeteka kweChirongwa B sepamusoro pezvakagadzirwa," asi FDA ichiri kukundikana kubvumira kuwanikwa kweOTC, pane kusarudza kudzorerazve chisarudzo zvakare. Crawford akataura kuti sangano racho haringagoni kusvika pane chisarudzo pamusoro pemvumo yekushandira kusvikira "kusagadziriswa kwekutonga uye nyaya dzezvematongerwo enyika" zvingadzokororwa zvakare. Kunyange zvazvo FDA's expert panel yakagamuchira dambudziko reOTC yePurogiramu yevhoti 23 kusvika ku4, Crawford achiri kusarudza kupfuudza mapoka ake uye kuchengeta Plan B semishonga yemishonga.
- Svondo 1, 2005: Mubatsiri weDFC Commissioner for Women's Health, Dr. Susan Wood akazvimirira pakuratidzira chisarudzo chaCarwford kuti anonoke kugadzira chisarudzo zvakare. Dr. Wood akati "vashandi vezvesayenzi [paDFA] vakavharirwa kunze kwechisarudzo ichi" uye kuzivisa kwaCrawford, "kwakave kusinganzwisisiki kusinganzwisisiki mukugadzirisa kusarudzo kwehurumende." Mubvunzurudzo inotevera, Dr. Woods akatsanangura kuti vangani vashandi vake "vane hanya zvikuru nehutungamiri hwebazi," uye mune email kune FDA vashandi pamwe nevashandi, akaruramisa kusarura kwake achiti "iye, haakwanisi kushanda sevashandi kana masayenzi uye zvipatara zvehupatidzo, zvakaongororwa zvizere uye zvakarumbidzwa nokuda kwekugamuchirwa nevashandi vehupfumi pano, yave ichinyanyiswa. "
- Svondo 9, 2005: Senators Murray naClinton, avo zvino vakabatanidzwa nevamwe vavo 11 muUnited States Senate, vakadana United States GOA kuti vasunungure zviwanikwa zvekutsvakurudza kwayo kuongorora FDA kuramba chirongwa B. Mutsamba yavo kuenda kuGao, senamende vanotaura kuti vane hanya nemakore maviri, uye FDA inoramba ichikanganisa chirongwa cheB plan B. Izvi zvinokurudzirwa zvakapiwa nekuti masangano makuru ezvehutano anopfuura 70 anotsigira kushandiswa kweOTC kweParamende B, iyo inowanikwa yesayenzi yekusimbiswa kwemashoko kushandiswa kwakachengeteka kweGurongwa B seMutambo weOTC, uye sangano reDavi rekupa mazano rezvesayenzi rakasarudza zvikuru mukufarira chibereko chiri inowanika OTC. Vakuru ve senenasi vanonyora kuti, "Izvi zvinoitika zviitiko zvinokonzera kusimba kwakasimba kunobata nezvematongerwo enyika kwakawedzera zvinetso pamusoro pehutano hwevanhu mune izvi."
- Svondo 24, 2005: Mwedzi miviri chete mushure mekusimbiswa, Commissioner Crawford anosununguka.
- Gumiguru 2005: Dr. Frank Davidoff, aichimbova nhengo yeChirongwa cheDare reAraprescription Drugs Advisory Committee, akazvitsaurirawo mukupikisa. The New England Journal of Medicine yakabudisa mharidzo yayo yechipiri, ichiraira FDA nekuita "kuseka kwekuongorora kuongorora uchapupu hwezvesayenzi." "GAO inodana kuti FDA inoshandisa chirongwa cheB " zvisingawanzozivikanwi, " zvichiita kuti Sen. Clinton ataure kuti iyo mhinduro " inoratidzika kusimbisa izvo zvatakambofungidzira kwenguva yakati: Sayenzi yakanyengedzwa mukugadzirisa kwekuita mazano kweDAA pachirongwa B. "
Whew ... 2005 yakanga yakaoma kwazvo munhoroondo yekudzivirira kubata pamuviri. Chii gore ra2006 chave chakachengeterwa mapiritsi emangwanani-shure?
2006 kusvika muna 2013
- March 2006: Andrew von Eschenbach, shamwari uye aimbova chiremba waGeorge W. Bush, anotorwa kuti atore Crawford uye anogadzwa kuti ashande seChishanu Commissioner. Ari pasi pehutano hwake, akabudisa pepanhau rekukanganisa rinobatanidza kubvisa pamuviri uye kenza yemazamu. Senatori Clinton naRurray vanovimbisa von Eschenbach svimbiso semukuru weDFA vachimirira chirongwa cheB plan B.
- Gumiguru 9, 2006: FDA inoramba Chikumbiro cheCitizen ya2001 kwekutanga.
- Nyaya 2006: VaDFA vanoti mitemo mitsva haifaniri kutarisirwa, uye zuva rakasati rasimbiswa kuti anzwe, achiita FDA Commissioner Andrew von Eschenbach arikumbira pachena kuti Barr Labs agadzirise uye adzore kushanda kwayo nekuchinja mutemo weOTC weGwaro B kusvika kune 18 nekure .
- Gunyana 24, 2006: FDA yakaratidza kubvumirwa kwayo kwekutengeswa kweChirongwa B OTC kune avo vane makore gumi nemasere kana apfuura asi avo vaduku vanopfuura 18 vacharamba vachida mishonga kuti vawane nzira iyi yekukurumidza kubata pamuviri.
- November 2006: Barr akatanga kutumira zvisiri prescription mapeji eParamende B kune mapetimasi kumativi eSouth America.
Kufambira Mberi Kwemakore 2 ...
- Musi waDecember 23, 2008: Teva Pharmaceutical Industries inozivisa kuti inowana Barr. Purogiramu B ikozvino inotengeswa neDuramed Pharmaceuticals, iyo inowanikwa neTeva.
And the Saga Heats Up Again 3 Months Later ...
- March 23, 2009: MuTummino v. Torti , Federal Court mutongi Edward Korman akarayira FDA kubvumira vana vane makore 17 kuti vawane chirongwa B OTC pasi pemamiriro ezvinhu akadai zvaive atowanika kuvakadzi vane makore 18 nekure. Vaya vanopomerwa munyaya iyi vakaramba kuti FDA yakaramba Kurudziro yeCitizen ya2001 yaive " yakashandura uye isina kugadziriswa nokuti yakanga isiri mugumisiro wekufunga uye sangano rekutenda sangano rekuita mazano." Mutongi Korman akabvuma uye akataura kuti kufunga kwe FDA kusina kuvimbika uye kuti sangano rinopinza zvematongerwe enyika musati hutano hwevakadzi. Akakumbirawo FDA kuti iongorore zvakare kukanganisa kweCitizen Petition.
- Musi waApril 22, 2009: Nemhaka yehurumende yepamutemo inorayira FDA kubvumira vane makore 17 kuti vatenge Plan B, FDA inovhiringidza vanhu vose nekuzivisa kuti vane makore 17 vanogona kutenga Plan B OTC. Asi, ichi chiziviso ichi chakanga chave chaiva FDA ichizivisa kuti yakazivisa muiti weChirongwa B iyo kambani inogona, pakutumirwa uye kubvumira kushanda kwakakodzera , mutengo Wematongerwo B B asina mutemo kuvakadzi vane makore gumi nemashanu kana kupfuura. Ichi chiziviso chinokonzera kusununguka kwepabonde kwekukurumidza kuwana nzira yadzo yekudzoka muchivara.
- June 24, 2009: FDA inobvumirana nemutemo-kushandiswa chete kweChishanu Chokuita , shanduro yeGeneral B.
- Gunyana 13, 2009: Dhiyabhorosi yakaratidza kugamuchirwa kweChirongwa B Chimwe Chete (piritsi imwe chete yepiritsi uye shanduro itsva yeChirongwa B). Panguva ino, iyo FDA yakave yakawedzera hutano hweHTC, zvichibvumira vakadzi nevarume vane makore gumi nemashanu kana kupfuura kutenga Purogiramu B Chimwe Chetatu pamakambani ezvinotengesa mishonga pasina mutemo pavanenge vachiongorora makore (avo vanopfuura pasi 17 vanoda mushonga).
- Gumiguru 28, 2009 : FDA inobvumira kutengesa kweOTC yeChoice Choice, maitiro ezvigadzirwa zveParamende B, kune vose vane makore 17 kana kupfuura (vasikana 16 uye vaduku vanoda chiremba kuti vawane Inotevera Chokuita).
- Nyamavhuvhu 2009: Gadziriro B Chimwe Chiito chinowanikwa kune maparammita ekutengesera munyika yose, nekugadzirwa kweChirongwa chekare B.
2009 yakaratidza kuva gore guru mumamiriro ekudzivirira kubata pamuviri. Ngatitungamirire mberi kwegore rimwe gare gare ...
- August 16, 2010: The FDA inopa chigumo chekupedzisira kune itsva inobata pamuviri, Ella . Ella inongowanikwa chete nemishonga uye yakatanga kuwanika pamishonga yemapurisa kumativi aDecember 2010. Inoshanda zvakasiyana zvakasiyana neChirongwa B Chekutanga.
Iye zvino, Gadzirira Read 2011 (Sparks Ignite, Once Again) ...
- February 7, 2011: Teva Pharmaceuticals yakabudisa chikwata chekuwedzera chemishonga ekuwedzera pamwe neDFA ichikumbira kuti chirongwa B Chimwe Chengetedzo chizotengeswa pamusoro pe-counter, pasina mitsindo yezera (uye yaisanganisira mamwe mashoko anotsigira kuchengetedzwa kwayo kwemakore ose anoshandiswa).
- Dheuteronomio 7, 2011: Dhiyabhorosi yakasarudza kupa Chikumbiro cheTeva Pharmaceutical yekusimudza zviyero zvose zvezera uye kubvumira Plan B One Step kuti inotengeswa pamusoro pe-counter, pasina mishonga. Zvisinei , pane imwe nzira isati yamboitwa, Dhipatimendi reHutano neHuman Services Munyori Kathleen Sebelius anodarika mutemo weDFA uye anorayira sangano kuti rambe chikumbiro chaTeva. Sebelius anotsanangura dambudziko rakakwana kuti ribatsire kubvumira Purogiramu B One-Step kuti inotengeswa pamusoro pe-counter kune vose vasikana vezera rekubereka. Akatsanangurawo kuti vasikana vari vaduku se 11 vari mumuviri vanogona kuva nevana uye havana kunzwa kuti Teva yakaratidza kuti vasikana vaduku vaigona kunyatsonzwisisa kuti vangashandisa sei chigadzirwa kunze kwekutungamirirwa kwevakuru. Iyi sarudzo yakasimbisa zvinozvinodiwa zvinorongwa neChirongwa B Chimwe Chete (pamwe chete neChoice Choice) chinofanira kutengeswa kumashure kwemaresitorendi mabhuku mushure mekunge mhizha anokwanisa kuona kuti mutengi ane makore gumi nemashanu kana kupfuura. December 12, 2011: FDA inoramba Chikumbiro cheCitizen zvakare , ichiita kuti nyaya yeTummino v. Hamburg izaridzwe zvakare musi waFebruary 8, 2012.
Saka, mugore ra2012 rinotanga nemhosva iyi yepamatare apo avo vanopomerwa vanyorera chirevo chekutanga kubvumirwa izvo zvingabvumira kuwanikwa kweTTC kwevamwe vese vevabereki vanorwisa mishonga yevhisi yepamusoro (iyo imwe chete uye maviri mapurogiramu) pasina makore kana kuti zvikamu zvekutengeswa kwekutengesa. .. ..
- February 16, 2012: Mutongi Korman anorondedzera "Kuratidzira Kuratidza Chikonzero" achida kuziva "nei FDA isingafaniri kutungamirirwa kuti iite Plan B inowanikwa kune avo vanhu avo zvidzidzo zvakapihwa kuRWD kuratidzira vanogona kunzwisisa kana kushandiswa kwe Purogiramu B yakakodzera uye mirayiridzo yekushandiswa kwayo. "
- March 9, 2012: Teva mafaira kushandiswa kwakagadziriswa kuita chirongwa B Chimwe Chetatu chiripo pasina mutemo kune vatengi vane makore gumi nemashanu uye kupfuura uye kuti zvibvumire kuti zviwanikwe muchikamu chekuronga mhuri chemishonga (pamwechete nemakondomu , Today Today , spermicide , makondomu emadzimai , uye mafuta ) panzvimbo pekumeri kwekambani yemishonga, asi uchapupu hwezera hunenge huchiri kudiwa panguva yekuvhara.
- Nyamavhuvhu 12, 2012: FDA inobvumira kushandiswa kwekukurumidza kwekudzivirira kubata pamuviri weEvery Choice One Dose , imwe piritsi imwechete yakafanana neChirongwa B Chimwe Chete, uye inopa OTC / mushure mamiriro ekutengesa kwemapurisa kune avo vane makore 17 kana kupfuura vasina mushonga.
Uye neizvi, ndinokutungamirira mugore ra2013, uye kuguma kwenhau yekukurumidza kubata pamuviri, uye rwendo rwaro rurefu uye ruchikurumidza kuenda kune iko nhasi ...
- February 22, 2013: FDA inobvumira kushandiswa kwepabonde kweYay Way , imwe piritsi imwechete yakafanana neChirongwa B Rimwe-Chete, uye inopa OTC / mushure mamiriro ekutengesa kwemapurisa kune avo vane makore 17 kana kupfuura vasina mushonga.
- Musi waApril 5, 2013: Mutongi weDunhu reU.S. Edward R. Korman akadzosera chisarudzo cheDFA chokuramba Citizen Petition nemirairo yokuti iyo sangano ine mazuva makumi matatu ekubvumira kuwedzerwa kwekutengesa kwevevonorgestrel-based contraceptive emergency pasina kubviswa kwezera. Akatora zvisarudzo zveChinyorwa Sebelius se "sangano rezvematongerwe enyika, sasi zvisiri izvo, uye zvinopesana nesangano rinotangira." Mutongi Korman akazvidzawo FDA nekuda kwekuregererwa kwayo kusingafungidziki, achisimbisa kuti yakanga yava nemakore anopfuura 12 kubvira apo Citizen Petition yakaiswa.
- Musi waApril 30, 2013: Rimwe zuva kana maviri musangano wacho usati wadiwa kuti uite maererano neApril 5, 2013, mutemo wenheyo, FDA "inotendera" inobvumira kushandiswa kweTeva kushandurwa , zvichibvumira kutengeswa kweChirongwa B Chimwe Chimwe chepamusoro pashefu isina mishonga yevakadzi vane makore gumi nemashanu nevekare. Kunyatsochengetedza kuti kugamuchirwa kwekuita kweTeva "kwakasununguka pamhosva iyo" uye "chisarudzo chavo hachina kurongerwa kutonga mutongi." Zvakaitika kuti FDA yakapa chikumbiro cheTeva panguva ino? Hmm?
- May 1, 2013: Mazuva mashomanana asati aita FDA aifanira kutenderana nekutonga Mutongi Korman waApril 5, Dhipatimendi reUbhuku reUnited States rinokumbira uye rinokumbira kuti arambe achiraira, saka FDA haigoni kuwanikwa mukuzvidza dare.
- May 10, 2013: Mutongi Korman anoramba chikumbiro cheDENJ chekugara , achidaidza chiito ichi "frivolous" uye imwezve kuedza kweDAA kunonoka kugadzira chisarudzo.
- May 13, 2013: Dhipatimendi reRuramisiro rinokumbira kukwidza kwayo ne 2 US Circuit Court of Appeals muManhattan. Dare rinotambanudza musi wekupedzisira wekutonga kwevatongi Korman kusvikira musi waMay 28, 2013.
- Gumiguru 5, 2013: Mutongi wechitatu-arikumbira mutongi anoramba kubvumirwa kweDENJ kwekugara uye kurayira kusimudza zvigadziro zvezera rose uye kubvumira zvakakwana kune-in-counter status yemapiritsi maviri ekudzivirira kubata pamuviri, asi kwete kwepiritsi imwe yekukurumidza Kubata pamuviri - Kurongeka kweKorman kwepiriniti imwechete yekuvhara pamuviri nokukurumidza kwakambomirirwa kwenguva pfupi ichimirira chigumisiro chekuda kweDENJ.
- Gumiguru 10, 2013: IJOJ inoderedza kukwidza kwayo uye inobvumirana kutevera kusagadziriswa kwekutengesa OTC kweChirongwa B Chekutanga-Chero chero bedzi ma generic anoramba achiregererwa uye ari shure kwekambani. Ive FDA inobvunzawo Teva kuti ipe fomu yekuwedzera yekukumbira kubvunza pasina makore kana mitemo yekutengesa.
Drum roll ndapota ... mukana wehutano hwepabonde rekudzivirira pamuviri watakange tanga tichitungamirira kusvika - YES, iFUNGA pano .
- June 20, 2013: FDA inobvumira Purogiramu B Imwe-Nzira yepamusoro-kutengesa-kutengeswa kusina zvibvumirano zvezera. Dare racho rakapiwawo makore matatu chete eTeva kuti atengese Plan B One-Step OTC. Vagadziri ve 1-pill generic equivalents vanogona kutumira supplemental FDA mvumo yekutengesa-sales-sales mushure meTeva patent inopera muna April 2016.
- Gumiguru 25, 2014: Mukuedza kubvumira dambudziko reOTC reChoice One Dose uye My Way (maitiro anowanikwa 1-mapiritsi eChirongwa B Chimwe Chimwe), FDA inotumira tsamba kuvakadziri vemiti iyi inotaura kuti Chimbo cheTeva chokusarudzira "chinodzivirira" uye "chakanyanya." Iri sangano rinobvumira nzira idzi dzekushandisa dzingatengeswa pasina chikwata chekutengesa kana kuti zvipingamupinyi zvemashure pasi pemamiriro ekuti vatengi vanoratidzira pane zvinyorwa zvinoratidza kuti kushandiswa kwezvipembenene zvekuvhara kwekukurumidza kunotarisirwa kune vakadzi vane makore gumi nemashanu kana kupfuura. Kubatanidzwa kweizvi zvinoshandiswa pamushandisi unotsigira teva yekutengeserana kwekutengeserana pamwe chete nekubvumira dzimwe nzira dzekugadzira dzingatengeswa pamusoro pe-counter, pasina mvumo kana yezera rinoda.
Nhoroondo yekudzivirira kwepabonde inosanganisa inobatanidza kukunda kukuru uye kumwe kukunda. Pakuguma, kuwanikwa kwekudzivirira uku kwakakosha kunoshanda sechimwe chinhu chekudzivirira kusununguka zvisina kurongwa uye kubvisa pamuviri.
Sources:
Dhipatimendi reHutano neHuman Services. "Zvigadzirwa zvemishonga yepiritsi; Zvimwe zvakabatanidza mishonga yekudzivirira mishonga kuti ishandiswe sepascoital inobata pamuviri "; Cherechedza. Federal Register . February 25, 1997; vol 62: kwete 37: 8610-8612. Yakasvika 10/11/12.
DG Weismiller. "Emergency Contraception." American Family Physician . 2004 Aug 15; Vol. 70 (4): 707-714. Yakasvika 10/11/12.
FDA Newsroom. [Gumiguru 26, 2005]. "FDA Inotora Chigadziriswa Purogiramu B." Nyaya yaKomisheni weDared Lester M. Crawford. Yakasvika 10/11/12.
FDA Newsroom. [April 30, 2013]. "FDA inobvuma chirongwa B Chimwe chiito chekubata pamuviri nokukurumidza pasina mushonga wevakadzi vane makore gumi nemashanu kana kupfuura." Yakasvika 10/11/12.
J. Trussell, F. Stewart, F. Guest, uye RA Hatcher. "Emergency Contraceptive Pills: Chimwe Chinhu Chinyoresa Kuita Kuderedza Kusarudzwa Kwisina Kuda." Kuronga Kwemhuri Mafungiro . 1992; 24: 269-273. Inowanikwa kuburikidza nehurumende yekunyoresa.
PFA Van Tarisa na H. von Hertzen. "Emergency Contraception." British Medical Bulletin . 1993; 49: 158-170. Inowanikwa kuburikidza nehurumende yekunyoresa.
P. Murray. [September 9, 2005]. "Clinton, Murray uye 11 Senators Vanokumbira GAO kubudisa Kuongorora kweChirongwa B Kugonesa Nzira." Yakasvika 10/11/12.
RL Mackenzie. [Svondo 2, 1998]. "Preven Emergency Contraceptive Kit - The First and Only Emergency Contraceptive Product - Yakagamuchirwa neRDA." Yakasvika 10/11/12.
Tummino v. Hamburg (Nha. 12-CV-763) Nyaya: 13-1690 (US Court of Appeals for Second Circuit June 5, 2013). Yakasvika 6/6/13.
Tummino v. Hamburg , No. 12-CV-763 (ERK) (VVP) (EDNY Kubvumbi 4, 2013). Yakasvika 10/11/13.
Tummino v. Torti , 603 F. Supp. 2d 519 (EDNY, Mar. 23, 2009). Yakasvika 10/11/13.