Ku United States, mbiri yokhudza kulera kwadzidzidzi kwachititsa kuti pakhale mikangano , yanyalanyaza zokambirana za ndale ndipo inachititsa milandu. Chikhalidwe chowopsa cha kubereka mwadzidzidzi chimachokera, makamaka, ngati anthu amakhulupirira kuti mapiritsi am'mawa amatha kuteteza mimba kuti isachitike kapena ngati imathetsa mimba yomwe yakhazikitsidwa kale.
Sungani B Phunziro Loyamba (mwachitsanzo, mapiritsi amatha-mmawa) nthawi zambiri amasokonezeka ndi RU486 (mwachitsanzo, piritsi lochotsa mimba). Mankhwala awiriwa si ofanana ndipo amagwiranso ntchito mosiyana pa nthawi yobereka.
Ziribe kanthu zomwe zikhulupiliro zanu ziri, mbiri ya kulera kofulumira komanso kuvomerezedwa kwa FDA ku US wakhala ulendo wosavuta kwambiri. Mizu ya masiku ano yobereka mofulumira ikhoza kuyambira kumaphunziro a zinyama m'ma 1920, komabe kugwiritsa ntchito kwa anthu kunayamba m'ma 1960. Tsono phokoso, izi zingakhale zovuta ...
Mndandanda: Mbiri ya Kulera Kwadzidzidzi
- Chakumapeto kwa zaka za m'ma 1960: Kulera kwadzidzidzi kunagwiritsidwa ntchito ngati chithandizo cha operekera chiwerewere kuti asatenge mimba yosakonzekera . Madokotala angapereke mlingo waukulu wa estrogen atagwiriridwa. Ngakhale kuti izi zinkapezeka zogwira mtima, palinso zowawa zambiri.
- Kumayambiriro kwa zaka za m'ma 1970: Njira ya Yuzpe inayambitsidwa, yomwe idaphatikizidwa ndi mahomoni ophatikizapo ma ARV ndipo m'malo mwake anagwiritsa ntchito njira zapamwamba zowonongeka za mimba za m'ma 1960.
- Chakumayambiriro kwa m'ma 1970: Madokotala anayamba kupereka chingwe chamkuwa monga njira yokha yosavomerezera kubereka.
Kupita Mofulumira Patapita zaka makumi awiri ...
- February 25, 1997: Pokhala ndi cholinga cholimbikitsa olimbikitsa kupanga chithandizo chodziletsa, apolisi a FDA adatumizidwa ku Federal Register yomwe Commissioner ali nayo, "adatsimikiza kuti zina zothandizira kulandira mankhwala ndi ethinyl estradiol ndi norgestrel kapena levonorgestrel zili zotetezeka komanso zogwiritsidwa ntchito monga kulandira chithandizo cham'tsogolo mwadzidzidzi " komanso kuti FDA ikupempha " kugonjera mapulogalamu atsopano ogwiritsira ntchito mankhwalawa. "
Bungweli linanenanso kuti likugwirizana ndi Komiti Yowonongeka ya FDA ya June 28, 1996, yomwe inagwirizana kuti kugwiritsa ntchito magulu anayi a mahomoni kungagwiritsidwe ntchito mosamala ngati chithandizo chodziwitsira kubereka - kupereka chivomerezo cha "off-label" mapiritsi oletsa kubereka omwe ali ndi00 mg ya ethinyl estradiol ndi 50 mg ya norgestrel (2 mapiritsi tsopano / mapiritsi 2 m'masiku 12); .03 mg ya ethinyl estradiol ndi 30.30 mg ya norgestrel (4 mapiritsi tsopano / 4 mu maola 12) ;. 03 mg ya ethinyl estradiol ndi.15 ya levonorgestrel (mapiritsi 4 tsopano / 4 mwa maola 12); ndi .03 mg ya ethinyl estradiol ndi .125 mg ya levonorgestrel (mapiritsi 4 tsopano / 4 mu maola 12). Panthawi imeneyo, a FDA anapereka malangizo a momwe mapiritsi otsatirawa angagwiritsire ntchito ngati njira zowulera zovuta: Ovral, Lo / Ovral, Nordette, Levlen, Triphasil, ndi Tri Leven.
Komabe, a FDA adanenanso, mu Federal Register statement, kuti akukana pempho la November 1994 anthu akufunsa bungwe kuti alole ogulitsa ena kuphatikizapo mapiritsi oletsa kubereka kusintha zolemba zawo kuphatikizapo momwe angagwiritsire ntchito mapiritsi monga chithandizo chadzidzidzi .
- September 2, 1998: Cholinga cha Preven Emergency Contraception Kit chinakhala chinthu choyamba chovomerezeka ndi FDA makamaka pa chithandizo chodziletsa. Poyang'aniridwa ndi dongosolo la Yuzpe, Chidziwitso Chodziwitsira Chodziwika Chotsatira Choyambitsa Mimba chimakhala ndi mayeso okhudzana ndi kutenga mimba, sitepe yotsatira ndi "Patient Information Book" ndi mapiritsi anayi (omwe ali ndi 0.25 mg ya levonorgestrel ndi 0.05 mg ya ethinyl estradiol) - 2 kuti akhale amatengedwa mwamsanga ndipo 2 kuti atenge maola 12 pambuyo pake. {* Zindikirani: chida ichi sichipezeka.}
- July 28, 1999: The FDA inavomereza Plan B ngati njira yoyamba progesin yokha yofulumira kubereka yomwe ikupezeka ku US.
- February 14, 2001: Mzinda wa Zolinga za Uchembere unalembetsa Pempho Loyamba ndi FDA m'malo mwa mabungwe ochipatala ndi oposa 70 kupanga Mapulani a B.
- April 21, 2003: Barr Laboratories (amene amapanga Plan B) amavomereza ntchito ndi FDA kuti asinthe Mapulani a B kuti asalembedwe.
- December 2003: Kugwiritsa ntchito ndi deta kuchokera ku maphunziro oposa 40 zinayambitsidwa ndi komiti ziwiri zothandizira a FDA, komiti ya Reproductive Health Drugs komiti ya Nonprescription Drugs, omwe onse adagwirizana kuti Plan B inali yotetezeka komanso yogwira ntchito. Mbendera ya FDA imavomereza 23-4 kuti apange dongosolo la B kuti ligulitsidwe pa-counter. Ogwira ntchito a FDA, kuphatikizapo John Jenkins, mkulu wa FDA's Office of New Drugs, adagwirizananso ndi ndondomekozo.
Pafupifupi 6 Miyezi Patapita ...
- May 2004: A FDA adapereka kalata yopita kwa Barr Laboratories, potsutsa zopempha za OTC za kampaniyo ndipo akunena za nkhawa za achinyamata ndi khalidwe la kugonana. Chisankho ichi chinapangidwa mosasamala za maphunziro omwe amasonyeza ntchito ya Plan B sanawonjezere chiwerewere kapena kusintha momwe amayi amagwiritsira ntchito njira zina zoletsa kubereka . Kusunthika kwa FDA kusanyalanyaza deta za sayansi ndi maganizo a akatswiri anawotcha moto kuchokera ku sayansi. A American College of Obstetricians and Gynecologists adanena kuti chisankho "chodetsa makhalidwe" ndi "banga lamdima pa mbiri ya bungwe lozikidwa ndi umboni monga FDA."
- June 15, 2004: Asenatenti Patty Murray ndi Hillary Clinton akupempha kuti General Accountability Office (GAO) ayambe kufufuza mu FDA a May 2004 kukana ntchito ya Barr Laboratories kuti apange Mapulani B popanda mapulani.
- July 2004: Barr Laboratories inapereka ntchito yowonjezera mogwirizana ndi zomwe a FDA analangiza kuti apeze okha OTC omwe ali ndi zaka zapakati pa 16 ndi zapakati. Ndondomeko za FDA zogwirizana ndi January.
- August 2004: Nkhani yowonongeka mwachangu m'magaziniyi, American Family Physician inafotokoza kuti "FDA yamasula njira 13 zothandizira kulandira chithandizo kuti zikhale zotetezeka komanso zogwiritsira ntchito pogwiritsa ntchito njira zoberekera zachangu" ndipo adawonjezera Alesse, Levlite, Levora, Trivora, Ogestrel, Low Ogestrel, ndi Ovrette kupita kumayambiriro a February 1997 FDA mndandanda wamapiritsi omwe angagwiritsidwe ntchito ngati mankhwala osokoneza bongo.
Plot Amatha mu 2005 ...
- January 2005: The FDA sanasankhepo pa Barr Laboratories. Potsalira chisankho, Asenatenti Patty Murray, ndi Hillary Clinton adagwira ntchito ya Lester Crawford kuti akhale a FDA Commissioner. Chigawo cha Ufulu Wobadwira chimaperekanso mlandu wotsutsana ndi FDA kuti silingakwanitse kukwaniritsa nthawi yake ya Januwale ndi kunyalanyaza sayansi ndi kukonza mapulani a B ndi zosiyana ndi mankhwala ena.
- July 2005: A Senatenti Clinton ndi Murray akugwira ntchito pa Crawford (yemwe adatsimikiziridwa ndi Senate) Pulezidenti wa Health and Human Services, Michael Leavitt, adawalonjeza kuti FDA idzasankha pa September 1, 2005.
- August 26, 2005: Mmalo molengeza chisankho pazowonjezeredwa, a FDA adatsutsa chigamulocho, mosakayikira, kuti alowetse anthu. Commissioner Crawford adavomereza kuti "chidziwitso cha sayansi chiripo chokwanira kuthandizira kugwiritsa ntchito bwino mapulani a B B monga chogulitsa," koma FDA idakalilola kulola kuti OTC ipeze, mmalo mwake kusankha kubwezera chigamulo kachiwiri. Crawford adanena kuti bungweli silikanatha kugamula chisankho chovomerezeka potsatira pempholi mpaka " zisankho zosatsutsika ndi ndondomeko za malamulo" zikhoza kupitsidwanso. Ngakhale kuti bungwe la akatswiri la FDA linavomerezedwa ndi OTC pa Mapulani a B pa 23 mpaka 4 voti, Crawford adasankha kupondereza gulu lake ndikusunga Plan B ngati mankhwala osokoneza bongo.
- September 1, 2005: Wothandizira FDA Commissioner for Women's Health, Dr. Susan Wood adadzipereka potsutsa chigamulo cha Crawford chochedwa kuchepetsa kupanga chisankho. Dr. Wood adanena kuti "ogwira ntchito za sayansi [pa FDA] anatsekedwa pa chisankho ichi" ndipo kulengeza kwa Crawford, "kunasokonezeka kwambiri pakupanga kupanga chisankho." Pomwe anafunsa mafunso, Dr. Woods anafotokoza kuti ndi angati anzakewo "akuda nkhawa kwambiri ndi malangizo a bungwe," ndipo mwa imelo kwa azimayi ogwira nawo ntchito a FDA ndi ogwira ntchito, akuvomereza kuti achotsa ntchito ponena kuti, "sangathenso kukhala antchito ngati umboni wa sayansi ndi zachipatala, wofufuzidwa bwino kuti avomerezedwe ndi akatswiri ogwira ntchito pano, wasokonezedwa. "
- September 9, 2005: Asenatere Murray ndi Clinton, omwe tsopano akugwirizana ndi anzawo 11 ku Senate ya United States, adaitanitsa United States GOA kuti amvetsetse zomwe adafufuza pofufuza za FDA kukana mapulani a Plan B. M'kalata yawo yopita ku GAO, a Senators akudandaula kuti zakhala zaka zoposa ziwiri, ndipo FDA ikupitirizabe kuchepetsa chisankho cha Plan B. Izi zikudetsa nkhawa chifukwa mabungwe akuluakulu azachipatala oposa 70 akuthandizira kugwiritsa ntchito Mapulani a BT, mapulogalamu a sayansi omwe alipo omwe angapezeke kuti ntchito ya Plan B ikhale yotchuka, ndipo komiti ya uphungu wa sayansi ya FDA inavomereza kwambiri OTC omwe alipo. Asenere akulemba kuti, "Kusintha kwa zochitikazi kumabweretsa chidwi chokhudza ndale kwakhala kudetsa nkhaŵa za thanzi labwino pamtundu uwu."
- September 24, 2005: Patatha miyezi iwiri yokha, Commissioner Crawford akusiya ntchito.
- Okthoba 2005: Dr. Frank Davidoff, yemwe kale anali membala wa Komiti Yoperekera Mankhwala Osokoneza Bongo, nayenso anadzipatulira. New England Journal of Medicine inalembetsa nkhani yake yachiŵiri, kuimbidwa mlandu wa FDA ndi "kuseketsa njira yofufuza umboni wa sayansi." GAO imatchula kuti chipani cha FDA "chadabwitsa kwambiri," chimapangitsa Sen. Clinton kuti afotokoze kuti lipotili "likuwoneka kuti limatsimikizira zomwe takhala tikuziganizira kwa nthawi ndithu: Sayansi inasokonezeka pa chisankho cha FDA pa dongosolo B."
Whew ... 2005 inali yovuta kwambiri m'mbiri ya vuto lachangu. Kodi chaka cha 2006 chasungiranji mapiritsi am'mawa?
2006 mpaka 2013
- March 2006: Andrew von Eschenbach, bwenzi ndi dokotala wakale wa George W. Bush, adaponyedwa kuti alowe m'malo mwa Crawford ndipo amasankhidwa kuti akhale Acting Commissioner. Pansi pa udindo wake, adafalitsa pepala lolakwika loletsa kuchotsa mimba ndi khansa ya m'mawere. A Senema Clinton ndi Murray akutsutsa Von Eschenbach kutsimikizira kuti a FDA alamula pulogalamu ya Plan B.
- June 9, 2006: A FDA amakana Citizen Petition 2001.
- July 2006: The FDA imati malamulo atsopano sakufunika, ndipo tsiku lake asanavomereze, atachita FDA Commissioner Andrew von Eschenbach poyera apempha Barr Labs kusintha ndi kubwezeretsa ntchito yake mwa kusintha zaka OTC zaka Plan Plan 18 mpaka zaka .
- August 24, 2006: A FDA adalengeza kuti akugwirizana ndi malonda a Plan B OTC kwa zaka 18 ndi zapakati pomwe ana a zaka khumi ndi zisanu ndi anayi (18) angapitirizebe mankhwalawa kuti apeze njira yopezeramo njira zoberekera.
- November 2006: Barr anayamba kutumiza mapepala opanda mapepala a Plan B ku pharmacies kudutsa US.
Kupita Patsogolo Kwazaka 2 ...
- December 23, 2008: Teva Pharmaceutical Industries imalengeza kuti akupeza Barr. Pulani B tsopano ikugulitsidwa ndi Duramed Pharmaceuticals, yomwe imathandizidwa ndi Teva.
Ndipo Saga Amatsitsidwanso Patatha 3 Patapita ...
- March 23, 2009: Mu Tummino v. Torti , Edward Korman wa Federal Court adalamula FDA kuti alolere ana a zaka 17 kugula Plan B OTC pansi pa zofanana zomwe zinalipo kale kwa amayi ndi zaka 18. Otsutsa pa mlanduwu adakayikira kuti FDA inakana Chigwirizano cha Nzika ya 2001 chinali "yosasamala komanso yopanda nzeru chifukwa sizinali zotsatira za kupanga maganizo ndi bungwe labwino la bungwe la chikhulupiriro." Woweruza Korman anavomera ndipo ananena kuti maganizo a FDA alibe chikhulupiriro ndipo bungweli likuika ndale patsogolo pa thanzi la amayi. Adafunsanso FDA kuti ayang'anenso za kukana kwake Citizen Petition.
- April 22, 2009: Chifukwa cha fuko la federal limalangiza a FDA kuti alolere zaka 17 kuti agule Plan B, a FDA amatsutsa aliyense powauza kuti a zaka 17 angathe kugula Plan B OTC. Koma, chidziwitso chonse ichi chinalidi kuti FDA ikulengeza kuti yadziwitsa wopanga Plan B kuti kampaniyo, podzipereka ndi kuvomereza ntchito yoyenera , malonda a B B popanda chilolezo kwa akazi a zaka zapakati pa 17 ndi kupitirira. Chilengezo ichi chimayambitsa kubereka kwadzidzidzi kupeza njira yobwereranso kumaso.
- June 24, 2009: A FDA amavomereza ntchito yokhayokha ya Next Choice , mapulani a Plan B.
- July 13, 2009: The FDA adalengeza kuvomerezedwa kwa Plan B One-Step (piritsi imodzi yokha ndi mapulani a Plan B). Panthawiyi, a FDA aperekanso mwayi wa OTC, kulola amayi ndi abambo azaka 17 kapena kupitapo kuti agule Mapulani a B B Yoyamba pamsika wa mankhwala osakhala ndi chidziwitso cha zaka (omwe ali ndi zaka 17 amafunikira mankhwala).
- August 28, 2009 : A FDA amavomereza kugulitsa kwa OTC ya Next Choice, mapulani a Plan B, kwa onse a zaka 17 kapena kuposerapo (atsikana 16 ndi achinyamata amafunikira mankhwala kuti apeze Chotsatira Chotsatira).
- September 2009: Ndondomeko B Yotsimikizika B idayamba kupezeka pamasitolo am'madera ogulitsa m'mayiko onse, ndikupanga mapulaneti akale a Mapulani B.
2009 inkawoneka ngati chaka chachikulu mu mbiri yachangu. Tiyeni tipite patsogolo patatha chaka chimodzi ...
- August 16, 2010: The FDA imapereka chithandizo chomaliza kwa kulera kwadzidzidzi, Ella . Ella amapezeka kokha ndi mankhwala ndipo adapezeka pamasitomala ozungulira madera a December 2010. Amagwira ntchito mosiyana ndi Plan B One Step.
Tsopano, Konzekerani 2011 (Akuwombera Ignite, Apanso) ...
- February 7, 2011: Teva Pharmaceuticals inapereka ntchito yatsopano ya mankhwala osokoneza bongo ndi FDA yopempha kuti Pulogalamu Yoyamba B igulidwe pa-counter, popanda malire a zaka (kuphatikizapo deta yowonjezera yosonyeza chitetezo chake kwa zaka zonse).
- December 7, 2011: The FDA inaganiza kupereka pempho Teva Pharmaceutical kukweza zaka zonse zoletsedwa ndikulola Mpangidwe B Bwalo limodzi kugulitsidwa pa-counter, popanda mankhwala. Komabe , pasadakhalepo kale, Dipatimenti ya Zaumoyo ndi Zaumunthu Mlembi Kathleen Sebelius akuyang'anira chigamulo cha FDA ndikulamula bungwe kuti litsutse pempho la Teva. Sebelius amatchula deta yosakwanira yothandizira kulola Pulogalamu Yoyamba B kuti igulidwe pamsika kwa atsikana onse a msinkhu wobereka. Anafotokozanso kuti atsikana omwe ali ndi zaka 11 amatha kukhala ndi ana ndipo samaganiza kuti Teva anatsimikizira kuti atsikana ang'onoang'ono amatha kumvetsa momwe angagwiritsire ntchito mankhwalawa popanda kutsogoleredwa ndi anthu akuluakulu. Chisankho ichi chinatsimikizira zomwe zikufunikira kuti Pulani B Yoyamba (kuphatikizapo Next Choice) iyenerabe kugulitsidwa kuseri kwa zipangizo za pharmacy pomwe wamasitolo amatha kutsimikizira kuti wogula ali ndi zaka 17 kapena kuposa. December 12, 2011: The FDA amakana Citizen Petition kachiwiri , kuchititsa kuti Tummino v. Hamburg atsegulidwe pa February 8, 2012.
Choncho, chaka cha 2012 chimayamba ndi khoti lino pomwe oimbawo amapereka chilolezo choletsedwa choyamba chomwe chingawathandize kuti OTC ipeze njira zonse zopezera kulandira chithandizo chadzidzidzi (tsamba limodzi limodzi ndi awiri mapiritsi) opanda zaka kapena zolepheretsa kugulitsa. .. ..
- February 16, 2012: Woweruza Korman akufotokozera "Cholinga Chowonetsera Chifukwa" pofuna kudziwa "chifukwa chake FDA sichiyenera kupangidwira kupanga B B kwa anthu omwe maphunzirowa akuyendera ku FDA akuwonetsa ngati ntchito Pulani B ndi yoyenera komanso malangizo omwe angagwiritsidwe ntchito. "
- March 9, 2012: Fayizani maofesi omwe mukukonzekera kuti mupange Mapulani a B B Yokhawokha popanda mankhwala kwa anthu ogwira ntchito zaka 15 kapena kupitirira komanso kuti mukhale nawo mu gawo la kulera la mankhwala (pamodzi ndi makondomu , Today Sponge , spermicide , kondomu za akazi , ndi mafuta ) osati kumbuyo kwa mankhwala, koma umboni wa ukalamba udzafunikanso pakapita.
- July 12, 2012: A FDA amavomereza kugwiritsa ntchito njira ya Next Choice One Pose , pulogalamu imodzi yofanana ndi Plan B One Step, ndipo amapereka OTC / kumbuyo kwa mankhwala omwe ali ndi zaka 17 kapena kuposera popanda mankhwala.
Ndipo ndi izi, ndikukutsogolerani mu chaka cha 2013, ndikumapeto kwa mbiri ya kulera kofulumira, ndi ulendo wake wautali komanso wovuta kuti ufike komwe kuli lero ...
- February 22, 2013: A FDA amavomereza kugwiritsa ntchito njira yowalera njira ya My Way , piritsi limodzi lofanana ndi Plan B One-Step, ndipo amapereka OTC / kumbuyo kwa mankhwala omwe ali ndi zaka 17 kapena kuposera popanda mankhwala.
- April 5, 2013: Woweruza Wachigawo ku United States Edward R. Korman adasintha chisankho cha FDA chokana Citizen Petition ndikulamula kuti bungweli likhale ndi masiku makumi atatu kuti lilole kugulitsa kwa malonda a levonorgestrel omwe ali okhudzidwa ndi mavuto otha msanga. Anadziwika ndi zisankho za Mlembi Sebelius monga "zokhudzana ndi ndale, zosagwirizana ndi sayansi, komanso zosiyana ndi zomwe zinachitika kale." Woweruza Korman adakalipira a FDA chifukwa cha kuchedwa kwake kosayembekezereka, akugogomezera kuti adakhalapo zaka 12 kuchokera pamene Citizen Petition inalembedwa.
- April 30, 2013: Tsiku limodzi kapena awiri isanachitike kuti bungweli liyenela kutsatila pa April 5, 2013, chigamulo cha khoti, FDA "yabwino" imavomereza ntchito ya Teva yokonzedwanso , kulola kugulitsa Plan B One step pa alumali popanda mankhwala kwa amayi a zaka 15 ndi akulu. Kuonetsetsa kuti chivomerezo cha Teva ndizo "popanda chigamulo" ndipo "chisankho chawo sichiyenera kukwaniritsa chiweruzo cha woweruzayo." Mwadzidzidzi kuti FDA inapereka pempho la Teva panthawiyi? Hmm?
- May 1, 2013: Masiku angapo kuti a FDA asagwirizane ndi chigamulo cha Korman cha April 5, Dipatimenti Yachilungamo ya ku United States ikupempha kuti apitirize kulamula, choncho a FDA sangapezeke kuti akunyalanyaza milandu.
- May 10, 2013: Woweruza Korman akukana pempho la DOJ kuti apitirize , akuyitanitsa kuti " akuchita mantha " komanso mayesero ena a FDA kuchepetsa kupanga chisankho.
- May 13, 2013: Dipatimenti Yowona Chilungamo ikudandaula ndi Khoti Lalikulu la Malamulo la 2 ku United States ku Manhattan. Khotilo likudutsa nthawi yomaliza ya Oweruza Korman mpaka May 28, 2013.
- June 5, 2013: Woweruza milandu 3 adatsutsa pempho la DOJ kuti apitirize kukhala ndi malamulo oti athetsere zaka zonse zomwe zimaletsa zakale ndikulola kuti pulogalamu ya piritsi ikhale yodalirika, koma osati piritsi limodzi Kulandira chithandizo - Kulamula kwa Korman pa mapiritsi a pulogalamu yovomerezeka mwadzidzidzi kwaletsedwa kwa kanthawi potsatira zotsatira za pempho la DOJ.
- June 10, 2013: The DOJ akutsutsa pempho lake ndipo amavomereza kutsatira zogulitsa OTC za Plan B One Step malinga kuti generics amakhalabe zakale komanso kumbuyo. A FDA akufunsanso Teva kuti apereke pempho lopempha kuti asafunse zaka zotsalira kapena zogulitsa.
Galamukani chonde chonde ... mphindi ya mbiri yachangu yomwe takhala tikutsogolera - YESU, ndizomwe zili pano .
- June 20, 2013: A FDA amavomereza Mapulani A B Mmodzi Wachitatu pa malonda oposa omwe alibe malire. Bungweli linaperekanso mwayi wokhala ndi zaka zitatu za Teva kuti agulitse mapulani a B B One-Step OTC. Opanga mapiritsi a 1 ophatikizapo mavitamini angapereke mafomu owonjezera a FDA a malonda owonjezera pamtunda pambuyo pa chivomezi cha Teva mu April 2016.
- February 25, 2014: Pofuna kulola kuti OTC Ikhale ndi Chotsatira Chokha ndi Njira Yanga (njira zowonjezera zapiritsi 1 zopanga mapulani a B B), FDA imatumiza kalata kwa opanga mankhwalawa kuti Cholinga cha Teva chokhalira "chokhazikika" ndi "chokwanira kwambiri." Dipatimentiyi imavomereza njira zowonjezera izi kuti zigulitsidwe popanda kugulitsidwa kapena zoletsedwa zakale pokhapokha ngati opanga akuwonetsera pa chigulangachi cha mankhwala kuti kugwiritsa ntchito njira zoperekera zachangu kwa amayi a zaka zapakati pa 17 ndi kupitirira. Kuphatikizidwa kwa izi zomwe zinagwiritsidwa ntchito pa phukusili kumagwirizanitsa ntchito ya Teva yokhayokhayo komanso ikulolera njira zina zowonjezera kuti zigulitsidwe pa-counter, popanda zofunikira za mankhwala kapena zaka.
Mbiri ya kulera mofulumira imaphatikizapo kupambana kwakukulu ndi kugonjetsedwa kwina. Pamapeto pake, kupezeka kwa chithandizo chofunikira chimenechi ndi chinthu chimodzi chokha popewera mimba yosakonzekera ndi mimba.
Zotsatira:
Dipatimenti ya zaumoyo ndi zithandizo zaumunthu. "Zida zamagwiritsidwe ntchito mankhwala; Zina zimagwirizanitsa njira zothandizira kulera pakamwa kuti zigwiritsidwe ntchito monga chithandizo cholera chithandizo cham'tsogolo msanga "; Zindikirani. Federal Register . February 25, 1997; vol 62: no 37: 8610-8612. Inapezeka pa 10/11/12.
DG Weismiller. "Kulera Kwadzidzidzi." American Family Physician . 2004 Aug 15; Vol. 70 (4): 707-714. Inapezeka pa 10/11/12.
Chipinda cha FDA. [August 26, 2005]. "FDA ikugwira ntchito pa ndondomeko B." Mawu a Commissioner wa FDA Lester M. Crawford. Inapezeka pa 10/11/12.
Chipinda cha FDA. [April 30, 2013]. "FDA imavomereza Plan B imodzi Yoyamba yachangu yobereka popanda kulandira mankhwala kwa akazi a zaka 15 kapena kuposerapo." Anapezeka pa 10/11/12.
J. Trussell, F. Stewart, F. Guest, ndi RA Hatcher. "Mapiritsi Odziletsa Odzidzimutsa: Zomwe Zingatheke Kuchepetsa Mimba Yosakonzekera." Kukonzekera za Kulera . 1992; 24: 269-273. Idapezeka kudzera mwachinsinsi.
PFA Van Look ndi H. von Hertzen. "Kulera Kwadzidzidzi." British Medical Bulletin . 1993; 49: 158-170. Idapezeka kudzera mwachinsinsi.
P. Murray. [September 9, 2005]. "Clinton, Murray ndi Asenati 11 Akupempha Gao kuti Zitulutse kafukufuku wa Mapulani a B Bvomerezedwa." Kufikira 10/11/12.
RL Mackenzie. [September 2, 1998]. "Kitengo Chokonza Mwadzidzidzi Choyambirira - Choyamba Chokhalitsa Chodziletsa - Chovomerezedwa ndi FDA." Kufikira 10/11/12.
Mlandu wa Tummino v. Hamburg (No. 12-CV-763) Mlanduwu: 13-1690 (Khoti la Malamulo la US ku Dipatimenti Yachiwiri ya June 5, 2013). Ipezeka 6/6/13.
Tummino v. Hamburg , No. 12-CV-763 (ERK) (VVP) (EDNY Apr. 4, 2013). Zapezeka 10/11/13.
Tummino v. Torti , 603 F. Supp. 2d 519 (EDNY, Mar. 23, 2009). Zapezeka 10/11/13.