EUnited States, imbali yokwaphulwa kwexesha eliphuthumayo kuye kwaphazamisa ingxabano , yaxotha iingxoxo zezopolitiko kwaye yavelisa izigwebo. Ingqumbo evuthayo yokukhulelwa ngokukhawuleza kubangelwa kukuba, nokuba abantu abakholelwa ukuba iipilisi zentsasa-ntsasa ziyakwenza ukuthintela ukuba ukhulelwe okanye kwenzeke ukuba kupheliswe ukukhulelwa okuseleyo.
Isicwangciso B Isinye Isinyathelo (oko kukuthi, iipilisi zasemva kwemva) zidla ngokudibanisa ne- RU486 (oko kukuthi, ipilisi yokukhupha isisu). Le miyeza emibini ayifani kwaye enye isebenza ngokuhlukileyo xa ifika kwinkqubo yokuvelisa.
Kungakhathaliseki ukuba zeziphi iinkolelo zakho, imbali yokuqhawula ngokukhawuleza kunye nokuvunywa kwayo kwe-FDA e-US kuye kwaba luhambo oluhambelanayo. Iingcambu zezokhuselo zengxamiseko zanamhlanje ziyakwazi ukulandelwa kwizifundo zezilwanyana kuma-1920, kodwa ukusetyenziswa kwabantu kwaqala ngawo-1960. Ngoko bhukle phezulu, oku kungaba luhambo olubi ...
Umda wexesha: Imbali yoKhuseleko oluPhezulu
- Maphakathi no-1960: Ukukhulelwa kwangokukhawuleza kwakusetyenziselwa unyango lwabalandeli bokudlwengula ukukhusela ukukhulelwa okungalindelekanga . Oogqirha babeza kwenza umthamo omkhulu we-estrogen emva kokudlwengulwa. Nangona oku kwafunyaniswa ukuba kuyasebenza, kwakukho nemiphumo emibi yecala.
- Ekuqaleni kwee- 1970: I-regimen ye-Yuzpe yaqaliswa, eyayiquka i- hormone formula kunye ne-do-stro-contraception method contraception methods ye-1960.
- Ngasekupheleni kwee-1970: Oogqirha baqala ukunikela nge- copper ye-IUD njengendlela yokuphela kokunakekelwa kwexesha elingxamisekileyo.
Ukukhawuleza Kwiminyaka Emibini ...
- NgoFebruwari 25, 1997: Ngenjongo yokukhuthaza abavelisi ukuba benze i-contraceptive eziphuthumayo zifumaneke, i-FDA ibhaliswe kwiRejista ye-Federal eyenziwa nguMkhomishinala, "yagqiba ukuba ezinye izixhobo zokukhulelwa zomlomo ezidibeneyo ezine- ethinyl estradiol kunye ne- norgestrel okanye i- levonorgestrel zikhuselekile kwaye zisebenza ngendlela ukukhulelwa kwexesha eliphuthumayo emva kokubambisana " kwaye ukuba i-FDA icela " ukungeniswa kwezicelo zamachiza ezintsha zokusebenzisa le nto. "
I-adjonge yongezelela ukuba iyavumelana neKomiti yeNgcebiso ye-FDA ka-Juni 28, 1996, eyagqiba ngokuqinisekileyo ukuba ukusetyenziswa kwemimiselo emine ye-hormone inokusetyenziswa ngokukhuselekileyo kwaye isebenzise ngokukhawuleza njengendlela yokukhulelwa ngokukhawuleza - ukunika imvume yayo "ye-label" yokusetyenziswa ngokukhawuleza kokukhusela iipilisi zokulawula izibelelo eziqulethe i -05 mg ye-ethinyl estradiol kunye ne -50 mg ye-norgestrel (2 iipilisi ngoku / iipilisi ezimbini kwiiyure eziyi-12); .03 mg ye-ethinyl estradiol kunye no -30 mg we-norgestrel (4 iipilisi ngoku / 4 kwiiyure eziyi-12);; 03 mg ye-ethinyl estradiol kunye ne -5 ye-levonorgestrel (iipilisi ezi-4 ngoku / 4 kwiiyure eziyi-12); kunye .03 mg ye-ethinyl estradiol kunye .125 mg ye-levonorgestrel (iipilisi ezi-4 ngoku / 4 kwieyure eziyi-12). Ngelo xesha, i-FDA yanikezela imiyalelo malunga neepilisi ezilandelayo zingasetyenziselwa ukukhusela iimeko eziphuculweyo: i-Ovral, Lo / Ovral, Nordette, Levlen, Triphasil, no-Tri-Levlen.
Nangona kunjalo, i-FDA iphinde iphawule, kwi- Register ye-Federal Register , ukuba iyayiphika isikhalazo sommila kaNovemba ka-1994 ecela i-agunya ukuba ivumele abenzi bezinto ezithile zokudibanisa iipilisi zokulawula ukuzala ukuguqula ukubhalisa kwabo ukufaka imiyalelo malunga nendlela yokusebenzisa loo mapilisi njengento yokukhusela ngokukhawuleza. .
- NgoSeptemba 2, 1998: I-Kit yokuLawulwa kokuPhepha okuKhuselekileyo yabaSebenzi bokuqala yoNyango yaba yi-FDA evunyelwe ngokukodwa ngokukhawuleza kokukhulelwa kokukhawuleza. I-modeled emva kwe-regimen ye-Yuzpe, i-Kit ye-Contraception Emergency Contraception Kit iqukethe uvavanyo lokukhulelwa kwamanzi, isinyathelo ngeyinyathelo "Incwadi Yolwazi Oluneziguli" kunye neepilisi ezine (nganye equkethe i-0.25 mg ye-levonorgestrel kunye ne-0.05 mg ye-ethinyl estradiol) - 2 kuthathwa ngokukhawuleza kunye no-2 kuthathwe iiyure ezili-12 kamva. {* Qaphela: le nto ayisayifumaneka.}
- NgoJulayi 28, 1999: ISicwangciso se-FDA esivunyiweyo se-B njengendlela yokuqala yeprogesin yokukhulelwa kwexesha eliphuthumayo etholakala e-US.
- NgoFebruwari 14, 2001: Isiko soLungelo lokuBala lufake isicelo soPhando lweSizwe kunye ne-FDA egameni lemibutho yempilo engama-70 kunye nempilo yoluntu ukwenza iSicwangciso B sifike kwi-counter-counter.
- Ngo-Ephreli 21, 2003: I- Barr Laboratories (ngoko umvelisi weCwangciso B) uhambisa isicelo kunye ne-FDA ukutshintsha iSicwangciso B kwi-odokotela ukuya kwisimo esingabhalwanga.
- NgoDisemba 2003: Isicelo kunye nedatha ezivela kwizifundo ezingaphezu kwe-40 zahlaziywa ngamakomiti amabini eengcebiso ze-FDA, ikomidi leZilwaphulozo zeMpilo kunye neKomiti engeyiyo yokuBhekiswa kwezidakamizwa, bonke abavumelene ngokuqinisekileyo ukuba iSicwangciso B sasiphephile kwaye sisebenze. I-panel ye-FDA ivoti 23-4 ukucebisa ukuba isiCwangciso B sithengiswe ngaphaya kwe-counter. Abasebenzi beengcali ze-FDA, kuquka uJohn Jenkins, intloko ye-ofisi ye-FDA ye-New Drugs, naye uyavumelana nesiphakamiso.
Malunga neenyanga ezintandathu ...
- NgoMeyi 2004: I-FDA ikhuphele incwadi eya kwiBar Laboratories, iphika isicelo se-OTC yokuthengisa kunye nenkcazo echaphazelekayo malunga nokuziphatha kwentsha kunye nokuziphatha ngokwesondo. Esi sigqibo senziwe naphezu kwezifundo ezibonisa ukusetyenziswa kweCwangciso B azange zandise ukuziphatha kakubi okanye zitshintshe ukusetyenziswa kwabasetyhini kwezinye iindlela zokulawula ukuzalwa . Le ntshukumo ye-FDA ukungaziboni iinkcukacha zesayensi kunye neengcamango zengcali zivutha umlilo kwizenzululwazi. I-American College of Obstetricians kunye neGynecologists ibize eso sigqibo "sokuziphatha kakubi" kunye "nebala elimnyama kwigama lenkampani ebonisa ubungqina njenge-FDA."
- NgoJuni 15, 2004: AmaSenenari uPatty Murray noHillary Clinton bacela ukuba i-Ofisi yoLwazi oluPhezulu lokuPhatha (GAO) iqalise ukuphicothwa kwi-FDA kaMeyi 2004 ukwenqatshelwa kwesicelo seBar Laboratories ukwenza iSicwangciso B sifumane ngaphandle komyalelo.
- NgoJulayi 2004: I- Barr Laboratories ithumele isicelo esihlaziyiweyo ngokuhambelana nesinconywa se-FDA sokufuna kuphela i-OTC imeko yabasetyhini abaneminyaka eli-16 nangaphezulu. Iishedyuli ze-FDA zesigqibo sokwenziwa ngoJanuwari.
- Ngo-Agasti 2004: Inkcazo yokuphonononga ngokukhawuleza kwinqaku, i- American Family Physician ichaza ukuba "i-FDA isuswe iifayile ezili-13 zomlomo wokukhulelwa komlomo ngokukhusela nokusebenza xa zisetyenziselwa ukukhulelwa ngokukhawuleza" kwaye zongeze iAlesse, Levlite, Levora, Trivora, Ogestrel, Low I-Ogestrel, kunye ne- Ovrette ukuya kwi-original ye-Febhuwari 1997 i-FDA uludwe lweepilisi ezingasetyenziselwa ukuba zisebenzise njenge-label-emergency labeling contraceptives.
I-Pllot Thickens ngo-2005 ...
- NgoJanuwari 2005: I-FDA ingazange isenze isigqibo kwi-Barr Laboratories ehlaziyiweyo yesicelo. Ukulindela isigqibo, iiSenators uPatty Murray, kunye noHillary Clinton babambelele ekutyunjweni kukaLester Crawford ukuba bakhonze njengomkomishinala we-FDA. Isiko soLungelo lokuBala kwakhona lufakela isigwebo malunga ne-FDA sokungaphumeleli ukuhlangabezana neemhla zokugqibela zeJanuwari kunye nokungayinaki isayensi kunye nokubamba iSicwangciso B kumgangatho ohlukile kunezinye iziyobisi.
- NgoJulayi 2005: USeninkulu uClinton noMurray baphakamise ukubamba kwabo kwiCrawford (emva koko uqinisekiswa yi-Senate) emva kokuba uNobhala wezeMpilo kunye neenkonzo zezoLuntu uMichael Leavitt uthembisa ukuba i-FDA iya kwenza isigqibo ngo-Septemba 1, 2005.
- Ngo-Agasti 26, 2005: Esikhundleni sokumemezela isigqibo kwisicelo esihlaziyiweyo, i-FDA ihlehlise isigqibo sayo ngokungapheliyo, ifuna ukuvumela uluntu. UMkomishinala uCrawford wavuma ukuba "ulwazi olukhoyo lwezesayensi lwanele ukuxhasa ukusetyenziswa okukhuselekileyo kweCwangciso B njengemveliso engaphezulu," kodwa i-FDA isahluleka ukuvumela ukufikelela kwe-OTC, kunokuba ukhethe ukuphinda uphinde wenze isigqibo kwakhona. UCrawford wathi i-arhente ayikwazanga ukufikelela kwisigqibo malunga nokuvunyelwa kwesicelo kuze kube yilapho "imiba engahambisani nokulawulwa kwemigaqo kunye nomgaqo-nkqubo" ingahlaziywa kwakhona. Nangona iphaneli yecandelo le-FDA liye lavuma isimo se-OTC yeSicwangciso B kwivoti engama-23 kuya kwe-4, uCrawford wakhetha ukongamela iphaneli yakhe kwaye ugcine iSicwangciso B njengesigqirha somthetho.
- NgoSeptemba 1, 2005: UMkomishinala we-FDA wezeMpilo yabasetyhini, uDkt. Susan Wood ushiye inqabana yesigqibo sikaCrawford sokulibaziseka ukwenza izigqibo kwakhona. UDkt. Wood uthi "abasebenzi bezenzululwazi [kwi-FDA] bavalelwe ngaphandle kwesi sigqibo" kwaye isaziso sikaCrawford, "saba ngumngcipheko ongekho mthethweni kwi-decision making making." Kwi-intanethi elandelayo, uDkt Woods uchaze ukuba bangaphi oogxa bakhe "baxhalabele kakhulu ngolu hlobo lwe-arhente," kunye ne-imeyile kubasebenzi be-FDA kunye nabasebenzi, ulungele ukuyeka kwakhe ngokuthi, "akakwazi ukukhonza njengabasebenzi xa ubungqina bezesayensi kunye nekliniki, bavavanywa ngokupheleleyo kwaye bacebisa ukuze kuvunywe ngabasebenzi bezengcali apha, sele ichithwe. "
- NgoSeptemba 9, 2005: AmaSenere uMurray noClinton, ngoku bajoyinwe no-11 wabo osebenza nabo kwi-Senate yase-United States, bacela i-United States i-GOA ukuba ikhulule iziphumo zophando lwayo ukuhlola ukukhishwa kwe-FDA yeSicwangciso B. Kwileta yabo eya kwi-GAO, ii-senator zibonisa ukuba zixhalabile ukuba sele zingaphaya kweminyaka emibini, kwaye i-FDA iyaqhubeka ilibazise isinqumo seSicwangciso B. Le nkxalabo iphakanyisiwe xa kunikezelwa ukuba imisebenzi engaphezu kwama-70 emikhulu yezokwelapha isekela ukusetyenziswa kwe-OTC yeSicwangciso B, inkxaso ekhoyo yolwazi olukhuselekileyo lokusetyenziswa kweCwangciso B njengemveliso ye-OTC, kunye nekomiti ye-advisory ye-FDA yevolontiya ivote kakhulu ngenxa yemveliso OTC. Ama-senators abhala athi, "Olu hlobo lweziganeko lushiya ingqiqo enzulu echaphazelekayo malunga nezopolitiko ziye zaphazamisa iinkxalabo malunga nempilo yoluntu kule nkqubo."
- NgoSeptemba 24, 2005: Emva kweenyanga ezimbini emva kokuqinisekiswa, uMkomishinala uCrawford uyasula.
- Oktobha 2005: UDkt. Frank Davidoff, owayengumalungu weKomiti yeNgcebiso ngeeDrakiti ezingekho phantsi kweNgxelo, naye wasula phantsi. I- New England Journal of Medicine ikhuphe i-editorial yayo yesibili, ihlawule i-FDA ngokwenza "ukunyeliswa kwenkqubo yokuvavanya ubungqina besayensi." I-GAO ibiza ukuphathwa kwe-FDA kwiplani B "engavamile," kucela uSen.Clinton ukuba abeke ingxelo yokuba ingxelo "ibonakala iyakuqinisekisa oko sikhankanywe khona ixesha elide: I-Science yatshatyalaliswa kwinkqubo yokwenza isigqibo se-FDA kwiCwangciso B."
I-Whew ... ngo-2005 yayinzima kakhulu kwimbali yokukhulelwa kwangxamisekileyo. Unyaka wango-2006 ugcina ntoni emva kwepilisi?
2006 ukuya ku-2013
- Matshi ka-2006: U- Andrew von Eschenbach, umhlobo kunye nodokotela owayesakuba nguGeorge W. Bush, uphethwe ukuba athathe indawo yeCrawford kwaye wamiselwa ukuba abe nguMkomishinala oLawulayo. Ngaphantsi kobunzima bakhe, wapapasha iphepha elichazwe ngokungahambi ngokukhipha isisu kunye nomhlaza wesifuba. AmaSenenkulu uClinton noMurray banqamle ukuqinisekiswa kweVon Eschenbach njengomkhomishina we-FDA elinde isinqumo seSicwangciso B.
- NgoJuni 9, 2006: I-FDA iphika isikhalazo seCitizen ye-2001 okokuqala ngqa.
- NgoJulayi 2006: I-FDA ithi imigaqo emitsha ayifuniyo, kwaye umhla ngaphambi kokuvalelwa kwakhe, u-Commissioner we-FDA u-Andrew von Eschenbach esidlangalaleni ucela iBarr Labs ukuba ahlaziye kwaye aphinde athumele isicelo sakhe ngokutshintshela umqobo we-OTC weCwangciso B ukuya kwi-18 ukuya phezulu .
- Ngo-Agasti 24, 2006: I-FDA ibhengeze imvume yayo yokuthengiswa kweCwangciso B OTC kulabo bantu abaneminyaka eli-18 ubudala nangaphezulu kanti abo babancinane kuneminyaka engama-18 babeya kufuna imirhumo ukuze bafumane le ndlela yokukhulelwa ngokukhawuleza.
- NgoNovemba 2006: UBarr waqala ukuthumela iiphakheji ezingabhalwanga kwiCwangciso B kuma-pharmacy ngaphesheya kwe-US.
Ukukhawuleza 2 iminyaka ...
- NgoDisemba 23, 2008: I- Teva Pharmaceutical Industries iyamemezela ukufumana iBarr. Isicwangciso B sithengiswa ngeDameded Pharmaceuticals, incediso yeTeva.
Kwaye i-Saga iyaphula kwakhona emva kweenyanga ezintathu ...
- Ngomhla wama-23 Matshi 2009: Kwi- Tummino v. Torti , iJaji leSigqeba se-Federal Court u-Edward Korman lalela i-FDA ukuba ivumele i-FDA ukuba inikwe i-Plan B OTC phantsi kweemeko eziye zafunyanwa kubafazi abaneminyaka eli-18 nangaphezulu. Abamangalelwa kulo mbandela baqinisekisa ukuba ukulahlwa kwe-FDA yeSicelo seSatifikethi se-2001 " kwakungabonakaliyo kwaye kungenangqiqo kuba kwakungekho umphumo wokuthatha isigqibo sokwenza isigqibo sokwenza isigqibo sobulungisa." IJaji uKorman yavuma kwaye yathi ingqiqo ye-FDA ayikho into ethembekileyo kwaye i-arhente ibeka ezopolitiko ngaphambi kokuba impilo yabasetyhini. Kwakhona wacela i-FDA ukuba iphinde iqwalasele kwakhona ukukhanyela kwayo isikhalazo seCitizen.
- Ngo-Apreli 22, 2009: Ngenxa yombutho wenkundla ye-federal eyala i-FDA ukuba ivumele ama-17 ubudala ukuba athenge iSicwangciso B, i-FDA idibanisa wonke umntu ngokumemezela ukuba abaneminyaka eyi-17 banokuthenga i-Plan B OTC. Kodwa, yonke le ntengiso iyenziwa ngokuqinisekileyo ukuba i-FDA imemezela ukuba ikwazisile umenzi weCwangciso B ukuba inkampani inokuthi, ngokungeniswa nokuvunyelwene nesicelo esifanelekileyo , iSicwangciso seMarhwebo B ngaphandle kwemvume kubasetyhini abaneminyaka eli-17 ubudala nangaphezulu. Esi simemezelo sibangela ukukhulelwa kwexesha eliphuthumayo ukufumana indlela yalo yokubuyela kwindawo ebonakalayo.
- NgoJuni 24, 2009: I-FDA iyavuma ukusetyenziswa kwemigomo kuphela ye- Next Choice , isiqulatho sesiqhelo sesiCwangciso B.
- NgoJulayi 13, 2009: I-FDA ibhengeze ukuvunyelwa kweCwangciso B inye-nyathelo (ipilisi enye ye-dose kunye nohlobo olutsha lweCwangciso B). Ngeli xesha, i-FDA iphinde ikhulise ngokusemthethweni ukufikelela kwe-OTC, ukuvumela abesifazana kunye namadoda aneminyaka eli-17 okanye ngaphezulu ukuba bathenge iSicwangciso B Isinye Isinyathelo kwinqanaba le-pharmacy ngaphandle kwemvume ekuqinisekiseni ubudala (abo bangaphantsi kwe-17 badinga imithi).
- Ngo-Agasti 28, 2009 : I-FDA iyavuma ukuthengiswa kwe-OTC ye-Next Choice, uhlobo lohlobo lwesiCwangciso B, kubo bonke abaneminyaka eli-17 okanye ngaphezulu (amantombazana angama-16 kunye nabancinci badinga umyalelo wokufumana i-Next Choice).
- NgoSeptemba 2009: Isicwangciso B Isinye-Isinyathelo siyafumaneka kwii-pharmacy zentengiso kwilizwe lonke, kwaye ukuveliswa kwexesha elidala lePlani B.
Ngo-2009 kubonakala ngathi unyaka omkhulu kwimbali yokukhulelwa kwengxaki. Masiqhubeke phambili malunga nonyaka omnye kamva ...
- Ngo-Agasti 16, 2010: I- FDA inika imvume yokugqibela kwenkqubo yokukhulelwa ngokukhawuleza, uElla . U-Ella ufunyanwa kuphela ngumyalelo wecawa kwaye wafumaneka kwi-shelf shelf ngeDisemba 2010. Usebenza ngokungafaniyo noCwangciso B Isinyathelo esinye.
Ngoku, Lungele u-2011 (Ubeka i-Ignite, kwakhona kwakhona) ...
- NgoFebruwari 7, 2011: I- Teva Pharmaceuticals ifake isicelo esitsha seziyobisi kunye ne-FDA icela ukuba isiCwangciso B esinye Isinyathelo sithengiswe ngaphaya kwe-counter, ngaphandle kwemingcele yeminyaka (kunye neenkcukacha ezongezelelweyo eziqinisekisa ukhuseleko lwalo lonke ixesha lokusebenzisa).
- NgoDisemba 7, 2011: I-FDA inqume ukunika isicelo seTe Pharmaceutical sokuphakamisa yonke imingcipheko yobudala kwaye ivumele iSicwangciso B Isinye Isinyathelo sokuthengiswa phezu kwe-counter, ngaphandle kwemvume. Nangona kunjalo , ekuhambeni okungazange kwenziwe ngaphambili, iSebe lezeMpilo kunye neNkonzo zoLuntu uNobhala uKeath Sebelius ulawula i-FDA imvume kwaye uyalela ukuba i-arhente iphikise isicelo seTeva. I-Sebelius icacisa idatha enganeleyo yokuxhasa ukuvumela iPlani B Iyinyathelo elilodwa ukuthengiswa ngaphezulu kwe-counter for all girls of age reproductive. Waphinde wachaza ukuba amantombazana abancinane abane-11 asemzimbeni onokukwazi ukuba nabantwana kwaye abazange bazive ukuba iTeva yabonisa ukuba intombazana encinane ingaqonda kakuhle indlela yokusebenzisa le mveliso ngaphandle kokukhokelwa kwabantu abadala. Esi sigqibo sagqiba iimfuno ezikhoyo ezi ziCwangciso B I-One Step (kunye neCandelo elilandelayo) kufuneka zithengiswe emva kokubala kwee-pharmacy emva kokuba i-pharmist inokuqinisekisa ukuba umthengi uneminyaka eli-17 okanye ngaphezulu. NgoDisemba 12, 2011: I-FDA iphika i-Petition Citizen, kwakhona ikhuthaza ukuba iTummino v. Hamburg ivule ngoFebruwari 8, 2012.
Ngako-ke, unyaka ka-2012 uqala ngecala lenkundla apho abachasayo befakela isikhalazo sokuvalwa kwesantya esiza kuvumela ukufikelela kwe-OTC kuyo yonke i-levonorgestrel-based based contraceptives (zombini kunye neenguqu ezimbini zeepilisi) ngaphandle kweyiphi iminyaka okanye imida yokuthengisa. ..
- NgoFebruwari 16, 2012: UMgwebi uKorman uphakamisa "uMyalelo wokuBonisa isizathu" ofuna ukwazi "ukuba kungani i-FDA ingafanele ilandelwe ukwenza iPlani B ifumaneke kulabo bantu abafundiswayo kwiinkqubo ze-FDA banokuqonda xa kusetyenziswa Isicwangciso B sifanelekileyo kwaye imiyalelo yokusetyenziswa kwayo. "
- Ngomhla ka-9 Matshi 2012: Teva ufake iifom yesicelo esichitshiweyo sokwenza isicwangciso B Isinyathelo esinye Isinyathelo sitholakalayo ngaphandle komyalelo kubasebenzisi abaneminyaka engama-15 nangaphezulu kwaye ukuvumela ukuba kufumaneke kwicandelo locwangciso lwezonyango (kunye neikhondom , namhlanje i-Sponge , i-spermicide , iikhondom zamabhinqa , kunye neentsimbi ) kunokuba zilandele i-counter-pharmacy counter, kodwa ubungqina beminyaka buya kufuneka xa kuhlolwa.
- NgoJulayi 12, 2012: I-FDA iyavuma ukusebenzisa ngokukhawuleza kokusetyenziswa kokukhusela kwe- Next Choice One Dose , i-tablet eyodwa efana neCwangciso B Isinyathelo esinye Isibonelelo, kunye nezibonelelo ze-OTC / emva kwe-counter countermatics isimo saloo minyaka eli-17 ubudala okanye ngaphezulu ngaphandle kwemithi.
Ngaloo ndlela, ndikukhokelela kunyaka ka-2013, kunye nokupheliswa kwembali yokukhulelwa kwangxamisekileyo, kunye nohambo lwayo olude kwaye lukhuni ukuya kwindawo apho namhlanje ...
- NgoFebhuwari 22, 2013: I-FDA iyavuma ukusetyenziswa kwexesha eliphuculweyo lwe- My Way , ipilisi enye efana neCwangciso B-Inye-nyathelo, kunye ne-OTC / emva kwe-counter countermatics status yabo kule minyaka eyi-17 ubudala okanye ngaphezulu ngaphandle kwemithi.
- Ngo-Ephreli 5, 2013: UMgwebi weSithili sase-US u-Edward R. Korman uphendule isinqumo se-FDA sokukhanyela i-Petition Petition kunye nemiyalelo yokuba i-arhente ineentsuku ezingama-30 ukuvumela ukuthengiswa kwe-contravative-based-based-levonorgestrel ngaphandle kokunciphisa iminyaka. Wabonisa izigqibo zikaNobhala uSebelus ngokuthi "ukhuthazo lwezopolitiko, unobunzululwazi olungenasisiseko, kunye nokuchasene nenkonzo yangaphambili." IJaji uKorman nayo yamgxeka i-FDA ngenxa yokulibaziseka kwayo, ekugxininiseni ukuba bekuyiminyaka engaphezu kwe-12 ukususela kwi-Petition Citizen.
- Ngo-Aprili 30, 2013: Ngosuku okanye ezimbini phambi kokuba i-agrithi iya kufuneka ukuba ilandele i-Epreli 5, 2013, inkundla yenkundla, i- FDA "ngokufanelekileyo" iyavuma isicelo sokulungiswa kweTeva , ukuvumela ukuthengiswa kweSicwangciso B Isinyathelo esinye Ishedyuli ngaphandle imithi yabasetyhini abaneminyaka eli-15 nangaphezulu. Ukugcina ngokuqinisekileyo ukuba imvume yeTeva isicelo "esizimeleyo kuloo mbambano" kwaye "isigqibo sabo asihlose ukujongana nesigwebo sejaji." Ngengozi ukuba i-FDA inikeze isicelo seTeva ngeli xesha? Hmm?
- Ngomhla ka-1 kuMeyi 2013: Iintsuku ezimbalwa ngaphambi kokuba i-FDA ibonise ukuthobela isigwebo sika-Jaji-Korman sika-Ephreli 5, iSebe lezobuLungisa lase-United States licela kwaye licela ukuba lihlale lilandelelana, ngoko ke i-FDA ayiyi kufumana inxaxhiso yenkundla.
- Ngomhla we-10 kuMeyi 2013: UMgwebi uKorman uphika isicelo se-DOJ sokuba ahlale , ebiza le nyathelo "inomdla" kunye nezinye iinjongo ze-FDA ukulibazisa inkqubo yokwenza isigqibo.
- Ngo-Meyi 13, 2013: ISebe lezoBulungisa lifake isibheno sayo kwiNkundla yesiBheno ye-2 yeNkundla yeSibheno eManhattan. INkundla inyanzela ixesha lokugqibela kweJaji likaKorman ukuya kuMeyi 28, 2013.
- NgoJuni 5, ngo-2013: Ijaji le-3 inxusa inkundla inqaba ukunyuswa kwe-DOJ yokuhlala kunye nemiyalelo yokuphakamisa yonke imithintelo yeminyaka kwaye ivumele ukuba iimeko eziza kubakho ngokukhawuleza zithintele iipilisi ezimbini zeepilisi, kodwa kungekhona i-pilice eyodwa. Ukuqhawula isisu - Umyalelo weJaji uKorman kwi-pilisi enye yokukhulelwa ngokukhawuleza ngokukhawuleza ivalwe okwesikhashana ulindele isiphumo sesibheno se-DOJ.
- NgoJuni 10, 2013: I- DOJ yehla isibheno sayo kwaye iyavuma ukuthobela ukuthengiswa kwe-OTC okungapheliyo kweCwangciso B inye-nyathelo elide nje kuphela ukuba i-generics ihlala ikhulile kwaye isemva kwe-counter. I-FDA ibuye icele uTeva ukuba ifake isicelo esongezelelweyo sokucela ukuba kungabikho iminyaka okanye imingcele yokuthengisa.
Umdaniso roll nceda ... umzuzu wenkcazo yokukhulelwa kwangxamisekileyo esiye sikhokelela kuyo - EYE, kuFETEKA apha ...
- NgoJuni 20, 2013: I-FDA iyavuma isiCwangciso seB-One Step for the sales-counter-counter-counter-restrictions. I-arhente iphinde inike iminyaka emithathu kuphela yeTeva yokuthengisa i-B B Inyathelo eli-OTC. Abavelisi bee-1-pilisi ezilinganayo zengeniso zingenise izicelo ze-FDA ezongezelelweyo zokuthengiswa kwee-counter-counter-counter emva kokuba i-patent yeTeva iphelile ngo-Ephreli 2016.
- NgoFebruwari 25, 2014: Ngomzamo wokuvumela ukuba imeko ye-OTC yeCandelo elilodwa elikhethiweyo kunye neNdlela yam (iipilisi ezi-1 eziphambili zokuCwangcisa B isinyathelo esinye), i-FDA ithumela ileta kubenzi beemveliso ezichaza ukuba Isiphakamiso sikaTeva sokuba yedwa "sinqande kakhulu" kwaye "sininzi kakhulu." I-arhente ivume le ndlela yokuvelisa i-generic ingathengiswa ngaphandle kwendawo yokuthengisa okanye imingcele yeminyaka phantsi kwemeko yokuba abakhiqizi babonisa kwileyibhile yemveliso ukuba ukusetyenziswa kwezi ziphulo-mvavanyo zongxamiseko kuhloswe kubasetyhini abaneminyaka eli-17 nangaphezulu. Ukufakwa kwesi senzo ekujoliswe kuyo kwiphakheji ibambelela ekusebenziseni ukuphela kweTeva kuphela kwaye ivumela ukuba ezi ndlela zenzeke zithengiswe ngaphaya kwe-counter, kungekho mfuneko okanye imfuneko yeminyaka.
Imbali yokukhulelwa ngokukhawuleza kubandakanya ukunqoba okubalulekileyo kunye nokutshatyalaliswa kwamanye. Ekugqibeleni, ukufumaneka kwesi sizathu sokukhulelwa kubalulekile njengethuluzi elinye ekukhuseleni ukukhulelwa okungenakulungiswa kunye nokukhipha isisu.
Imithombo:
ISebe lezeMpilo kunye neNkonzo zoLuntu. "Imveliso yeziyobisi zamachiza; Ezinye iinkqubo zokukhulelwa komlomo ezidibeneyo zokusetyenziswa njengendlela yokukhulelwa kwangxamnye nesimo esiphuthumayo "; Isaziso. Register Register . NgoFebruwari 25, 1997; vol 62: akukho 37: 8610-8612. Fi kelelwa ngo 10/11/12.
DG Weismiller. "Ukukhulelwa ngokukhawuleza." Ugqirha wezeMerika waseMelika . 2004 Aug 15; Vol. 70 (4): 707-714. Fi kelelwa ngo 10/11/12.
FDA Newsroom. [Agasti 26, 2005]. "I-FDA yenza isenzo kwiCwangciso B." Ingxelo yomkhomishina we-FDA uLester M. Crawford. Fi kelelwa ngo 10/11/12.
FDA Newsroom. [Apreli 30, 2013]. "I-FDA ivunyelwa iSicwangciso B Isinyathelo esisinye sokunyanga ngokukhawuleza ngaphandle kokufumana imithi yabasetyhini abaneminyaka eli-15 ubudala nangaphezulu." Ukufikelela kwi-10/11/12.
J. Trussell, F. Stewart, F. Guest kunye no RA Hatcher. Iipilisi zokuLawula ngokukhawuleza: Iproposition elula yokunciphisa izilungiso ezingavumelekanga. " Imiba yoCwangciso loNtsapho . 1992; 24: 269-273. Kufumaneka ngokubhalisa kwangasese.
PFA Van Look no H. von Hertzen. "Ukukhulelwa kwangxamisekileyo." IBritish Medical Bulletin . 1993; 49: 158-170. Kufumaneka ngokubhalisa kwangasese.
UP. Murray. [Septemba 9, 2005]. "UClinton, uMurray kunye nama-11 eSenators Bacela i-GAO ukuba ikhuphe uVavanyo lweCwangciso B yokuVunywa kweNkqubo." Ukufikelela kwi-10/11/12.
RL Mackenzie. [Septemba 2, 1998]. "Ukukhusela i-Kit yokuLawula ngokukhawuleza kwe-Kit - iMveliso yokuqala yoLwaphulo oluPhezulu -Vunyelwe yi-FDA." Kufinyeleleka ngo-10/11/12.
I-tummino v. Hamburg (No. 12-CV-763) I-Case: 13-1690 (iNkundla yeBhunga le-US kwiSekisi yesiBili ngoJuni 5 ngo-2013). Fi kelele 6/6/13.
I-Tummino v. Hamburg , No. 12-CV-763 (ERK) (VVP) (EDNY kuMatshi 4, 2013). Fi kelelwa ngo 10/11/13.
I-Tummino v. Torti , 603 F. Ukuncedisa. 2d 519 (EDNY, Mar. 23, 2009). Fi kelelwa ngo 10/11/13.