Zvokudya zveApmma
Chikafu chezvokurapa chinotsanangurwa muOrphan Drug Act neU.S. Food and Drug Administration (FDA) se "zvokudya zvakagadzirwa kuti zvidyiwe kana kuti zvinotungamirirwa zviri pasi pechirongwa chechiremba uye izvo zvinotarisirwa kugadziriswa kwezvokudya zve chirwere kana chirwere chinoshandiswa noutano hwakasiyana-siyana, hunobva pane zvakagadzirwa nesayenzi, inogadzwa nehutano hwekurapa. "
Izvi zvakasiyana nechiremba wako achikuudza kuti udye zvokudya zvishoma zvakabikwa kana kuwedzera maviggies mune zvekudya kwako. Zvokurapa ndezvokudya izvo zvinoita zvirevo zvehutano zvakananga uye zvinotarisirwa kugadzirisa zvakakwana kudya kunodiwa nechirwere kana chirwere. Zvokudya izvi zvakanyatsorongwa kuitira kuti zvigadzirise zvidikanwi zvemurwere.
Kushandisa Lunglaid semuenzaniso, mazinga eukotriene ndiyo inotarirwa nevana vane chirwere chisina kudzora chetema . Suplena chirwere chekurapa chinotarisa varwere vane chirwere chisingaperi chepfungwa.
Iwe Unoda Here Kuona Chiremba Kuti Ushandise Chikafu Chirapa?
Ehe. Nhungamiro ye FDA inoratidza kuti kudya kwechiremba kunofanirwa kushandiswa paunenge uri pasi pekurapa kwechirwere chechirwere chikafu chinotarisirwa kubata. FDA inofunga kuti zvakakosha kuti iwe uri kuongororwa nguva dzose nekuda kwechirwere chechirwere chisingagumi seyemafi uye kuti iwe unowana mirayiridzo yekuti ungashandisa sei chikafu chekurapa kubva kumutsigiri wako wehutano.
Kunyange zvazvo chiremba, chinonakidza, chisingadiwi, kutarisira kweOrphan Drug Act uye FDA ndeyekuti iwe uchaona chiremba wako nguva dzose uye kuti chirwere chako chiri pasi pekutarirwa kwechiremba.
Zvokudya Zvokurapa Zvinodzorwa neDWD?
Kwete. Sezvokudya hazvisi mishonga haisi kutongerwa naDDA uye haufaniri kubvunzurudzwa kwepamusika kana kubvumirwa sezvimwe zvinodhaka zvemidzimu zvakadai se:
- Inhaled Steroids
- SABAs- pfupi iri kuita beta agonist
- Kubata kwenguva refu Beta Agonist (LABA)
- Leukotriene Modifiers
- Oral Steroids
- Cromolyn Sodium Uye Nedocromil
- Kusanganiswa Kwezvinhu Sezvakaita Advair uye Symbicort
- Immunomodulators
- Methylxanthine
Zvokurapa zvakadai seLunglaid kazhinji zvinotumidzwa sa GRAS kana G nesimba R akaziva s S s akafa. Kuti FDA ipe chiziviso ichi, FDA inoda kuti mukoti aratidze kuchengeteka zvakakwana nenzira imwecheteyo kuti zvokudya zvinotarisirwa kushandiswa. Izvi kakawanda zvinoda kuti makambani apinde nenzira dzakafanana iwe unogona kuona kana zvinodhaka zvichiongororwa kuti zvigamuchirwe naDDA. Izvi zvinogona kusanganisira zvidzidzo zvechigadzirwa mumhuka uyewo zvidzidzo zvakabudiswa nevarwere uyewo zvidzidzo zvisiri kushandiswa uye nedzimwe dhenda.
Ndezvipi Zvimwe Zvido Zvinowanikwa Kune Zvokurapa?
Zvimwe zvinhu zvezvokudya zvechiremba zvinoongororwa neDFA mukudzivirirwa kweVatengi veUnited States. Chero kambani inoshandiswa, kutakura, kana kuchengetedza kudya kwechiremba inofanira kutora neCDA. Purogiramu yekuteerera iripo yekuita kuti hutano hwakakodzera hwekugadzira uye hutongi huvepo kune zveUnited States Zvokudya zvakagadzirwa kuburikidza nenzvimbo yekushanyira zvivako Uyezve, chikafu uye microbiological tsanangudzo yezvokudya zvechiremba zvinowanikwa kune zvese zvekurapa.
Zvokurapa zvechiremba zvinowanikwawo kune mamwe mazita ekuisa mabhuku akadai sezvenyu zvakakwana zvezvose zvinoshandiswa.
> Sources:
> US Food and Drug Administration. Draft Guidance for Industry: Frequently Asked Questions About Medical Foods; Yechipiri Edition.