Utshintsho luqhubela phambili inkqubela.Xa kuziwa kubutsha kuphuhliso lwamachiza amatsha kunye neemveliso zonyango lwebhayoloji, Iziko le-FDA loVavanyo lweZiyobisi kunye noPhando (CDER) lixhasa ishishini loxubo mayeza kuwo onke amanqanaba enkqubo.Ngokuqonda kwayo isayensi esetyenziselwa ukudala iimveliso ezintsha, ukuvavanya kunye neenkqubo zokuvelisa, kunye nezifo kunye neemeko ezilungiselelwe ukunyanga iimveliso ezintsha, i-CDER ibonelela ngeengcebiso zenzululwazi kunye nokulawula ezifunekayo ukuzisa unyango olutsha kwiimarike.
Ubukho bamachiza amatsha kunye neemveliso zebhayoloji zihlala zithetha iindlela ezintsha zonyango lwezigulane kunye nenkqubela phambili yokhathalelo lwempilo kuluntu lwaseMelika.Ngesi sizathu, i-CDER ixhasa ukusungula izinto ezintsha kwaye idlala indima ephambili ekuncedeni ukuqhubela phambili uphuhliso lwamachiza amatsha.
Nyaka ngamnye, i-CDER ivuma uluhlu olubanzi lwamachiza amatsha kunye neemveliso zebhayoloji:
1. Ezinye zezi mveliso ziimveliso ezintsha ezingazange zisetyenziswe kwiklinikhi.Apha ngezantsi kukho uluhlu lwamaqumrhu amatsha emolekyuli kunye neemveliso ezintsha zonyango zebhayoloji ezivunywe yi-CDER ngo-2021. Olu luhlu aluqukethe izitofu, iimveliso ze-allergenic, igazi kunye neemveliso zegazi, i-plasma derivatives, i-cellular kunye ne-gene therapy iimveliso, okanye ezinye iimveliso ezivunyiweyo ngo-2021 ngu. Iziko loVavanyo lweBiologics kunye noPhando.
2. Ezinye ziyafana, okanye zihlobene, neemveliso ezivunyiweyo ngaphambili, kwaye ziya kukhuphisana nezo mveliso kwindawo yentengiso.Jonga Drugs@FDA ngolwazi malunga nawo onke amachiza avunyiweyo e-CDER kunye neemveliso zebhayoloji.
Amachiza athile ahlelwa njengamaqumrhu amatsha emolekyuli ("NMEs") ngeenjongo zokuphononongwa kwe-FDA.Uninzi lwezi mveliso ziqulethe iimoieties ezisebenzayo ezingavunywanga yi-FDA ngaphambili, nokuba sisithako esinye sechiza okanye njengenxalenye yemveliso edibeneyo;ezi mveliso zihlala zibonelela ngonyango olutsha olubalulekileyo kwizigulana.Amanye amachiza abonakaliswe njenge-NMEs ngeenjongo zolawulo, kodwa nangona kunjalo aqulathe i-moieties esebenzayo esondeleleneyo ne-moieties esebenzayo kwiimveliso ezivunywe ngaphambili yi-FDA.Umzekelo, i-CDER ihlela iimveliso zebhayoloji ezifakwe kwisicelo phantsi kwecandelo lama-351 (a) loMthetho weNkonzo yezeMpilo kaRhulumente njengee-NME ngeenjongo zokuphononongwa kwe-FDA, nokuba i-Arhente ivume ngaphambili i-moiety esebenzayo enxulumeneyo kwimveliso eyahlukileyo.Ukuhlelwa kwechiza kwe-FDA njenge "NME" ngeenjongo zokuphonononga kwahlukile kwisigqibo se-FDA sokuba ingaba imveliso yechiza "liqumrhu elitsha lekhemikhali" okanye "NCE" ngaphakathi kwentsingiselo yoMthetho woKutya, iChiza, kunye neCosmetic.