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{"id":174197,"date":"2021-06-07T10:00:43","date_gmt":"2021-06-07T13:00:43","guid":{"rendered":"https:\/\/oatlantico.com.br\/?p=174197"},"modified":"2021-06-06T20:53:44","modified_gmt":"2021-06-06T23:53:44","slug":"anvisa-aguarda-documentos-sobre-butanvac","status":"publish","type":"post","link":"https:\/\/oatlantico.com.br\/anvisa-aguarda-documentos-sobre-butanvac\/","title":{"rendered":"Anvisa diz que aguarda documentos para deliberar sobre Butanvac"},"content":{"rendered":"A Anvisa (Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria) informou neste domingo (6), que o processo de pedido de anu\u00eancia dos estudos cl\u00ednicos da vacina Butanvac contra a Covid-19, desenvolvida pelo Instituto Butantan, est\u00e1 em fase de \u201cexig\u00eancia\u201d.<\/p>\n
Isso significa que a ag\u00eancia reguladora aguarda ainda o envio complementar de documenta\u00e7\u00e3o necess\u00e1ria para que a an\u00e1lise cient\u00edfica seja conclu\u00edda.<\/p>\n
\u201cO Instituto Butantan se comprometeu a entregar as informa\u00e7\u00f5es faltantes at\u00e9 segunda-feira, dia 07\/06\/2021. Os dados referem-se \u00e0 an\u00e1lise de qualidade da vacina\u201d, diz a Anvisa em nota divulgada neste domingo.<\/p>\n
Em entrevista no dia 26 de maio, o diretor executivo do Instituto Butantan, Rui Curi, disse que havia uma expectativa de que o \u00f3rg\u00e3o regulador desse uma resposta sobre o in\u00edcio dos testes cl\u00ednicos da Butanvac at\u00e9 esta segunda.<\/p>\n
Na ocasi\u00e3o, o governador de S\u00e3o Paulo, Jo\u00e3o Doria, cobrou \u201csenso de urg\u00eancia\u201d diante do quadro causado pela pandemia da Covid-19.<\/p>\n
Segundo a Anvisa, a entrega da documenta\u00e7\u00e3o \u00e9 condi\u00e7\u00e3o essencial para permitir a finaliza\u00e7\u00e3o da an\u00e1lise. \u201cSem a entrega das informa\u00e7\u00f5es n\u00e3o \u00e9 poss\u00edvel a conclus\u00e3o do processo.\u201d<\/p>\n
O Butantan deu entrada junto \u00e0 Anvisa no dia 26 de mar\u00e7o do Dossi\u00ea de Desenvolvimento Cl\u00ednico de Medicamento da Butanvac. \u201cTranscorridos 72 dias at\u00e9 este domingo, 6\/6, e ap\u00f3s intensas trocas de informa\u00e7\u00f5es oficiais em que foram detalhadas as informa\u00e7\u00f5es complementares necess\u00e1rias, a Ag\u00eancia disp\u00f4s de 24 dias para trabalhar na efetiva an\u00e1lise, e passou os outros 48 dias aguardando o cumprimento das exig\u00eancias e a complementa\u00e7\u00e3o das informa\u00e7\u00f5es do Butantan\u201d, diz a Anvisa em nota.<\/p>\n
Informa\u00e7\u00f5es ND+<\/h6>\n","protected":false},"excerpt":{"rendered":"
A Anvisa (Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria) informou neste domingo (6), que o processo de pedido de anu\u00eancia dos estudos cl\u00ednicos da vacina Butanvac contra a Covid-19, desenvolvida pelo Instituto Butantan, est\u00e1 em fase de \u201cexig\u00eancia\u201d. Isso significa que a ag\u00eancia reguladora aguarda ainda o envio complementar de documenta\u00e7\u00e3o necess\u00e1ria para que a an\u00e1lise cient\u00edfica […]<\/p>\n","protected":false},"author":45,"featured_media":174198,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[190],"tags":[5],"acf":[],"yoast_head":"\n
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