Anuencia em Processo de Pesquisa Clinica de ORPC's-Medicamentos

11:56 Jul 23, 2015 

I was able to find historical and new material in FDA's website using drug product, so I do not believe this term will be replaced in a near future. It has a more strict meaning than medicine, since medicine is the common word for medication. We do not see "medicine application" or "new medicine application" in FDA's website for instance.

I am not saying medicine is wrong, and I do believe it is a more international language. But I also know the US has some peculiar use of language they like to keep. So, my point is that drug product is a possible term in regulatory setting, only here.

And, by the way, I believe there is another important point to solve in this question. The term anuência, in my opinion, does not refer to a consent from the CRO, as it would have no relevant meaning in the regulatory setting. It seems to refer rather to an approval from the regulatory body of any issue related to a study/trial conducted by a CRO. What do you think of that?

01:07 Jul 23, 2015 

suspeito que essa anuência se refira à aprovação da CRO pela ANVISA, não ao consentimento dela em participar da pesquisa. Isso é um título de peticionamento que os laboratórios fazem junto à agência. Logo, me parece fazer mais sentido que peticionem a autorização para incluir a ORPC no estudo, ou para que a agência autorize o início de um estudo conduzido por uma ORPC, que para informar do consentimento dela em conduzir o estudo para o laboratório.

http://portal.anvisa.gov.br/wps/content/Anvisa Portal/Anvisa...