The US Food and Drug Administration's tentative approval process and the global fight against HIV.
CONCLUSIONS: In this paper, we describe the importance and implementation of USFDA's tentative approval process to review ARVs for resource-constrained settings. We also highlight the impact of patents and exclusivities on review of HIV drugs under tFDA and illustrate the concepts using a new HIV drug as an example.
PMID: 29232052 [PubMed - in process]
Source: Journal of the International AIDS Society - Category: Infectious Diseases Tags: J Int AIDS Soc Source Type: research
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