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