The United States Food and Drug Administration (FDA) regulatory response to combat neglected tropical diseases (NTDs): A review.

ABSTRACT: The availability and accessibility of safe and effective drugs, vaccines, and diagnostics are essential to reducing the immense global burden of neglected tropical diseases (NTDs). National regulatory authorities, such as the United States Food and Drug Administration (FDA), play an essential role in this effort to ensure access to safe and effective medical products by working within a set of legal frameworks and regulatory functions. However, medical product development for NTDs remains neglected, as combating NTDs is not a viable commercial market for pharmaceutical companies. To spur research and development (R&D) of NTD products, the US government has authorized various programs and policies to engage pharmaceutical companies, many of which provide FDA with the legal authority to impl

SUBMITTER: Mukherjee S 

PROVIDER: S-EPMC9836280 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature