ABSTRACT

Drug Development: Pathway for Approving Antibacterial and Antifungal Drugs for Patients with Limited Treatment Options is Infrequently Used, Report to Congressional Committees   [open pdf - 384KB]

From the Highlights: "It is estimated that at least 2.8 million antibacterial and antifungal-resistant infections occur each year in the United States, and more than 35,000 people die as a result, according to the Centers for Disease Control and Prevention. The development of new antibacterial and antifungal treatments is one strategy to address the threat of antimicrobial resistance. The 21st Century Cures Act, enacted in 2016, established LPAD [limited population pathway for antibacterial and antifungal drugs] to help facilitate the approval of certain antibacterial and antifungal drugs. FDA [Food and Drug Administration] oversees the approval of such drugs. The 21st Century Cures Act includes a provision for GAO [Government Accountability Office] to review and report on FDA's LPAD activities. This report describes (1) the extent to which LPAD changes FDA's drug approval process, (2) the extent to which drug developers have sought to use LPAD for drugs under development, and (3) stakeholders' and FDA's views on the effectiveness of LPAD in benefiting the development and approval of antibacterial and antifungal drugs."

Report Number:
GAO-22-105042
Publisher:
Date:
2021-11
Copyright:
Public Domain
Retrieved From:
Government Accountability Office: https://www.gao.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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