Department of Health and Human Services
Food and Drug Administration
- [Docket No. FDA-2019-N-0895]
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that VEKLURY (remdesivir), manufactured by Gilead Sciences, Inc., meets the criteria for a material threat MCM priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Sadove, Office of Counterterrorism and Emerging Threats, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-8515, Fax: 301-796-8615, email: EUA.OCET@fda.hhs.gov.