Department of Health and Human Services September 8, 2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the issuance of approval of product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that VABYSMO (faricimab- svoa), for which a priority review voucher was redeemed, was approved January 28, 2022.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products,'' replacing the December 2014 draft guidance of the same name. This draft guidance, once finalized, will assist sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and supplements to such applications, who are planning to conduct clinical studies in pediatric populations. In addition, this draft guidance, once finalized, will assist investigators in the design and planning of, and Institutional Review Boards in the assessment of, clinical studies in pediatric populations.