Rules and Regulations. Notice; correction
/register/2025/08/26/2025-16273·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Agency: Food and Drug Administration, HHS
Action: Notice; correction
Citation: FR Doc. 2025-16273 · Docket Nos. FDA-2023-E-1548; FDA-2023-E-1550
Summary
The Food and Drug Administration (FDA or the Agency) published a notice in the Federal Register of February 29, 2024. After review of the calculation of the applicable regulatory review period of the biologic product CAMZYOS (U.S. patent numbers 9,181,200; 9,585,883) in that notice, FDA has determined that a revision of the supplementary information section is warranted. This notice corrects the applicable regulatory review period language.
Supplementary Information
Correction In the Federal Register of February 29, 2024 (89 FR 14880), on page 14881, second column, under II. Determination of Regulatory Review Period, the first two sentences of the section should be corrected to read as follows: FDA has determined that the applicable regulatory review period for CAMZYOS is 2,722 days. Of this time, 2,266 days occurred during the testing phase of the regulatory review period, while 456 days occurred during the approval phase. Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2025-16273 Filed 8-25-25; 8:45 am]