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Negócios · 26/08/20251 min de leitura
Determination of Regulatory Review Period for Purposes of Patent Extension; CAMZYOS
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Resumo
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.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →