Zdrowie i gospodarka · 19/04/2019

FDA Releases Draft Guidance for Industry on Bispecific Antibody Development Programs

The Food and Drug Administration (FDA) has released a draft guidance for industry on bispecific antibody development programs, providing recommendations for industry stakeholders involved in the drug development process. The guidance focuses on general regulatory and scientific considerations for bispecific antibodies, and the FDA encourages stakeholders to discuss their individual bispecific antibody projects with the agency.