Zdrowie i gospodarka · 4/19/2019
Bispecific Antibody Development Programs; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Bispecific Antibody Development Programs." This draft guidance provides recommendations to assist industry and other parties involved in the bispecific antibody drug development process. The draft guidance focuses on general regulatory and scientific considerations for bispecific antibodies, but not on development of a particular bispecific antibody. Industry and other stakeholders are encouraged to engage FDA to discuss their individual bispecific antibody under development.