|  FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS | | FDA Issues Final Guidance on Bispecific Antibody Development Programs Today the U.S. Food and Drug Administration issued a final guidance, Bispecific Antibody Development Programs. This final guidance provides recommendations for industry and other parties involved in developing bispecific antibodies, which are antibody-based products that target more than one antigen. These recommendations include general regulatory and scientific considerations for bispecific antibodies. Industry and other stakeholders can engage FDA to discuss their individual bispecific antibody under development. With regard to changes from the draft version of this guidance, this final guidance clarifies quality, nonclinical, and clinical considerations when developing bispecific antibodies. Bispecific antibodies have potential advantages over other therapies, as they can target multiple disease-modifying molecules with one drug. Additional guidance is warranted regarding the regulatory pathway to evaluate bispecific antibodies. Read the guidance at: Bispecific Antibody Development Programs | | | The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. | | | |
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