FDA Issues Final Guidance on Bispecific Antibody Development Programs - Drug Information Update

If your email program has trouble displaying this email, view it as a web page. 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. View Guidance This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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