FDA Announces Availability of COVID-19 Guidance – Drug Information Update

If your email program has trouble displaying this email, view it as a web page. FDA Announces Availability of COVID-19 Guidance on Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity Today, the U.S. Food and Drug Administration is announcing the availability of a guidance entitled, "COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity." FDA is issuing this guidance to assist sponsors in the development of monoclonal antibodies (mAbs) and other therapeutic proteins for use as COVID-19 therapeutics and to provide more detailed recommendations to drug developers with the goal of facilitating more complete submissions. The guidance describes how potency assay methods required for release and stability testing can be shown to assess comprehensively known or potential mechanism(s) of action of the product. The testing methods should also be sufficiently sensitive to demonstrate lot-to-lot consistency. In addition to release and stability methods, additional methods that demonstrate the biological function(s) of the product may be needed for characterization and comparability studies. This guidance applies only to mAbs and other therapeutic proteins designed to bind to viral receptors on host cells, inhibit viral entry, and/or elicit Fc-mediated effector function. This guidance does not apply to vaccines, hyperimmune globulins, gene therapies, cell therapies,  convalescent plasma and other non-therapeutic medical products.  Learn More 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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