WASHINGTON, Aug. 20 -- Food and Drug Administration has issued a notice called: Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability.
The notice was published in the Federal Register on Aug. 20 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document titled "Potency Assessment of Active Immunotherapy Products." The draft guidance document provides recommendations for developing assays to assess potency as a part of a potency assurance strategy for active immunotherapy products (ACTIMPs). When finalized, this guidance will describe the FDA's current thinkin...