USDA APHIS NOTICE: VS Memorandum 800.112 Guidelines for Validation of In Vitro Potency Assays

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USDA APHIS NOTICE: VS Memorandum 800.112 Guidelines for Validation of In Vitro Potency Assays

Author: Sherry Ward, AltTox

The Center for Veterinary Biologics (CVB) recently added [05/07/2015] VS Memo 800.112 to its website, which may be accessed by clicking the following link: CVB Newly Published Information (http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalhealth?1dmy&urile=wcm%3apath%3a%2Faphis_content_library%2Fsa_our_focus%2Fsa_animal_health%2Fsa_vet_biologics%2Fct_vb_newly_published_info).

This memorandum provides guidance concerning the information a firm should provide when submitting a new potency assay for consideration by the Center for Veterinary Biologics (CVB). This memorandum further clarifies information found in title 9, Code of Federal Regulations (9 CFR), sections 102.3(b)(2)(ii) and 113.8(a)(3)(ii), and in Veterinary Services (VS) Memorandum No. 800.50.