IMMEDIATE: Time Sensitive DRAFT VS Memorandum 512 - In Vitro Serial Release Potency Test for Complete Product Containing Clostridium chauvoei
USDA Animal and Plant Health Inspection Service sent this bulletin at 09/04/2018 04:55 PM EDT
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The Center for Veterinary Biologics (CVB) recently added Draft VS Memorandum 512 - In Vitro Serial Release Potency Test for Complete Product Containing Clostridium chauvoei - to its website for a 3-week comment period, which may be accessed by clicking the following link: Draft Guidance Documents for Comment. CVB will consider all comments received by September 24, 2018, before finalizing the guidance document. The purpose of this memorandum is to provide guidance to licensees, permittees, and applicants concerning the CVB policy for obtaining an exemption to use an in vitro potency test, in place of the current Standard Requirement test for releasing serials of product containing Clostridium chauvoei antigen.
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