SUPPLEMENT GMP GUIDELINES FOR "POSITIVE IDENTIFICATION" OF INGREDIENTS may be needed, FDA suggests in an advance notice of proposed rulemaking published in the Feb. 6 Federal Register. In requesting comments on aspects of GMPs that may not have been fully covered in the November 1995 industry-proposed version of supplement GMPs, FDA asks interested parties what might be considered "appropriate testing requirements to provide positive identification of dietary ingredients, particularly plant materials, used in dietary supplements."
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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