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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A new pilot aims to take Brazil closer to ‘digital transformation.’
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.
The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.
