DIETARY SUPPLEMENT GMPs APPLICABLE ONLY TO FINISHED PRODUCTS URGED by Amway's Nutrilite Division in a June 5 submission to FDA on the agency's Feb. 6 advance notice of proposed rulemaking on dietary supplement Good Manufacturing Practices ("The Tan Sheet" Feb. 10, pp. 2-5). Nutrilite "strongly believes that any GMP issued should apply to the manufacture of dietary supplements and not to the manufacture of dietary ingredients," the comments state. Nutrilite manufactures its botanical ingredients and finished dietary supplement products.
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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.’
The UK drug regulator is collecting data to establish whether patients who are hospitalized for acute pancreatitis after taking a GLP-1 drug have a genetic predisposition to this side effect. If a “clear link” is found, the MHRA would consider regulatory action.
While titanium dioxide is banned as a food additive in the EU, the European Medicines Agency has convinced the European Commission to allow its continued use in the many thousands of medicines in which it is currently used.
Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.
