FDA INVOKES GMP AUTHORITY FOR IRON SUPPLEMENT UNIT-DOSE PACKAGING proposal in a "supplemental" proposed rule published in the Feb. 16 Federal Register. The notice provides a legal basis for an October 1994 proposed rule that requires child-resistant unit-dose packaging on all products (drugs and dietary supplements) that contain 30 mg or more iron per dosage unit. The supplemental rule, FDA explained, "set[s] forth [the agency's] legal authority" for the proposed rule after the passage of the Dietary Supplement Health & Education Act.
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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.’
It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.
Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.
Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.
