NDMA URGES RDI FINAL RULE EFFECTIVE DATE EXTENSION in April 11 comments to FDA. The rule, published in the Dec. 28, 1995 Federal Register along with several proposed implementing regs for the Dietary Supplement Health & Education Act, establishes Reference Daily Intakes for vitamin K, selenium, manganese, chromium, molybdenum and chloride ("The Tan Sheet" Jan. 1, p. 22).
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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 European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
The European Medicines Agency has recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy, despite the product securing approvals in the US and other markets.
