SUPPLEMENTS MAY STATE THAT A BALANCED DIET ALONE MAY NOT BE ADEQUATE for supplying necessary nutrients, FDA said in a Dec. 28 proposed rule covering nutrition labeling for dietary supplements. The agency will allow use of such a statement based on reports by "scientific and consensus groups that there are certain situations in which the use of dietary supplements may be needed for persons to obtain adequate nutrient intakes," the proposal explains.
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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 recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.
