FDA is working on three guidances to help avoid medication errors due to drug name confusion. The first addresses policy considerations related to the process of submitting trade names, such as what FDA will and will not accept; another guidance provides general recommendations on labeling and packaging issues, including prominence and total drug content; the third will provide more specifics on the analysis and submission of data for trade name review, including possible studies companies could conduct to evaluate look-alike and sound-alike names
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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.
