FDA publishes guidance on providing regulatory submissions in electronic format addressing pharmaceutical production applications and related submissions in the Federal Register Oct. 19. Guidance outlines filing of NDAs, ANDAs, BLAs, INDs, master files and promotional materials using the electronic Common Technical Document. One in a series of documents, the guidance is intended to facilitate use of the eCTD specifications and provides more specificity than previous guidance documents. The agency is accepting comments...
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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.
