The European Medicines Agency (EMA) has published a strategy for implementing international guidelines on managing post-approval safety data. EMA’s strategy applies to the first revision of the ...
European authorities have issued an updated strategy for the regulation of drugs in the EU, citing recent advances in manufacturing technology and methods as drivers for the revision. The updated ...
With the aim of replacing guidance from 2002 on quality of water for pharmaceutical use, the European Medicines Agency (EMA) is offering new draft guidance for industry on the pharmaceutical use of ...
Management indicated plans to provide both regulatory and clinical trial updates on blarcamesine for indications beyond Alzheimer’s, including Parkinson’s disease, Rett syndrome, and Fragile X.
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