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 ...
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.
Key market opportunities include developing comprehensive risk-based pharmacovigilance (PV) audit strategies aligned with EMA and FDA guidelines. Focus areas involve designing PV audit plans, risk ...
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