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The European Medicines Agency (EMA)

 

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Realising the therapeutic potential of MDMA

16 June 2021 | By

Psychedelic drugs are gaining popularity in the pharmaceutical R&D sector because of their apparent benefits for people suffering with neuropsychiatric disorders - and those which are resistant to existing therapies in particular. In this article, Imperial College London’s Professor David Nutt discusses the evidence underlying the development of psychedelic therapies…

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Navigating pharmacovigilance complexity in the US and EU: notes for biotechs

15 June 2021 | By ,

Pharmacovigilance obligations present significant challenges for biotechs. Small companies face the same rigor as large pharma - and it does not help that there is divergence between the requirements of the FDA, the EU and its member states. Here, seasoned pharmacovigilance experts and non-executive advisors to Arriello, Eric Caugant in…