The European Medicines Agency (EMA) has just published guidelines for Industry on the clinical investigation of medicinal products for the treatment of Duchenne and Becker muscular dystrophy.
The EMA is the European equivalent of the FDA in the US and these guidelines are similar in nature to the guidance the FDA published earlier this year. We are reviewing the EMA guidance carefully and comparing it to the draft guidelines by the FDA. We will be in touch with more details after we’ve fully digested the document.
The draft guidance PPMD submitted to the FDA in 2014, with the help of the entire Duchenne community, continues to resonate globally. We strongly believe that knowledge is power and that the only way we can end Duchenne is to educate every single regulatory authority with consistent information.
We’re all in this together.