The European Medicines Agency (EMA) on 9 September proposes updating its guideline on developing drugs for treating bipolar disorder (BD) to reflect new medical understanding of the disease.
The guidance would replace the current 23-year-old version issued in 2001. EMA said it made several changes to reflect information in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). EMA originally announced plans to update the guidance in a 2016 concept paper. (RELATED: European Regulatory Roundup, Regulatory Focus 4 August 2016)…
