JOINT BIOMARKER SUBMISSION FORM RELEASED BY EMA AND FDA
January 7th, 2015THE FOOD & Drug Administration (FDA), of the USA, and the European Medicines Agency (EMA) have released a form for pharma companies to lodge biomarker and clinical outcome assessments in joint submissions to the two regulators. Manufacturers have to file proposed contexts of use; high level data descriptions; data that applicants plan to obtain from ongoing or future studies, and more.
*www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2014/12/WC500179474.doc
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