EMA and FDA release joint biomarker submission form

Published: 21-Jan-2015
Regulatory

Manufacturers must file proposed contexts of use, high level data descriptions and more


The US Food & Drug Administration (FDA) 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.

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