Interaction with regulators
macustar is in continuous contact with the regulatory authorities to ensure the approval of the developed and validated outcome measures as clinical endpoints accepted by regulators.
Furthermore, the European Medicine Agency (EMA), an EU wide regulatory agency, has already issued a letter of support for macustar which originates from a joint scientific advice procedure led by the EMA, the US Food and Drug Agency (FDA) and UK’s National Institute of Care and Clinical Excellence (NICE). Recommendations by all three regulatory authorities have already been implemented into the project design.
Recently, the European Medicine Agency (EMA) issued a second letter of support. To sum up, the EMA supported the further conduct of the macustar study which is a great success for all consortium members!