At EMD Serono, we are committed to developing new medicines for patients with life-threatening, chronic or seriously disabling illnesses or diseases. Therefore, our focus is on enrolling patients in clinical trials to obtain the data required for review and approval by regulatory authorities, including the U.S. Food and Drug Administration (FDA).
EMD Serono believes the best way to fulfill this commitment is to conduct clinical studies to assess the safety and effectiveness of experimental medicines which, if proven, will allow us to obtain drug approval from regulatory authorities and provide patients with broad access to these new medicines. EMD Serono believes that patients should be encouraged to participate in clinical studies, the goal of which is to secure approval of new, safe and effective medicines for the broadest number of patients.
We recognize that some patients with life-threatening, chronic or seriously disabling illnesses and diseases may not be eligible or able to participate in a clinical study and may want access to the experimental medicine being tested in the clinical study. In certain circumstances, EMD Serono may provide patients with access to unapproved or investigational medicines outside the clinical trials process via Early Access.
For more information on EMD Serono’s External Position Statement on Early Access to Experimental Medicine, click here