Early Access to Experimental Medicine

EMD Serono’s Commitment to Early Access to Experimental Medicine.

Our Commitment

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).

We believe 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. We believe 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. To learn more about clinical studies visit www.clinicaltrials.gov and search by company, disease or medicine.

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, we may provide patients with access to unapproved or investigational medicines outside the clinical studies process via Early Access. For more information from the FDA about early access to experimental medicine in the U.S., click here.  For instructions on viewing all expanded (“early”) access programs listed in clinicaltrials.gov click here.

Requesting Early Access

If a treating physician determines a patient is not eligible or able to participate in a clinical study and the patient has exhausted all available treatment options, the physician may contact us to make a formal request for experimental (i.e. investigational) medicine on behalf of the patient.  This will allow the physician to work with our physicians to evaluate the request.

Physicians seeking experimental medicine on behalf of their patients may contact us at earlyaccess@emdserono.com. Once we have received the request, we will respond within five business days. If the request is approved by us, the FDA will need to grant final approval before we can ship the experimental medicine to the requesting physician.

For more information on our External Position Statement on Early Access to Experimental Medicine, click here.


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