Access to Investigational Drugs
Access to Investigational Drugs
Ferring conducts clinical research with a focus on various diseases and conditions within reproductive health, women’s health, urology, gastroenterology, endocrinology and orthopedics.
Enrolling in a clinical trial is the primary way for patients to access Ferring investigational drugs prior to regulatory approval. Ferring posts details regarding its clinical trial activities in the clinical trial registry and database on ClinicalTrials.gov. This publicly accessible website is provided by the U.S. National Library of Medicine (NLM) and offers up-to-date information for a wide range of diseases and conditions.
Patients interested in participating in a clinical trial are advised to contact their physician or a healthcare professional to determine if participation is appropriate for them.
Compassionate Use (also known as Expanded Access)
Ferring recognizes that there may be patients facing serious or life-threatening diseases who may not qualify for an ongoing clinical trial, but who may benefit from an investigational drug. For these patients, Ferring may be able to provide access through a compassionate use program. To be eligible for consideration for such a program, the following criteria must be met:
- The patient has a disease or condition that is “serious” or “immediately life-threatening,” and there is no comparable or satisfactory alternative treatment available to the patient. The patient must not be eligible for and must not have access to a current Ferring clinical trial.
- Ferring determines that the potential benefits of treatment with the investigational drug outweigh the potential risks to the patient. This assessment takes into consideration the condition of the patient and the sufficiency of safety and efficacy data for the investigational drug. The potential risks must be reasonable given the disease or condition to be treated.
- Providing the investigational drug will not interfere with the initiation, conduct, or completion of Ferring clinical trials or development of the drug.
- Providing the investigational drug complies with applicable local legal and regulatory requirements. This includes any necessary reviews and approvals by health authorities and institutional review boards/ethics committees, as well as use of the drug under the supervision of a licensed physician.
Ferring reviews applications for access to investigational drugs that meet these criteria. Access to Ferring investigational drugs under a compassionate use program is only available through the patient’s physician.
Patients interested in Ferring investigational drugs must work through their treating physicians to see if they are eligible to enroll in a clinical trial or receive the drug through a compassionate use program.
Physicians seeking more information about eligibility for access to investigational drugs should contact Ferring Medical Affairs at 1-888-FERRING (1-888-337-7464), or via our contact page.
Ferring anticipates acknowledging receipt of requests made to Ferring Medical Affairs within three (3) business days.