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Mallinckrodt Policy on Expanded Access Program for Investigational Products
Mallinckrodt is an innovation-driven biopharmaceutical company focused on improving outcomes for underserved patients with severe and critical conditions. The purpose of this policy is to describe Mallinckrodt's Expanded Access Program for the use of investigational products outside of a clinical study, when certain conditions are met.
It is Mallinckrodt's policy to be able to provide appropriate and ethical access to its investigational products to patients under certain defined circumstances prior to marketing authorization, but outside of the planned clinical research program. Such Expanded Access Programs, or EAPs (often called "Compassionate Use" programs), are for exceptional circumstances only.
All expanded access programs must be conducted in agreement with applicable country-specific legal and regulatory requirements related to providing an investigational product under expanded access. A request for EAP will only be considered if it meets the criteria for consideration listed below.
Criteria for Consideration of a Request for EAP
Mallinckrodt reviews all requests on a case-by-case basis against the following criteria:
The patients have a serious, life-threatening or chronically debilitating disease;
The investigational product presents sufficient evidence of efficacy such that a clinically meaningful benefit may be expected;
The investigational product presents sufficient evidence of safety indicating that patients would not be exposed to unreasonable risk;
There is no comparable or satisfactory alternative therapy to diagnose, monitor or treat the disease or condition; and
The patients are ineligible for, or otherwise unable to participate in, a clinical trial for the product.
There is adequate supply of the investigational product to meet all needs for patients enrolled in ongoing clinical studies, and that designating investigational product for an expanded access treatment use will not compromise supply or otherwise postpone providing the new treatment, once approved, to the broader patient population; and
Providing expanded access to an investigational product will not negatively jeopardize the initiation, conduct, or completion of clinical investigation(s) and the overall development program to support registration of the product.
A physician or institution may apply for access to a Mallinckrodt investigational product in the pre-approval stage of development by contacting this email: CompassionateUse@mnk.com.
The requestor may expect to receive acknowledgment of the request within three business days.
Mallinckrodt may request more detailed information from the physician or institution in order to fully evaluate a request.
Any physicians or institutions participating under an EAP must agree to comply with all relevant laws, regulations and requirements, including any reporting requirements (such as relating to the maintenance and release of treatment records and data to Regulatory Agencies, and to Mallinckrodt, as specified/required), supervise administration of the investigational product, obtain informed consent and/or assent, adhere to Good Clinical Practice guidelines, and other procedures as outlined by Mallinckrodt.
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