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Portfolio Media. Inc. 111 West 19th Street, 5th Floor New York, NY 10011 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customer service law360.noncomplying With Expanded Access Policy
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Complying with expanded access refers to ensuring that access to investigational medical products outside of clinical trials complies with regulatory requirements.
Healthcare providers, pharmaceutical companies, and researchers may be required to file complying with expanded access depending on the situation.
Complying with expanded access can be filled out by providing detailed information about the investigational product, the patient to receive it, and the reason for seeking access.
The purpose of complying with expanded access is to ensure that patients who cannot participate in clinical trials have a chance to access investigational medical products under certain circumstances.
Information such as the product name, dosage, treatment plan, patient information, and informed consent details must be reported on complying with expanded access.
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