Expanded Access Policy

Expanded Access Policy

Norroy Bioscience Co., Ltd. (NORROY) is an R&D-oriented biotech enterprise focused on the development and commercialization of radiopharmaceutical theranostics and automated synthesizers & functional modules for radiopharmaceutical manufacturing for both research‑and‑development and GMP‑compliant environments.

NORROY conducts human clinical trials for its investigational products to generate safety and efficacy data as required to support the regulatory approval by the U.S. Food and Drug Administration (FDA) and regulatory authorities in other countries and subsequent wider accessibility to patients.

With the enactment of the FDA Reauthorization Act and 21st Century Cures Act, the FDA greenlights the early access of investigational medicinal products on an Expanded Access basis for patients facing serious or immediately life-threatening diseases or conditions who are ineligible or unable to participate in a clinical trial and may not have options for alternative therapies. Meanwhile, the statute aims to make it easier for patients and physicians to understand a drug manufacturer’s policies regarding the availability of its investigational drug products for expanded access, how to request access, and how requests will be handled.

We acknowledge the necessity of an expanded access program, and our goal is to provide expanded access to our investigational products at the appropriate time in development. Considering the stage of development of the investigational products, NORROY is seeking to retain its capacity of manufacturing and drug supply to assure adequate supply for ongoing clinical trials and development programs to generate data on the safety and efficacy of the investigational products in order to support regulatory approval and make the products accessible to the broader patient population. At the present stage, NORROY is unable to provide any of its investigational drug products on an expanded access or right-to-try basis.

Contact Details

If you have any questions about our expanded access policy, please contact NORROY via email at: bd@norroybioscience.com

For Additional Information

• For more information on the available clinical trials, please visit clinicaltrials.gov and search company, condition, or treatment.

• For additional information on Expanded Access, please visit the U.S. Food and Drug Administration at: Expanded Access | FDA.

The issuance of this policy by NORROY is not a guarantee of access to any specific investigational product by any individual patient. In line with the 21st Century Cures Act, NORROY reserves the right to amend this policy at any time.

Norroy Bioscience Co., Ltd.

Address: No. 35-208, Changjiangnan Road, Xinwu District, Wuxi, JiangSu, China. 214000