News / Press Release

Are There Specific Criteria Used to Determine Whether Patients Can Receive an Investigational Drug Outside the Clinical Trial Setting?

April 15, 2017

To be considered a candidate for receiving an investigational drug outside of a clinical trial drug investigation setting, patients usually must:

Importantly, the potential risks involved with using an investigational drug must not outweigh the potential benefits on either the patient’s quality of life or survival rate.

FDA Regulations Concerning Patient Access to Investigational Drugs

Under the Federal Food, Drug and Cosmetic Act, a patient is eligible to pursue an investigational drug for the diagnosis, monitoring or treatment of their cancer diagnosis as long as long as:

TD2, a world-class drug development service specializing in getting the most innovative and best oncology treatments to patients in need, can help physicians fill out applications for patients to access investigational drugs. We can also provide information about regulatory must-knows.

About Translational Drug Development (TD2)

TD2 is an oncology development organization that provides innovative services for oncology-focused companies. Using a dedicated team of professionals with broad experience and understanding in drug development, TD2 is uniquely positioned to support improved and accelerated development of medicines for life-threatening oncology diseases. TD2 applies rigorous and high-throughput translational preclinical development, combined with regulatory affairs expertise, to customize clinical trial design and execution. TD2’s suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process and to the acceleration of patient access to promising treatments. For more information, visit www.TD2inc.com.

About TD2

TD2 is an oncology development organization that provides innovative services for oncology-focused companies. Using a dedicated team of professionals with broad experience and understanding in drug development, TD2 is uniquely positioned to support improved and accelerated development of medicines for life-threatening oncology diseases. TD2 applies rigorous and high-throughput translational preclinical development, combined with regulatory affairs expertise, to customize clinical trial design and execution. TD2’s suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process and to the acceleration of patient access to promising treatments. For more information, visit www.TD2inc.com.

Contact
Tara Franks
602-358-8322
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