News / Press Release

Are All Investigational Drugs Available Through an Expanded Access or Special Exemption Mechanism?

March 4, 2017

When it comes to oncology drugs, not all investigational drugs are available through an expanded access or special exemption mechanism. The main factors affecting an investigational drug’s availability outside of a clinical drug investigation include:

The most difficult part about participating in an expanded access program is getting access to the drug itself. Not all investigational drugs can provide the same benefits for the same patients, and a risk-benefit analysis has to be performed for each patient before an expanded access or special exemption mechanism can be deemed appropriate.

Additionally, an investigational oncology drug that’s too early on in the clinical drug investigation process would likely not have demonstrated a safe or even positive benefit.

Different pharmaceutical companies have different criteria for which investigational drugs can be used for which patients. The FDA is unable to compel a pharmaceutical company to offer such drugs to patients at all, and the agency has its own set of requirements.

Requirements for Access to Expanded Access Investigational Drugs

Under the Federal Food, Drug and Cosmetic Act (FD&C Act), a patient can pursue an investigational drug for the diagnosis, monitoring or treatment of cancer, provided that:

For more information about investigational new drugs, consider consulting the National Cancer Institute’s (NCI) PDQ database to track the status of ongoing studies. NCI's Cancer Trials website, along with information specialists at NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237), are also available to provide further information.

TD2 specializes in getting the best oncology treatments to patients who need them the most. Contact us for more information.

For more information about investigational new drugs, consider consulting the National Cancer Institute’s (NCI) PDQ database to track the status of ongoing studies. NCI's Cancer Trials website, along with information specialists at NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237), are also available to provide further information.

TD2 specializes in getting the best oncology treatments to patients who need them the most. Contact us for more information.

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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