News / Press Release

Who Can Provide Access to Investigational Drugs Being Developed by Pharmaceutical Companies?

April 1, 2017

The FDA, in conjunction with the sponsor drug company, is tasked with providing access to pharmaceutical investigational drugs. Physicians must request access to the investigational drug form both the FDA and the drug’s sponsor company. The request must have the following important patient information:

Access to Investigational Drugs and the NCI

The National Cancer Institute (NCI) also plays a role in providing access to investigational drugs being developed by pharmaceutical companies. NCI plays the role of a sponsor for many, but not all, investigational drugs moving through the FDA approval process. NCI maintains communication with all the physicians who are participating in clinical trials for the investigational drug, and any physician wishing to obtain the product for a patient under special exemption must first obtain approval from NCI.

For more information about investigational new drugs, patients and physicians should consider reviewing the NCI’s 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, a world-class drug development service specializing in getting the best and most innovative oncology treatment to patients in need, can also provide information. Our regulatory team is comprised of physicians, scientists, project managers and regulatory experts with extensive experience in FDA regulations, pre-Investigational New Drug (IND) applications and IND strategies, IND submissions and FDA regulated trials.

We specialize in addressing the unique hurdles confronted by each program. Services include consulting in: Chemistry, Manufacturing, and Controls (CMC); Good Laboratory Practices (GLP); and Toxicology/Pharmacology Support Services. We also perform IND-related services and other regulatory filings.

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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