Who Can Provide Access to Investigational Drugs Being Developed by Pharmaceutical Companies?
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:
- Age of the patient
- Sex of the patient
- Type of cancer diagnosed
- Date of the cancer diagnosis
- A list of all the previous oncology therapies tried on the patient
- Current clinical status of the patient
- Intended dose of the investigational drug requested
- Schedule of the requested investigational drug
- Relevant laboratory data
- Any concomitant cancer drugs that could be implicated in a drug-drug interaction
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.