Frequently Asked Questions
Do I need to send adverse effects associated with the use of the radioactive drug to the RDRC?
The Stony Brook University Radioactive Drug Research Committee is responsible for the review and approval of all radioactive drug research projects which fall under the U.S. Food and Drug Administration (FDA) regulations as specified in 21 Code of Federal Regulations Part 361.1 involving investigational or non-routine clinical uses of radioactive drugs without New Drug Applications (NDA) filed with the FDA or without Investigational New Drug (IND) numbers issued by the FDA. Institutional Review Board approval is also required before initiation of the study.
The radiopharmaceutical used does not have an IND, an ANDA or FDA approval. The research that qualifies for RDRC review is considered basic science research and is done for the purpose of advancing scientific knowledge. This type of research is:
- intended to obtain basic information regarding the metabolism (including kinetics, distribution, dosimetry, and localization) of a radioactive drug or regarding human physiology, pathophysiology, or biochemistry,
- notintended for immediate therapeutic, diagnostic or similar purposes (e.g. preventive benefit to the study subject from the research), and
- notintended to determine the safety and effectiveness of a radioactive drug in humans.
Visit https://www.fda.gov/drugs/scienceresearch/ucm574897.htm for more information regarding requirements and guidelines for RDRC research.
If the intent of the studies is to develop a diagnostic drug, an IND is appropriate. One of the requirements of § 361.1 is that the research is not intended to determine the safety and effectiveness of the radioactive drug in humans as a therapeutic, diagnostic, or preventive medical product. This does not mean that initial basic research studies could not be done under an RDRC if they meet the requirements in § 361.1. However, once you intend to perform clinical trials to determine the safety and effectiveness of the drug for purposes of diagnosis, an IND will be required.
Section 361.1(d)(8) requires that the investigator immediately, but no later than 7 calendar days, report to the RDRC ALL adverse effects in the research study. The RDRC must report immediately, but no later than 7 calendar days, to FDA all adverse reactions probably attributable to the use of the radioactive drug in the research study. That is, the RDRC need not confirm a causal relationship between the drug and the event, but a likelihood that the event and the use of the drug were related.
The Stony Brook University RDRC meets on the first Monday of every month. In the case of a holiday, the meeting will be rescheduled.
Any new studies should be submitted to the RDRC coordinator Emily Capak at least 2 weeks prior to the meeting date. Any responses/Adverse Events/amendments should be submitted at least 1 week prior to the meeting date.
Once the study has been reviewed at the meeting, the correspondence letter will be drafted and sent to the RDRC Chair for signature. The RDRC coordinator Emily Capak will then email the final letter to the study team within the same meeting week. Please note that there is no expedited procedure for RDRC studies. Any responses submitted will need to be reviewed at the following meeting.