- Clinical use after June 12, 2012, will require an approved marketing application or an expanded access IND.
- From June 12, 2012, until December 12, 2015, investigational use may be permissible if a marketing application is pending. Investigational use after December 12, 2015, will require an IND unless the research is exempt under 21 CFR 312.2(b).
- Research use that does not require an IND will continue to be overseen by Radioactive Drug Research Committees operating in accordance with 21 CFR 361.1(c).
It is important to understand the distinction between investigational use, which encompasses any research that involves assessments of safety and/or efficacy, and research use, explicitly defined as “basic science research, and not research that is intended for immediate therapeutic, diagnostic, or similar purposes, or to determine the safety and effectiveness of the radioactive drug or biological product for such purposes (i.e., the research cannot constitute a clinical trial for the product)”.
The agency recommends submitting any public comments by May 14, 2012, to ensure they can be considered before work begins on the final version of this guidance.