SNM and ACNP Leadership Present Information on Radioactive Drugs at FDA Meeting

November 18, 2004

SNM and ACNP Leadership Present Information on Radioactive Drugs at FDA Meeting

SNM and ACNP leadership contributed six presentations to the "Radioactive Drugs for Certain Research Uses" meeting of the FDA’s Radioactive Drug Research Committee (RDRC) on November 16 in Rockville, MD. The public meeting was called by FDA’s RDRC staff to garner public input on the need to modify the conditions set forth in 21 CFR 361.1 that ensure the safe use of radioactive drugs for basic research purposes without an Investigational New Drug application. The meeting continues FDA’s outreach to the nuclear medicine community to re-energize the activities of RDRCs.

SNM President Mathew Thakur, PhD, presented SNM’s suggestions to the FDA on pharmacology issues. Henry Royal, MD, SNM’s immediate past president, presented SNM's views on radiation dose limits for adult subjects and the exclusion of pregnant women from some research studies. Michael Gelfand, MD, SNM past president, presented SNM’s suggestions for pediatric studies under an RDRC. ACNP/SNM Joint Government Relations Committee Chair Terry Beven, MD, along with Dr. Thakur, provided FDA RDRC staff with suggestions from both ACNP and SNM on membership and administrative issues relating to RDRC.