Expedited drug review procedures final rule

Executive Summary

Due imminently based on FDA's projected regulatory agenda. In keeping with the agenda's usual optimism, FDA, in the Oct. 29 Federal Register, provided Oct. 31 as the date for publication of the final rule for expedited review of drugs for treating life-threatening/debilitating illnesses. The agenda also indicated that the interim final rule for retention of drug samples used in bioequivalence or bioavailability studies will issue in the near future. Final action is expected in May for an amendment to the IND regs that would include reasons for ceasing distribution of an experimental drug under a parallel track mechanism. According to the agenda, FDA expects to issue in March the final rule for food labeling regulations that will allow use of certain health messages.