FDA ‘Consistent’ in Implementing NME Communications

Lilly researchers who evaluated an FDA 2012 program to promote greater transparency and increased communication between the agency and applicants of new molecular entity (NME) NDAs and original BLAs say the agency was consistent in meeting the program goals. Writing in Therapeutic Innovation & Regulatory Science, the researchers say they examined 128 publicly available NME NDA and original BLA approval packages reviewed under the program with the goal to educate regulatory professionals about the content and timing of communications from FDA to the sponsor

The timing of communications was consistent with the 21st-century Desk Reference Guide (DRG), as were the content and format of the mid-cycle communication, the study found.

The researchers found that the DRG and the FDA Manual of Policies and Procedures were reliable resources to predict FDA’s planned actions associated with the review of an NME NDA or original BLA.