FDA Spokesperson: Meeting on Columbia's Pre-Term Birth Gel is Set for January 20th

View more here. Agenda The Committee will discuss the benefits and risks of New Drug Application (NDA) 22-139, progesterone gel 8%, Columbia Laboratories, Inc., for the proposed indication of "reduction of risk of preterm birth in women with short uterine cervical length regardless of other risk factors in the mid-trimester of pregnancy.” The uterine cervix is the mouth of the uterus (or womb) leading into the vagina (or birth canal). The benefit/risk discussion will focus on the adequacy of the demonstration of efficacy in the US population.