Upcoming Meetings: FDA's Obstetrics and Gynecology Devices Panel
This article was originally published in The Gray Sheet
Executive SummaryFDA's Obstetrics and Gynecology Devices Panel: Meeting July 22 and 23 at the Gaithersburg Marriott in Gaithersburg, Maryland, and July 24 at 9200 Corporate Blvd., Rockville, Maryland. On July 22-23, the panel will discuss "appropriate recommended testing" for intrapartum electronic fetal monitoring. Also on July 23, the panel will consider a premarket approval application for an implantable stent "used for in utero treatment of fetal postvesicular uropathy" and a PMA "for a silicone barrier contraceptive device." Discussion of the contraceptive device will continue on July 24. For more information, contact FDA's Alfred Montgomery at 301/594-1180...
You may also be interested in...
Draft policy moots crowdfunding for high-cost rare diseases alongside financial support for those "amenable to one-time treatment" but falls way short of some patient groups' expectations.
India’s Hilleman Laboratories says it’s aiming to develop an affordable vaccine that will target pregnant women in low- and middle-income countries to prevent Group B Streptococcus, a potentially fatal infection passed to babies during childbirth.
Chi-Med’s surufatinib has come up trumps in a second trial in neuroendocrine tumors, after the monitoring committee recommended an early halt following achievement of its PFS target in the pancreatic setting.