Pregnant Women In Clinical Trials: US FDA Lays Out Different Considerations For Premarket, Postmarket
Draft guidance emphasizes postmarket consideration of other data, while advice on premarket trials suggests weighing 'prospect of direct benefit to the pregnant woman and/or fetus.'
You may also be interested in...
Enrollment-boosting strategy backed by industry rep at Duke-Margolis meeting as FDA official suggests having sponsors develop study plans for pregnant and lactating women with ‘elements of’ the requirement for pediatric studies.
Agency’s postmarketing requirements to assess Vyleesi risk in pregnant and lactating women highlight the changes catalyzed by draft guidances issued in April.
After US FDA's Oncologic Drugs Advisory Committee voted to delay approval of Karyopharm's multiple myeloma drug Xpovio, the company submitted some data from the Phase III BOSTON trial, which prompted the FDA to award an accelerated approval for a narrower indication.