Pregnant Women In Clinical Trials: Investigators Should Justify Exclusion, NIH Official Says
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.
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Agency is removing warning contraindicating use of statins during pregnancy; the move comes after FDA has permitted COVID-19 vaccination of pregnant women and amidst push for their enrollment in clinical trials.
Although UK labeling for the Pfizer/BioNTech vaccine recommends against use in women who are pregnant or breastfeeding, the US FDA’s labeling under an emergency use authorization is not expected to follow suit; agency says developmental and reproductive toxicity studies for some early candidates are nearing completion, but data will not available for EUA decision-making.
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Draft guidance emphasizes postmarket consideration of other data, while advice on premarket trials suggests weighing 'prospect of direct benefit to the pregnant woman and/or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.'