Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Pregnant Women In Clinical Trials: Investigators Should Justify Exclusion, NIH Official Says

Executive Summary

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.

You may also be interested in...



Statin Label Change May Signal Broader US FDA Shift On Drug Use During Pregnancy

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.

US Label For COVID-19 Vaccine Will Not Recommend Against Use In Pregnancy

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Draft guidance emphasizes postmarket consideration of other data, while advice on premarket trials suggests weighing 'prospect of direct benefit to the pregnant woman and/or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.'

Topics

Related Companies

UsernamePublicRestriction

Register

PS143876

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel