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
UsernamePublicRestriction

Pregnancy Registries May Use External Comparison Groups – Final Guidance

Executive Summary

Pregnancy exposure registries may use external comparison groups, including background rates, surveillance systems and other registries, FDA said in its 1pregnancy registry final guidance

You may also be interested in...



FDA Poised To Require More Rigorous Study Of Drug Use In Pregnancy

With new guidance expected, internal comparison groups, better protocols and potential generic industry involvement are some features that appear likely for the next generation of post-marketing requirements to assess drug safety in pregnancy.

Drug Safety In Pregnant Women: FDA Seeks Alternatives To Registries

Stakeholder meeting will address poor enrollment rates and other issues that undermine the utility of pregnancy registries, as well as the use of alternatives, such as case control studies and claims-based database studies.

FDA “Xes” Letter Categories For Pregnancy Labels; Data Collection Drives Reg

FDA's proposed rule to update the format of the pregnancy and lactation sections of drug labeling does not require the firms collect new data about their products, but the agency is hoping to use various mechanisms to encourage them to do so

Related Content

UsernamePublicRestriction

Register

PS040552

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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