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

Drug Safety In Pregnant Women: FDA Seeks Alternatives To Registries

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

You may also be interested in...



Vaccine Safety In Pregnancy Among Possible Mini-Sentinel Projects

But first, FDA needs to determine whether Mini-Sentinel can support a methodological framework for studying pregnancy outcomes.

FDA Seeks More Data On Drug Exposure In Pregnancy, But Is Mining Insurance Records The Best Approach?

The Food and Drug Administration has asked outside investigators to begin tracking pregnant women's drug exposures and birth outcomes in hopes of generating better information for the pregnancy and lactation section of drug labels, although the agency is hedging its bets on the best way to compile the data

Registries Rising: FDA Looking At TNF Inhibitors; AHRQ Updates Standards

The FDA Amendments Act of 2007 gave the agency many new safety powers and the potential for promotional restrictions and post-marketing fines have understandably received much industry attention. But FDA also appears to be drawing upon its beefed-up authority to increase use of a much older, low-tech safety effort: the patient registry

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS076882

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