Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

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

Executive Summary

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

You may also be interested in...



UCB Cimzia Advances Pregnancy And Lactation Labeling For Biologics

First industry-sponsored pharmacokinetic studies evaluating transfer of a biologic through placenta and breast milk support US FDA approval of new labeling describing low level of Cimzia in fetuses and infants – and highlight the pregnancy and lactation research challenges being explored by task force under 21st Century Cures Act. 

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.

Salix Will Need To Dissolve Metozolv ODT Convenience Claims With Corrective Advertising Campaign; FDA Warning Letter Silent On REMS

An effort by Salix Pharmaceuticals to tout advantages for its orally disintegrating metoclopramide product Metozolv ODT has ended with a need to run a corrective advertising campaign

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS052091

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