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
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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.
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