Drug Safety In Pregnant Women: FDA Seeks Alternatives To Registries
This article was originally published in The Pink Sheet Daily
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.
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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
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