Pregnancy Registries May Use External Comparison Groups – Final Guidance
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...
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.
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'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