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You are here: Home / Nerac Insights / Articles / Drug Safety Updates – Regulations and FDA Guidance for Industry

Drug Safety Updates – Regulations and FDA Guidance for Industry

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By Stephen Buxser, Ph.D., Nerac Analyst,
Originally Published: November 28, 2016

For drugs licensed for sale in the United States, as well as elsewhere in the world, there are requirements for periodic literature updates/reviews. These reviews require resources to capture all scientific publications describing health or safety issues for a particular drug during a specified time period. Although such reports have been a part of the landscape for marketed drugs for many years, the procedures for carrying out the searches have not been particularly clear. This article describes the legal requirements for drug safety and efficacy reporting.

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