On June 11, 2010, FDA announced the availability of a guidance entitled “Bioequivalence Recommendations for Specific Products.” This document “explained the process that would be used to make product-specific bioequivalence (BE) recommendations available to the public on FDA’s Web site.” The process, defined in the original guidance, was adopted by FDA in an attempt to disseminate product-specific BE recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations.
FDA collects draft recommendations, which are posted on its website and announced in the Federal Register from time to time, and asks the public to submit comments within 60 days of the announcement. After the comment period is closed, “FDA considers any comments received and either publishes final recommendations or publishes draft recommendations,” which are then available for comment.
On June 30, 2015, FDA announced the most recent recommendations in the Federal Register. Both new and revised draft guidances with product-specific recommendations were available from the Agency earlier this week. These “recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs),” and include:
Do these recommendations apply to your drug? We know following the rules and regulations as they change can be difficult, and that is why we are here to help. We can work with you to ensure your product(s) are compliant and you are up to date with all FDA regulations. For more information about our services and how we can help you, please contact us.