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Regulatory Update

Posted 01 July 2010

The US Food and Drug Administration (FDA) recently announced the availability of Guidance for Industry: Bioequivalence Recommendations for Specific Products.' This guidance describes a new process for making available recommendations on how to design product-specific bioequivalence (BE) studies to support Abbreviated New Drug Applications (ANDAs). Applicants planning to carry out such studies in support of their ANDAs can access BE study guidance on the FDA website. FDA believes that making this information available on the Internet will streamline the guidance process and will provide a meaningful opportunity for the public to consider and comment on product-specific BE study recommendations.


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