The RAPS learning platform provider will be upgrading its security posture. This will take the system off-line from 20 July through the end of the day 23 July. This will affect any Online Course, eBook, and Virtual Program Attendance. Thank you for your patience.
Posted 01 July 2010 | By
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.