Preparing FDA Submission Data Packages

Dhiren Patel

Yuguang Zhao

M.S., Senior Vice President, Programming and Development

Tiepu Liu

M.D., Ph.D., President, Global Biometrics

The implementation of electronic data standards advances FDA efforts by enabling more timely and effective regulatory reviews of submissions and their corresponding data. This white paper describes the evolution of relevant standards and provides recommendations for best practices in planning and preparing FDA submission data packages.


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