FDA: Generic Drug User Fee Act (GDUFA) Program Performance Goals and Procedures – Draft Guidance

GDUFA calls for FDA to develop new data submission standards

Review metric goals (described below) only apply to submissions made electronically, following the eCTD format in effect at the date of submission.

Industry will submit necessary information in electronic format to FDA using appropriate standards to be specified by the agency or as specified in statute.

To find more information please click here

http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf