USA – ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications

The Food and Drug Administration (FDA) is issuing this revised draft guidance to describe the process through which prospective generic drug applicants seeking a priority review goal submit complete, accurate facility information in advance of submitting a priority original abbreviated new drug application (original ANDA), prior approval supplement (PAS), PAS amendment, or ANDA amendment (hereafter collectively referred to as ANDA). FDA is revising the draft guidance because, after issuance of the original draft guidance, section 505(j)(11) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (U.S.C. 355(j)(11)) as added by section 801 of the FDA Reauthorization Act of 2017 (FDARA)6 23 resulted in changes to the pre-submission of facility information. Specifically, that provision requires the presubmission of relevant sections of the ANDA as determined by FDA. This permits FDA to utilize the existing process for submission of ANDAs (including electronic Common Technical Document (eCTD) submission format) for the pre-submission of facility information and avoids the duplicative effort by applicants that would have been required if the relevant facility information had to be first submitted as identified in the original draft guidance and then resubmitted, in somewhat different form, in the ANDA itself…