On October 17, 2016, the FDA published the final guidance for industry, “ANDA Submissions - Prior Approval Supplements Under GDUFA.” This final guidance is intended to assist applicants preparing to submit prior approval supplements (PASs) and related amendments. The guidance explains how the Generic Drug User Fee Amendments of 2012 (GDUFA) relate to PAS submissions and clarifies how FDA handles PASs and amendments for ANDAs subject to the GDUFA performance metric goals.
The draft version of this guidance was published in July 2014. The final guidance addresses comments received in the public comment period, and includes the following updates:
- Clarification of FDA’s Electronic Common Technical Document (eCTD) criteria
- Removal of references to the “time since last inspection” approach to inspection scheduling, which no longer represents FDA policy
- Listing of information required on the first page of a PAS submission
- Edits to the “Grouped Supplements” section to reflect recently published revisions to MAPP 5015.6, “Review of Grouped Product Quality Supplements,” and the publication of the Comparability Protocols guidance
The guidance is posted at: http://www.fda.gov/downloads/
Drugs/ GuidanceComplianceRegulatoryIn formation/Guidances/UCM404441. pdf