Readers of the GDUFA guidance documents have pointed out the need for clarification on the issue of whether packagers are required to pay annual facility fees. FDA intends to address this issue more fully in future guidance, but wanted to provide as quickly as possible clarification for industry.
ANDA Submissions – Prior Approval Supplements Under GDUFA(PDF - 173KB) ANDA Submissions – Amendments and Easily Correctable Deficiencies Under GDUFA(PDF - 231KB) Draft Guidance for Industry: Content and Format of Abbreviated New Drug Applications
- Draft Guidance: ANDA Submissions -- Refuse-to-Receive Standards (PDF - 476KB)
- Draft Guidance: Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1) (PDF - 244KB)
- Draft Guidance for Industry: Initial Completeness Assessments for Type II API DMFs Under GDUFA (PDF - 137KB)
- Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Please note that the FDA User Fee Corrections Act of 2012 signed into law Oct. 5, 2012 revises GDUFA to enable collection of FY 2013 GDUFA user fees without enactment of an Appropriations Act.) (PDF - 244KB)
- Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and Organizations