GDUFA Federal Register Notices

• October 21, 2016 Public Meeting on GDUFA Reauthorization Federal Register Notice; Request for Comments; Extension of Comment Period; Correction
• October 21, 2016 Public Meeting on GDUFA Reauthorization
• DA Announces Fiscal Year 2017 Generic Drug User Fee Rates
• FDA Announces Fiscal Year 2016 Generic Drug User Fee Rates

• FDA seeks stakeholder participation in periodic meetings on the reauthorization of GDUFA
• June 15, 2015 Public Meeting on GDUFA Reauthorization
• FDA Requesting Comment on Proposed Criteria for “First Generic” Submissions

• Guidance For Industry: ANDA Submissions - Refuse-to-Receive Standards (RTR Standards guidance) (Final Guidance)
• Guidance for Industry: ANDA Submissions - Refuse-to-Receive for Lack of Proper Justification of Impurity Limits (Draft Guidance)
• Generic Drug User Fee Amendments of 2012; Public Hearing on Policy Development; Request for Comments
• Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers
• FDA posts Draft Guidance for Industry: Controlled Correspondence Related to Generic Drug Development
• FDA Announces Fiscal Year 2015 Generic Drug User Fee Rates
• FDA Announces Fiscal Year 2014 Generic Drug Fees
• Federal Register Notice: ANDA Submissions – Prior Approval Supplements Under GDUFA (PDF - 183KB) (7/10/2014)
• Federal Register Notice: ANDA Submissions – Amendments and Easily Correctable Deficiencies Under GDUFA (PDF - 202KB) (7/10/2014)
• Federal Register Notice: Draft Guidance for Industry on Abbreviated New Drug Application Submissions; Content and Format of Abbreviated New Drug Applications; Availability (6/12/2014)
• Federal Register Notice: Improving the Quality of Abbreviated New Drug Application Submissions to the Food and Drug Administration; Establishment of a Public Docket (1/23/2014)
   
• Federal Register Notice: Draft Generic Drug User Fee Act Information Technology Plan (12/26/2013)
   
• Federal Register Notice: Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012 -- Questions and Answers (Revision 1); Availability (9/10/2013) 
   
• Federal Register Notice: Generic Drug Facilities, Sites, and Organizations (4/16/2013)
   
• Federal Register Notice of Generic Drug User Fee—Facility Fee Rates for Fiscal Year 2013 (1/17/2013)
   
• Federal Register Notice: Generic Drug User Fee--Backlog Fee Rate for Fiscal Year 2013 (10/25/2012)
   
• Federal Register Notice: Generic Drug User Fee--Abbreviated New Drug Application, Prior Approval Supplement, and Drug Master File Fee Rates for Fiscal Year 2013 (10/25/2012)
   
• Federal Register Notice of Requirement: Self-Identification of Generic Drug Facilities, Sites and Organizations; (Self-identification information must be submitted by December 3, 2012) (10/2/2012)
   
• Federal Register Notice of Availability: Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical Ingredient Drug Master Files Under the Generic Drug User Fee Amendments of 2012 (10/2/2012)
  • Guidance (PDF, 137 KB)
     
• Federal Register Notice of Availability: Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (8/22/2012)
  • Guidance (PDF, 482 KB)
     
• Federal Register Notice of Availability: Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and Organizations (8/22/2012)
  
  • Guidance
     
• Federal Register Notice of Public Meeting: Generic Drug User Fee Amendments of 2012 (8/22/2012)
   
• Federal Register Notice of Opportunity to Withdraw Abbreviated New Drug Applications to Avoid Backlog Fee Obligations (8/22/2012)
   
• Federal Register Notice: Agency Information Collection Activities; Comment Request; Generic Drug User Fee Cover Sheet; Form FDA 3794 (7/26/2012)