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  5. GDUFA Accomplishments
  1. Generic Drug User Fee Amendments

GDUFA Accomplishments

As the Generic Drug User Fee Amendments of 2012 (GDUFA) approaches the first anniversary of its enactment, the program has achieved a number of significant milestones. The program, designed to speed access to safe and effective generic drugs by supplementing federal funds with industry user fees, has:

  • Made significant strides in reducing the backlog of pre-GDUFA applications and enhancing review efficiencies. 

The Office of Generic Drugs has:

  • Completed scientific review of approximately 40 percent of GDUFA backlog applications since program launch. 
     
  • Implemented a number of improvements designed to increase the quality of communications between FDA and industry during the review process   Improvements include issuing complete response letters reflecting full division-level review of deficiencies from all relevant review disciplines.
     
  • Conducted completeness assessments for over 900 drug master files and launched the creation of a publicly available for reference list to expedite review of applications containing referenced active pharmaceutical ingredients.
     
  • Organized and led a public meeting to discuss regulatory science priorities to expand the availability and quality of generic drugs and solicit input from stakeholders. 
       
  • Streamlined the hiring process to recruit new scientific reviewers, project managers, investigators, and support staff.  FDA expects to meet its ambitious year one GDUFA hiring goal by bringing on board at least 25 percent of GDUFA program hires by October 1. 
     
  • Facilitated development of the most comprehensive list of generic drug industry participants.  To date, more than 2,200 manufacturing and testing facilities have submitted self-identification information to FDA enhancing the quality and transparency of the generics industry.  The list is available to download on FDA’s GDUFA web page (www.fda.gov/gdufa).   
     
  • Engaged in unprecedented outreach efforts to educate and inform industry participants and other stakeholders about provisions of the Act.
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    • Hosted a GDUFA small business conference, a public meeting, educational sessions, and webinars. 
       
    • Disseminated materials regularly to over 150,000 industry participants and stakeholders.
       
    • Created GDUFA web page and posted updated materials regularly. 
       
    • Reached out to generic industry trade associations and other industry stakeholders to spread the word.
       
    • Contacted all generic industry facilities in FDA records to alert them of the Act.
       
    • Published guidance documents in advance of program launch to give industry as much time to prepare as possible.
       
    • Participated in numerous industry-sponsored events.   
       
  • Collected over $255 million in first year user fees to finance the program including new hires and infrastructure improvements.

 

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