New FDA Guidance on User Fee Waivers, Reductions, and Refunds - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

New FDA Guidance on User Fee Waivers, Reductions, and Refunds


ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA has issued a guidance titled User Fee Waivers, Reductions and Refunds for Drug and Biological Products that outlines FDA's policies for issuing waivers, refunds, or reductions in prescription drug user fees. The newly issued guidance is a revision of a 1993 guidance titled Draft Interim Guidance Document for Waivers of and Reductions in User Fees.

Under the Prescription Drug User Fee Act (PDUFA), FDA is authorized to assess application fees for certain human drug and biological product applications or supplements. In addition, FDA can assess annual product fees for certain approved drug and biological products, and annual establishment fees for the facilities in which those products are made.

Under PDUFA, FDA will grant a waiver or reduction in fees if an applicant meets the eligibility criteria under one of the following provisions:

  • A waiver of reduction is necessary to protect the public health
  • The assessment of the fee would present a significant barrier to innovation because of limited resources available to the person or other circumstances
  • The applicant is a small business submitting its first human drug application to the secretary for review.

The guidance describes the types of waivers and reductions available under the user-fee provisions of PDUFA and describes FDA’s current thinking on the criteria for meeting eligibility requirements for each type of waiver.  A section on exemptions and refunds discusses orphan designated products, applications submitted by state or federal government entities, and instances where an application was withdrawn before any substantial work was performed by the agency.  The guidance also describes the procedures for requesting waivers, refunds, or reductions, and discusses the procedure for reconsiderations and appeals of FDA decisions on such requests.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
27%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
8%
All of the above.
46%
No government involvement in patient treatment or drug development.
7%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here