For Industry

I own a small pharmaceutical business. Am I eligible for, and if so, how do I apply for a PDUFA waiver?

The Agency will waive the application fee for the first human drug application that a small business or its affiliate submits for review (section 736(d) (1) (E) of the FD&C Act). A small business is defined as a business that has fewer than 500 employees, including employees of affiliates. An affiliate is a business entity that has a relationship with a second business entity if one business entity controls, or has the power to control, the other business entity, or a third party controls, or has the power to control, both entities. (Section 735(9) of the FD&C Act).

After a waiver for a first human drug application is granted, the small business is assessed appropriate user fees for all subsequent human drug applications and supplements submitted for review. There are no small business waivers for product or establishment fees.

To be granted a waiver, the small business must submit a written request for the waiver.

The written request should include the following information:

  • The name and address of the entity, including the company name, and the name and telephone number of the contact person for the fee waiver or reduction request
  • Identification of the specific fee for which a waiver, refund, or reduction is requested
  • For an application or supplement fee - the application or supplement number for which the waiver, refund, or reduction is requested, the date the application was submitted, and whether the application requires clinical data for approval
  • The statutory provision under which the waiver or reduction is requested
  • Information and analyses demonstrating that the criteria for the waiver, refund, or reduction of fees are met
  • Date on which payment was or will be made to FDA of the fee for which a waiver or reduction is requested

Waiver requests should be sent to:

CDER PDUFA Staff
Food and Drug Administration
10001 New Hampshire Avenue, Room 3179
Silver Spring, MD  20993-0002

Courier deliveries should be addressed as follows:
CDER PDUFA Staff
Food and Drug Administration
10001 New Hampshire Avenue, Room 3179
Silver Spring, MD  20903

Phone: 301-796-7900
Email:  CDER-PDUFA@fda.hhs.gov

 

Relevant Resources:

Frequently Asked Questions on Prescription Drug User Fees (PDUFA)

Prescription Drug User Fee Act (PDUFA)

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Page Last Updated: 03/23/2015
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