Fee-WaiverQuestion: Are there statistics where we can maybe read, how many Biotechs got a FDA approval, which received a fee waiver before approval?
WAIVERS, REDUCTIONS, AND REFUNDS
16. Are there any waivers of user fees?
Under section 736(d) of the FD&C Act, a waiver may be granted for one or more fees where:
a waiver or reduction is necessary to protect the public health;
assessment of the user fees would present a significant barrier to innovation due to limited resources or other circumstances;
the fees will exceed the anticipated present and future costs incurred by FDA for conducting the process for the review of the new drug applications for the person;
before October 1, 2002 only, assessment of the fee for an application or a supplement filed under section 505(b)(1) pertaining to a drug product would be inequitable because an application for a product containing the same active ingredient filed by another person under section 505(b)(2) could not be assessed user fees.
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17. Are there any waivers of fees specifically for small businesses?
Yes. 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).
the term 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).
To be granted a waiver, the small business must submit a written request for the waiver.
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.
For additional information on user fee waivers, go to the PDUFA web page and look under Guidances.
Quelle:
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBus…