Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all - I need your advice please.  Company A is a small company who received a small business waiver for the PDUFA user fees for their first NDA.  The NDA has been accepted by FDA for review and is in the early part of the review process.  Company A has recently been purchased by Company B and is now a stand-alone subsidiary of Company B.  Company B would not qualify for the small business waiver.  Will FDA revoke the small business waiver for Company A when the change in ownership is reported to the NDA?  Thanks in advance for any guidance on this situation!

This message was posted by a user wishing to remain anonymous

Hi Anon

See the guidance on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.

Does a small business waiver have an expiration date?

If a small business waiver is granted, the applicant should submit its human drug application within 1 year after the date of the SBA determination. The reason for the 1 year time frame is that the circumstances supporting a small business waiver may change rapidly. For example, an applicant could merge with a larger company and therefore no longer be considered a small business. Similarly, an applicant could purchase an NDA from an unaffiliated company and, therefore, would have a drug product that has been approved under a human drug application and introduced into or delivered for introduction into interstate commerce.

FDA understands that unforeseen circumstances may delay submission of an application. If an applicant is granted a small business waiver and is not able to submit the application within 1 year of the SBA determination, the applicant may ask FDA to extend the expiration date. If an extension is requested, the Agency will examine its records and will work with SBA to confirm that the applicant still meets the criteria for a small business waiver. If the criteria are no longer met, the extension request will be denied.

This indicates that the waiver is fine. It was correctly granted to a small business, with the understanding that the business might not remain small.

Original Message:
Sent: 22-May-2023 15:00
From: Anonymous Member
Subject: FDA PDUFA User Fee Waiver Revocation?

This message was posted by a user wishing to remain anonymous

Hi all - I need your advice please.  Company A is a small company who received a small business waiver for the PDUFA user fees for their first NDA.  The NDA has been accepted by FDA for review and is in the early part of the review process.  Company A has recently been purchased by Company B and is now a stand-alone subsidiary of Company B.  Company B would not qualify for the small business waiver.  Will FDA revoke the small business waiver for Company A when the change in ownership is reported to the NDA?  Thanks in advance for any guidance on this situation!

I agree that once the NDA is submitted with a waiver in place, the waiver will not be revoked. To my knowledge, there is not even a process in place that such an event could happen.

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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 22-May-2023 15:00
From: Anonymous Member
Subject: FDA PDUFA User Fee Waiver Revocation?

This message was posted by a user wishing to remain anonymous

Hi all - I need your advice please.  Company A is a small company who received a small business waiver for the PDUFA user fees for their first NDA.  The NDA has been accepted by FDA for review and is in the early part of the review process.  Company A has recently been purchased by Company B and is now a stand-alone subsidiary of Company B.  Company B would not qualify for the small business waiver.  Will FDA revoke the small business waiver for Company A when the change in ownership is reported to the NDA?  Thanks in advance for any guidance on this situation!