This message was posted by a user wishing to remain anonymous
Based on the information provided, I don't see any reason it wouldn't be waived. My recent experience: I applied for a waiver 90 days before the filing date and it was not approved until one month after the NDA was filed. We paid the filing fee and once the waiver was approved we requested the refund. That took three months.
In a previous experience, we applied too early and the waiver expired before the NDA was filed. The company had to pay the fee and re-apply for the waiver. They eventually got a refund.
The moral of the story is: Make sure you apply early enough, but not too early. Or, be prepared to pay the fee and request a refund.
Original Message:
Sent: 13-Jul-2021 20:28
From: Anonymous Member
Subject: PDUFA small business waiver
This message was posted by a user wishing to remain anonymous
What is the likelihood of a PDUFA small business waiver being accepted as long as number of employees are <500, no previous drug product has been approved/marketed, and we are submitting our first NDA? Note that there are no subsidiaries. I would assume close to 100%, but please share your advice/experience.
Thank you in advance!