Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Are there instances in which the FDA has designated more than one reference standard for generic product development? My understanding is that the FDA designates only one reference standard. If that reference standard is changed (due to citizen petition or FDA decision), the former reference standard loses its designation when the alternative product is designated as the reference standard. 

Is my understanding correct?

Thank you!

You may find this FDA presentation helpful in answering your question - your understanding is correct.

https://www.fda.gov/media/102266/download

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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 25-Feb-2021 20:15
From: Anonymous Member
Subject: Generics: Reference Standard

This message was posted by a user wishing to remain anonymous

Are there instances in which the FDA has designated more than one reference standard for generic product development? My understanding is that the FDA designates only one reference standard. If that reference standard is changed (due to citizen petition or FDA decision), the former reference standard loses its designation when the alternative product is designated as the reference standard.

Is my understanding correct?

Thank you!