What if the References listed drug changed strength? [Regulatives / Guidelines]

posted by jag009  – NJ, 2016-05-20 19:26 (3187 d 07:23 ago) – Posting: # 16344
Views: 3,149

Hi all,

If an agency (FDA/EMA or etc) updates the BE guidance to switch the Reference Listed Drug (RLD) to a higher strength, is it possible to claim biowaiver for the higher strength based on proportionality if one already has an approval on the drug product based on BE studies conducted at lower strength RLD -> The previous BE guidance involved a lower strength RLD.

In short, what I am asking is can biowaiver be claimed for higher strength?

Thanks
John

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