Pseudoephedrine is a BCS class 3 compound. What is needed to get a biowaiver for an EU country (FDA has a more stricter view on BCS class 3)? Would dissolution data work? I can't imagine conducting a BE study for an OTC drug, but can't find justification to waive one. Thank you! ## Although I'm not totally familiar with this topic, I did come across a brief article of information that I thought could be of assistance. Unfortunately it's not European-based, but I hope it helps shed some light on the FDA's level of strictness: "Biopharmaceutics Classification System (BCS) is a regulatory mechanism through which drug developers and generic companies can obtain a waiver of clinical bioequivalence studies, also called a biowaiver. According to the 2000 FDA BCS Guidanc...