Topicals, generic [Regulatives / Guidelines]

posted by The Outlaw Torn – Europe, 2013-04-01 10:03 (3826 d 17:14 ago) – Posting: # 10319
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Good morning folks,

It seems the new guideline hasn't removed the need to conduct a BE study (for safety reasons) for opthalmic solutions that may contain an ingredient that is absorbed systemically. Has anyone successfully argued against this? It appears it's still fine to obtain a biowaiver for the efficacy part, but not for safety?! To me, this is a WTF moment, but maybe I'm missing out on something. Does that make sense to anyone (for a solution)?

Thank you,

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