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Regulatory Focus™ > News Articles > Quality & Compliance: An NDA for Water

Quality & Compliance: An NDA for Water

Posted 01 February 2008

This is a case study about the requirement of a New Drug Application (NDA) for water as the active pharmaceutical ingredient (API) of an eyewash product. It is an ongoing case, representing an unforeseen glitch in the regulations. Most of the information is public but I will not name the company.

 

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