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OTC User Fees March 28, 2020

Posted by Michael Hamrell in Uncategorized.
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During these challenging times in the middle of the Covid-19 crisis, it is important to note a major change that will be coming to FDA. One of the many ‘extra’ provisions added to the CARES Act, is the passage of User Fees for Over-the-Counter (OTC) drug products. This is something that FDA and the industry has been discussing and seeking for several years. Details are not available yet as to exactly how this will be implemented and what it will mean to the struggling Monograph process that has been in process since 1972!

More details to follow.