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US OTC Monograph Reform Enters Electronic Age With Draft Guidance On Submission Formats

 
• By Malcolm Spicer

Submissions go to one of two addresses: OMORs, for changes or additions to monograph formulations and indications, go to the CDER NextGen Portal, and data, information and public comments on proposed or interim final orders go to OTC Monographs@FDA.

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Two down and three to go for industry guidances required from the US Food and Drug Administration for using the overhauled OTC monograph after publication of a draft guidance on submitting monograph change proposals and other requests in the only accepted format, electronic.

The agency’s Center for Drug Evaluation and Research on 28 September announced the draft guidance to be published in...

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