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First Final Guidance For Overhauled US OTC Monograph Program Covers Submitting Proposals

 
• By Malcolm Spicer

Publication of final guidance for industry on submitting change proposals and other requests using the only accepted format, electronic, leaves agency at four of the five required guidances it has provided on compliance with requirements of its streamlined OTC monograph process.

• Source: Shutterstock

It remains four down and one to go for guidances the US Food and Drug Administration is required to provide by the legislation authorizing its OTC monograph program overhaul as the first guidance is made final.

Publication on 23 July of the final guidance for industry on submitting change proposals and other requests using the only accepted format, electronic, doesn’t change the number of guidances...

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