Stay Tuned For FDA OTC Monographs Portal Update

With monographs@FDA portal down, agency moves to NextGen and extends comment period through 27 September for first OTC monograph change it proposed using its overhauled program other than 32 monographs finalizations required in 2020 legislation authorizing overhaul.

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If ever a glitch in a Food and Drug Administration program could be attributed to growing pains, the Office of Nonprescription Drug’s problem with its OTC Monographs@FDA portal would be it.

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