July 2020

FDA Imposes New Yearly Charges for OTC Monograph Drug Establishment

US FDA OTC regulations /

FDA Imposes New Yearly Charges for OTC Monograph Drug Establishment   This article has been updated on the 5th of January 2021 https://cosmereg.com/fda-withdraw-the-new-otc-monograph-user-fee-for-fy-2021/   In the past March, President Trump had signed a pandemic aid act named “CARES”. This act featured a measure that reshapes and upgrades the manner specific OTC and non-prescription drugs are […]

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FDA registration requirements to import face masks

US FDA Medical Devices /

FDA registration requirements to import Face Mask Guidelines to import face mask and FDA registration Non-surgical Face mask (no EUA required)    Register as an importer, and have your manufacturer the FDA registration as a medical device manufacturing establishment with FDA. List the medical device product that you intend to import. (FDA’s fee is $5,236,

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