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On September 20, 2021, the Food and Drug Administration (FDA) announced that as part of the Over-the-Counter (OTC) Monograph Reform under the Coronavirus Aid, Relief, and Economic...
To embed, copy and paste the code into your website or blog: On January 27, 2021, the Food and Drug Administration held its second webinar since the enactment of the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) in March 2020, to further discuss over-the-counter (OTC) Monograph Reform and provide guidance on the Administrative Order process, with a particular emphasis on “safety orders.” 1 Prior to the CARES Act, FDA had to engage in a multi-step public rulemaking process in order to establish or revise an OTC drug monograph. This process was not only burdensome bu...