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The estate planning world certainly saw its share of turbulence from 2020-2022. With two significant elections, it is hard to remember a previous time with such substantial uncertainty...
The United States Environmental Protection Agency (“EPA”) issued a Final Administrative Order (“Order”) to McCann Resources, Inc. (“MRI”) for alleged violations of the Safe Drinking...
By now, businesses operating in the over-the-counter (OTC) drug product space should all be familiar with the changes made by Congress to the regulatory system with the final OTC Monograph reform bill...
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...