Cori Annapolen Goldberg

Reed Smith LLP

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HHS Reverses Policy on Laboratory Developed Tests (LDTs)

USA - November 17 2021 There was a meaningful update from the U.S. Department of Health and Human Services (HHS) yesterday regarding FDA’s regulation of…

Attack of the SPAC: Success of alternative IPO method hinges on due diligence

USA - May 12 2021 Special purpose acquisition companies, or SPACs, have become a widely accepted vehicle by which companies can go public rather than through a…

Ari Edelman, Sung W. Park

Sesame to become 9th Major Food Allergen

USA - April 26 2021 President Biden signed into law the FASTER Act on Friday, which adds sesame to the existing list of eight major food allergens (now nine). This…

FDA and USDA battle over regulating genetically engineered animals

USA - February 23 2021 A substantial shift for genetically engineered (“GE”) food regulation may be on the horizon thanks to a USDA proposed rule with a fast closing…

Yuxin Jin, Sung W. Park, Taber Rueter

April Warning Letter Showers: The FDA Issues Over Twenty Warning Letters to Companies Making Fraudulent Coronavirus Claims

USA - May 8 2020 Last month, the U.S. Food and Drug Administration (“FDA”) issued over twenty Warning Letters to companies located in both the United States and…

Erika Auger