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FDA clarifies evidence and knowledge requirements in intended use final rule

USA - August 26 2021 On August 2, 2021, the U.S. Food and Drug Administration (“FDA”) published a final rule amending existing regulations (21 C.F.R. § 201.128 and 21 CFR…

John D. Kendzior, Sung W. Park

Marketers Beware: As COVID-19 cases increase, FDA, FTC increase efforts to crack down on fraudulent and deceptive marketing and sales of purported ‘Virus Cures’

USA - December 1 2020 The Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) have been fighting fraudulent and deceptive advertising of health…

Alison H. Peters

Trump drug pricing executive orders leave major questions unanswered

USA - August 3 2020 On July 24, 2020, President Trump signed four executive orders relating to drug pricing. These relate to the following four areas: Finalizing the…

Robert J. Hill, Andrew Lu, Joseph W. Metro, Sung W. Park, Janine Tougas

New COVID-19 “CARES Act”: Funding and Flexibilities to Support Health Care System Response to Coronavirus

USA - April 2 2020 President Trump has signed into law the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act or Act),1 sweeping legislation intended to…

Jamie Knauer, Nicole J. Aiken-Shaban, Scot T. Hasselman, Robert J. Hill, John D. Kendzior, Julia Krebs-Markrich, Carol Colborn Loepere, Arielle Lusardi, Debra A. McCurdy, Rahul Narula, Sonia Nguyen, Sung W. Park, Ryan M. Pate, Paul W. Pitts, James Segroves

FDA’s Section 804 Prescription Drug Importation Program and 801(d)(1)(B) Guidance

Canada, USA - January 14 2020 On December 23, 2019, the U.S. Food and Drug Administration (FDA) published in the Federal Register a set of proposed rules covering the requirements…

Catherine E. David, Sung W. Park