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After the Public Health Emergency: FDA plans to revise COVID-19 EUA policies

European Union, USA - March 28 2023 On March 10, 2023, the U.S. Food and Drug Administration (FDA) issued a Notice summarizing which of the agency’s COVID-19-related guidance documents…

Eman Al-Hassan, Robert Church, Mike Druckman, Lowell Zeta

O.K. Corral: FDA sets stage to appeal California Stem Cell Treatment Center decision

USA - January 19 2023 Last year, a federal court in California ruled against the U.S. Food and Drug Administration (FDA) in a matter where the government alleged that a…

Mike Druckman, Ashley Grey

Seeking harmony: FDA to align its human subject research regulations with Common Rule

USA - November 8 2022 Recently, the U.S. Food and Drug Administration (FDA) released two proposed rules that aim to clarify inconsistencies between FDA’s human subject…

Robert Church, William F. Ferreira, Heidi Gertner

FDA issues final guidance for importing drugs prior to anticipated approval

USA - March 8 2022 Last week, the U.S. Food and Drug Administration (FDA) published the final guidance, “Pre-Launch Activities Importation Requests (PLAIR),” describing…

David Horowitz

New FDA proposed rule will eventually preempt state drug wholesaler/3PL licensure laws

USA - February 23 2022 The U.S. Food and Drug Administration (FDA) recently announced the proposed rule, “National Standards for the Licensure of Wholesale Drug Distributors…

David Horowitz