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FDA has stated the guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying...
David Rosen
Partner, Foley and Lardner LLP
Washigton, DC, United States
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On August 10, 2023, the U.S. Food & Drug Administration (FDA) published new guidance on obtaining data on underrepresented populations in...
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Cosmetic companies are required to submit facility registration and product listing information on cosmetic products that they...
FDA has recently revised Form 356h: Application to Market a New or Abbreviated New Drug or Biologic for Human Use and Form 1571:...
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FDA is holding a two-day virtual public workshop to enhance clinical study diversity. This workshop is being held on November 29 and 30,...