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FDA Issues Guidance on Clinical Research with Cannabis

By Lee H. Rosebush, Randal M. Shaheen, Winston S. Kirton & Laura Macherelli on January 27, 2023
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On Jan. 23, the Food and Drug Administration (FDA) finalized industry guidance for clinical research using cannabis and cannabis-derived compounds, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. The need for the guidance stemmed from the 2018 Farm Bill, which legalized the production and sale of hemp (cannabis below 0.3 percent delta-9 THC by dry weight) and removed it from the Schedule I substance list.

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Photo of Lee H. Rosebush Lee H. Rosebush
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Photo of Randal M. Shaheen Randal M. Shaheen
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Photo of Winston S. Kirton Winston S. Kirton
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Photo of Laura Macherelli Laura Macherelli
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  • Posted in:
    Food, Drug & Agriculture
  • Blog:
    Health Law Update
  • Organization:
    Baker & Hostetler LLP
  • Article: View Original Source

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