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Investigational New Drug Application (IND) Cannabis Products

BakerHostetler

FDA Issues Guidance on Clinical Research with Cannabis

BakerHostetler on

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...more

McDermott Will & Emery

FDA Issues Long-Awaited Draft Guidance on Cannabis Research

On July 21, 2020, the US Food and Drug Administration (FDA) issued a long-awaited draft guidance, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry,” which...more

Epstein Becker & Green

FDA Issues Draft Guidance on Cannabis Clinical Research and Sends CBD Enforcement Discretion Guidance to OMB for Review

Epstein Becker & Green on

FDA took two important steps last week to clarify the regulatory landscape for cannabis products, including CBD products. First, FDA issued a draft guidance on Quality Considerations for Clinical Research Involving Cannabis...more

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