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Zdrowie i gospodarka · 22/07/2020

Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research." This draft guidance outlines FDA's current thinking on several topics relevant to the development of cannabis and cannabis- derived products: The source of cannabis and cannabis-derived compounds for clinical research; general quality considerations for developing drugs that contain cannabis and cannabis-derived compounds; and calculation of percent delta-9 tetrahydrocannabinol (THC) in botanical raw materials, extracts, and finished products. This draft guidance has been developed to help support clinical research into development of cannabis and cannabis-derived products.

Source: Federal Register — Food and Drug AdministrationOpen original release →