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2020-07-22
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Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Draft Guidance for Industry; Availability
Notices
D09002ee1bdb4ed4e
D09002ee1bdb4edff
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.'' This draft guidance outlines FDA's current thinking on several topics relevant to the development of cannabis and cannabis- derived products: The source of cannabis and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 This draft guidance has been developed to help support clinical research into development of cannabis and cannabis-derived products.
85 FR 44305
https://www.govinfo.gov/app/details/FR-2020-07-22/2020-15907
2020-15907
fr22jy20-69
4164-01-P
Docket No. FDA-2020-D-1079
https://www.govinfo.gov/app/details/FR-2020-07-22/2020-15907
https://www.govinfo.gov/content/pkg/FR-2020-07-22/html/2020-15907.htm
https://www.govinfo.gov/content/pkg/FR-2020-07-22/pdf/2020-15907.pdf
3 p.
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85 FR 44305
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Draft Guidance for Industry; Availability; Federal Register Vol. 85, Issue
NOTICE
2020-15907
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2020-09-21
Docket No. FDA-2020-D-1079
4164-01-P
2020-15907
Notice of 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.'' This draft guidance outlines FDA's current thinking on several topics relevant to the development of cannabis and cannabis- derived products: The source of cannabis and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.
Submit either electronic or written comments on the draft guidance by September 21, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Amy Muhlberg, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 51, Rm. 3117, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402- 6901 or Cassandra Taylor, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 51, Rm. 4150, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-5290.
Guidance:
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research,
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs
https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/scientific-data-and-information-about-products-containing-cannabis-or-cannabis-derived-compounds
https://www.fda.gov/news-events/public-health-focus/fda-and-cannabis-research-and-drug-approval-process
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 85, no. 141
Office of the Federal Register, National Archives and Records Administration
2020-07-22
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317 p.
Table of Contents:
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AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2020-07-22
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https://www.govinfo.gov/content/pkg/FR-2020-07-22/pdf/FR-2020-07-22.pdf
https://www.govinfo.gov/content/pkg/FR-2020-07-22/xml/FR-2020-07-22.xml
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2020-07-22
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FR-2020-07-22
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