{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.\" This draft guidance outlines FDA's current thinking on several topics relevant to the development of cannabis and cannabis- derived products: The source of cannabis and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 This draft guidance has been developed to help support clinical research into development of cannabis and cannabis-derived products.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2020/07/22/2020-15907.html","cfr_references":[],"citation":"85 FR 44305","comment_url":null,"comments_close_on":"2020-09-21","correction_of":null,"corrections":[],"dates":"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either electronic or written comments on the draft guidance by September 21, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-D-1079"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":94,"comment_start_date":"2020-07-22","updated_at":"2023-02-28T22:52:17.719-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-D-1079-0001","allow_late_comments":null,"id":"FDA-2020-D-1079-0001","comment_end_date":"2020-09-22","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2020-D-1079","title":"Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Draft Guidance for Industry; Availability "}],"document_number":"2020-15907","effective_on":null,"end_page":44307,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/07/22/2020-15907.xml","html_url":"https://www.federalregister.gov/documents/2020/07/22/2020-15907/cannabis-and-cannabis-derived-compounds-quality-considerations-for-clinical-research-draft-guidance","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-15907?publication_date=2020-07-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-07-22/2020-15907/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":3271,"last_updated":"2026-07-27 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-07-22/pdf/2020-15907.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-15907.pdf?1595335550","publication_date":"2020-07-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/07/22/2020-15907.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":94,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2020-D-1079","supporting_documents_count":0,"docket_id":"FDA-2020-D-1079","document_id":"FDA-2020-D-1079-0001","regulation_id_number":null,"title":"Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Draft Guidance for Industry; Availability ","checked_regulationsdotgov_at":"2023-03-01T03:52:16Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":44305,"subtype":null,"title":"Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Draft Guidance for Industry; Availability","toc_doc":"Cannabis and Cannabis-Derived Compounds:  Quality Considerations for Clinical Research","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":85}