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FDA Says It Supports Cannabis Drug Development via Regulatory Pathways

FDA Says It Supports Cannabis Drug Development via Regulatory Pathways News & Analysis News From the Food and Drug Administration FDA Says It Supports Cannabis Drug receptor α. The mutation is rare. According mutation, the overall response rate was Development via Regulatory Pathways to the drug’s manufacturer, Blueprint Medi- 89%—8% with a complete response and A key FDA official told members of Con- cines Corporation in Cambridge, Massachu- 82% with a partial response. gress last month that the agency supports setts, about 6% of patients with a newly Common adverse reactions to the drug the development of new drugs that con- diagnosed GIST harbor this mutation. An include cognitive impairment, dizziness, tain cannabis or are derived from the plant. estimated 4000 to 6000 US adults are sleep or mood disorders, and hallucina- Speaking before the House Committee diagnosed with a GIST annually. tions. Avapritinib has also been associated on Energy and Commerce, Douglas with intracranial hemorrhage. Throckmorton, MD, deputy director for regulatory programs at the FDA’s Center for FDA Assesses Potential Cancer Risk Drug Evaluation and Research, said investi- Associated With Weight Loss Drug A recent drug safety communication alerted gators interested in conducting cannabis re- search that could lead to a drug approval health professionals and the public http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

FDA Says It Supports Cannabis Drug Development via Regulatory Pathways

JAMA , Volume 323 (7) – Feb 18, 2020

FDA Says It Supports Cannabis Drug Development via Regulatory Pathways

Abstract

News & Analysis News From the Food and Drug Administration FDA Says It Supports Cannabis Drug receptor α. The mutation is rare. According mutation, the overall response rate was Development via Regulatory Pathways to the drug’s manufacturer, Blueprint Medi- 89%—8% with a complete response and A key FDA official told members of Con- cines Corporation in Cambridge, Massachu- 82% with a partial response. gress last month that the agency supports setts, about 6% of patients...
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Publisher
American Medical Association
Copyright
Copyright 2020 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2020.0833
Publisher site
See Article on Publisher Site

Abstract

News & Analysis News From the Food and Drug Administration FDA Says It Supports Cannabis Drug receptor α. The mutation is rare. According mutation, the overall response rate was Development via Regulatory Pathways to the drug’s manufacturer, Blueprint Medi- 89%—8% with a complete response and A key FDA official told members of Con- cines Corporation in Cambridge, Massachu- 82% with a partial response. gress last month that the agency supports setts, about 6% of patients with a newly Common adverse reactions to the drug the development of new drugs that con- diagnosed GIST harbor this mutation. An include cognitive impairment, dizziness, tain cannabis or are derived from the plant. estimated 4000 to 6000 US adults are sleep or mood disorders, and hallucina- Speaking before the House Committee diagnosed with a GIST annually. tions. Avapritinib has also been associated on Energy and Commerce, Douglas with intracranial hemorrhage. Throckmorton, MD, deputy director for regulatory programs at the FDA’s Center for FDA Assesses Potential Cancer Risk Drug Evaluation and Research, said investi- Associated With Weight Loss Drug A recent drug safety communication alerted gators interested in conducting cannabis re- search that could lead to a drug approval health professionals and the public

Journal

JAMAAmerican Medical Association

Published: Feb 18, 2020

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