FDA BRIEF: Week of April 25, 2016

marijuana.JPG

 

CENTRAL MESSAGES

  •  FDA supports scientific and rigorous assessment of marijuana
  • Current information on safety, efficacy and reliability is not good enough
  • FDA will support needed scientific research to characterize therapeutic promise

FDA HAS MULTIPLE ONGOING ACTIVITIES

  • Providing scientific advice on risks
  • Supporting rigorous scientific research into therapeutic value
  • Taking appropriate actions related to the marketing of products

FDA WILL CONTINUE TO SUPPORT DEVELOPMENT

  • Specific new drugs that are safe, effective, and manufactured to a high quality
  • Grounded in rigorous scientific research  to determine appropriate use
  • Efficient processes to speed availability to American public

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reagen-Udall

  • Creation of an EXPANDED ACCESS (EA) NAVIGATOR to provide information on the request process for individual patient access to investigational drugs, where no Expanded Access Program (EAP) has been established
  • The proposal describes the Navigator scope, functions and anticipated outcomes.
  • Navigator will provide educational content : individual patient access to drugs and biologics, FDA, IRB, manufacturer roles, information for healthcare providers, how EA fits into the drug development, clinical trial, and FDA approval processes

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