FDA BRIEF: Week of April 25, 2016
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
- 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