investigational/experimental therapy
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Introduction
Medical therapy in experimental/investigational stage.
Notes
- On June 2, 2016, the FDA released a new form for clinicians to request expanded access to investigational treatments for individual patients with serious or life-threatening illness that require treatment beyond currently approved therapies[1]
More general terms
More specific terms
- investigational therapies for treatment of Alzheimer's disease
- investigational treatment of Parkinson's disease
- ultrasound/microbubble therapy
References
- ↑ 1.0 1.1 FDA Statement. June 2, 2016 Statement from FDA Commissioner Robert Califf, M.D. on the release of the final individual patient expanded access form. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm504579.htm
- ↑ Charging for Investigational Drugs Under an IND. Questions and Answers. Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) June 2016 http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm351264.pdf