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investigational/experimental therapy
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]
Specific
investigational therapies for treatment of Alzheimer's disease
investigational treatment of Parkinson's disease
ultrasound/microbubble therapy
General
medical therapy; therapeutic intervention
References
- 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