Posted On: 09/23/2015 11:14:03 PM
Post# of 72446
Glad to do it. The more info out there the better.
Forgot to add this other BMJ article to my last post. Goes to the path Kevetrin is likely to follow ... orphan designation for multiple conditions then eventually breakthroigh.
"Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review"
BMJ 2015; 351 doi: http://dx.doi.org/10.1136/bmj.h4679 (Published 23 September 2015)
Cite this as: BMJ 2015;351:h4679
http://www.bmj.com/content/351/bmj.h4679
Below the actual FDA guidance on Expedited Pathways.
http://www.fda.gov/downloads/drugs/guidanceco...358301.pdf
And best slide deck on Breakthrough Therapy.
http://www.fda.gov/downloads/AboutFDA/Centers...447162.pdf
Forgot to add this other BMJ article to my last post. Goes to the path Kevetrin is likely to follow ... orphan designation for multiple conditions then eventually breakthroigh.
"Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review"
BMJ 2015; 351 doi: http://dx.doi.org/10.1136/bmj.h4679 (Published 23 September 2015)
Cite this as: BMJ 2015;351:h4679
http://www.bmj.com/content/351/bmj.h4679
Below the actual FDA guidance on Expedited Pathways.
http://www.fda.gov/downloads/drugs/guidanceco...358301.pdf
And best slide deck on Breakthrough Therapy.
http://www.fda.gov/downloads/AboutFDA/Centers...447162.pdf
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