Posted On: 09/16/2015 8:42:30 AM
Post# of 72443
nice PR -- Brilacidin at ICAAC, and glad to see the update on the MTA for B (many of us had been wondering about that for some time), twd preventing infections in implants...
of late, there's been commentary on how, via new legislation, to improve the FDA's approach to Combo Products -- "drug and/or device and/or biologic and don't fit nicely into existing regulatory pathways, yet comprise roughly one-third of all products in development today."
below some reads. first the best. if B continues to perform thru Ph III, and gains approval, hopefully this door will be opened further, additional Combo applications for B and possibly the PolyCides.
http://thehill.com/blogs/pundits-blog/healthc...s-policies
http://www.mddionline.com/blog/devicetalk/how...s-08-07-15
http://www.fdalawblog.net/fda_law_blog_hyman_...ening.html
of late, there's been commentary on how, via new legislation, to improve the FDA's approach to Combo Products -- "drug and/or device and/or biologic and don't fit nicely into existing regulatory pathways, yet comprise roughly one-third of all products in development today."
below some reads. first the best. if B continues to perform thru Ph III, and gains approval, hopefully this door will be opened further, additional Combo applications for B and possibly the PolyCides.
http://thehill.com/blogs/pundits-blog/healthc...s-policies
http://www.mddionline.com/blog/devicetalk/how...s-08-07-15
http://www.fdalawblog.net/fda_law_blog_hyman_...ening.html
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