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stringofpearls

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stringofpearls

Re: None

Monday, 04/21/2014 8:36:16 AM

Monday, April 21, 2014 8:36:16 AM

Post# of 212519

Drugs approved under 505(b)(2), on the other hand, can rely in part on data from existing reference drugs. This means they can be developed and achieve FDA approval in as little as 30 months with only a fraction of the number of required clinical trials and at much lower cost.



link:

http://www.dddmag.com/articles/2012/08/taking-505b2-route

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