Posted On: 10/22/2014 9:23:25 AM
Post# of 30015
Timing of decision for an ODD application question was asked last week....not sure if any validated answer was given. According to this FDA link, it's less than 90 days. (slide 16)
http://www.fda.gov/downloads/ForIndustry/Deve...294786.pdf
http://www.fda.gov/downloads/ForIndustry/Deve...294786.pdf
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