| http://www.w3.org/ns/prov#value | - Defendants have also withheld other information that is routinely released by the FDA after an NDA is approved: protocols, adverse reaction reports, product experience reports, consumer complaints, and other similar data and information, and allcorrespondence and written summaries of oral discussions between FDA and the applicant relating to the application. 21 C.F.R. ?? 314.430 (e)(3),(4) & (
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