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White v. Stryker Corp., Civil Action No. 3:10–CV–544–H.
- United States
- U.S. District Court — Western District of Kentucky
- March 25, 2011
...U.S.C. § 360e(c). The FDA then reviews the submission to determine whether it is sufficiently complete to enable a substantive review. 21 C.F.R. § 814.42. If so, the FDA begins its own review, which may involve referring the application to an advisory committee. See 21 C.F.R. § 814.44. Inde......