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Section 312.81 - Scope

1 Citing brief

  1. Bausch & Lomb Incorporated v. Mimetogen Pharmaceuticals Inc.

    Cross MOTION for Summary Judgment and to MOTION Strike Certain Exhibits to Mimetogen's Appendix to its L.R. 56 Statement of Undisputed Facts

    Filed September 22, 2016

    impact… survival, day to day functionality, or likelihood that if left untreated progress to more serious one” [21 CFR312.300(b)(1)]. Life threatening as defined in 21 CFR 312.81(a) would also be serious. Consistent with accelerated approval, fast track designation, expanded access of investigational drugs for treatment use.