Authorities Cited: United States Code 15 U.S.C. § 1114(1)(a) 15 U.S.C. § 1116(a) 15 U.S.C. § 1125(a) 15 U.S.C. § 1127 15 U.S.C. § 11277 21 U.S.C. § 301 Code of Federal Regulations 21 C.F.R. § 807.81(a)(1) 21 C.F.R. § 807.97 21 C.F.R. § 814.1(c) Supreme Court 531 U.S. 341, 345 547 U.S. 388, 126-397 Circuit Courts 675 F.2d 852, 858 756 F.2d 1535, 1543 881 F.2d 1570, 1573 889 F.2d 1018, 1029 129 F.3d 1, 2-3 140 F.3d 1175, 1180 147 F.3d 1301, 1310 174 F.3d 1036 192 F.3d 1330, 1335 222 F.3d 895, 907 261 F.3d 1188, 1194-1195 263 F.3d 359, 364 284 F.3d 302, 311 299 F.3d 1242, 1246-1250 300 F.3d 808 315 F.3d 264, 274 354 F.3d 1020 354 F.3d 1023 357 F.3d 1256, 1261 403 F.3d 672 414 F.3d 400, 404-411 430 F.3d 901, 904 497 F.3d 144, 158 765 F. Supp. 724, 734