Authorities Cited: Code of Federal Regulations 21 C.F.R. § 201.57(c)(1) Supreme Court 477 U.S. 317, 322 Circuit Courts 929 F.2d 1094, 1099 949 F.2d 806, 812 953 F.2d 909, 912 130 F.3d 657, 659 165 F.3d 374 183 F.3d 464, 467-468 209 F.3d 772, 776 264 F.3d 493 423 F.3d 460, 465 451 F.3d 339, 344 462 F.3d 364, 367-373 Federal Rules of Civil Procedure Fed. R. Civ. P. 56(c) 77 F. Supp. 2d 804, 809 115 F. Supp. 2d 732, 741 392 F. Supp. 2d 907, 921 435 F. Supp. 2d 551, 556-557 955 F. Supp. 700, 709-710