Biotechnology and the LawAmerican Bar Association, 2007 - 957 pages The book is written to help lawyers faced with the challenge of identifying the legal issues and processes that must be faced by their clients in building, marketing, and protecting a biotech business. The contributors are experts in this specialized area and provide thorough, yet accessible, overviews of biotech subspecialties with an eye to practical application. A biotech legal practice involves specialized subject matter and regulatory schemes that, generally, are not part of the business lawyer's repertoire and which can present many hazards for the uninitiated. Because of the expansion in biotech practice beyond the traditional organizations and their representatives, this guide was written to help lawyers find their way through the biotech maze. |
From inside the book
Results 1-5 of 65
Page xxi
... Approval of New Animal Drugs 623 625 625 625 627 628 .... 629 629 ..... 630 631 b . Denial and Withdrawal of Approval of New Animal Drugs .......... 632 c . Post - approval Requirements .............. d . Inspection , Enforcement , and ...
... Approval of New Animal Drugs 623 625 625 625 627 628 .... 629 629 ..... 630 631 b . Denial and Withdrawal of Approval of New Animal Drugs .......... 632 c . Post - approval Requirements .............. d . Inspection , Enforcement , and ...
Page xxii
... Approval Process for Biotechnology Products in Agricultural Use ........ Dr. J. Winston Porter A. Coordinated Federal Framework ..... B. Role of the Environmental Protection Agency 646 646 647 648 ...... 661 662 ...... 664 C. Role of ...
... Approval Process for Biotechnology Products in Agricultural Use ........ Dr. J. Winston Porter A. Coordinated Federal Framework ..... B. Role of the Environmental Protection Agency 646 646 647 648 ...... 661 662 ...... 664 C. Role of ...
Page xxiii
... Approval and Post - Marketing Notification ...... 693 8 . FDA Notification ................. 694 9 . Promotion of Off - Label Use 694 10 . Exchange of Scientific Information .... 695 11 . The First Amendment . 12. Other Cases of ...
... Approval and Post - Marketing Notification ...... 693 8 . FDA Notification ................. 694 9 . Promotion of Off - Label Use 694 10 . Exchange of Scientific Information .... 695 11 . The First Amendment . 12. Other Cases of ...
Page xxxii
... approval process— and most products never achieve marketing approval . In addition , many prod- ucts also must contend with the regulations of the U.S. Department of Agri- culture , the U.S. Environmental Protection Agency , and their ...
... approval process— and most products never achieve marketing approval . In addition , many prod- ucts also must contend with the regulations of the U.S. Department of Agri- culture , the U.S. Environmental Protection Agency , and their ...
Page xliii
... USDA / APHIS biotechnology permit approval and research matters . His clients include multinational companies , research in- stitutions , development - stage companies , and individual investigators About the Contributors xliii.
... USDA / APHIS biotechnology permit approval and research matters . His clients include multinational companies , research in- stitutions , development - stage companies , and individual investigators About the Contributors xliii.
Contents
IV | 1 |
VI | 4 |
VIII | 5 |
X | 6 |
XII | 7 |
XIV | 8 |
XVI | 9 |
XVIII | 10 |
CDLXXIV | 484 |
CDLXXVI | 485 |
CDLXXVII | 486 |
CDLXXVIII | 487 |
CDLXXIX | 488 |
CDLXXX | 489 |
CDLXXXI | 490 |
CDLXXXIV | 491 |
XX | 11 |
XXIII | 12 |
XXIV | 13 |
XXV | 25 |
XXIX | 26 |
XXXI | 28 |
XXXII | 29 |
XXXIII | 30 |
XXXIV | 31 |
XXXV | 34 |
XXXVI | 35 |
XXXVII | 38 |
XXXVIII | 39 |
XXXIX | 41 |
XL | 42 |
XLI | 43 |
XLII | 45 |
XLIII | 46 |
XLIV | 49 |
XLV | 51 |
XLVI | 52 |
XLVII | 53 |
XLVIII | 57 |
XLIX | 58 |
LI | 60 |
LII | 62 |
LIII | 63 |
LIV | 64 |
LV | 66 |
LVI | 69 |
LVII | 70 |
LVIII | 72 |
LIX | 73 |
LXII | 74 |
LXIII | 75 |
LXVI | 76 |
LXVIII | 77 |
LXX | 78 |
LXXI | 79 |
LXXIII | 80 |
LXXIV | 81 |
LXXV | 82 |
LXXIX | 83 |
LXXXII | 84 |
LXXXIII | 88 |
LXXXV | 91 |
LXXXVI | 95 |
LXXXVIII | 97 |
LXXXIX | 99 |
XCI | 100 |
XCII | 105 |
XCIII | 107 |
XCIV | 108 |
XCV | 109 |
XCVI | 110 |
XCVII | 111 |
XCIX | 112 |
CI | 113 |
CIII | 114 |
CIV | 115 |
CV | 117 |
CVI | 118 |
CVIII | 119 |
CIX | 121 |
CX | 122 |
CXI | 124 |
CXII | 126 |
CXIII | 127 |
CXIV | 132 |
CXV | 139 |
CXVIII | 140 |
CXX | 141 |
CXXI | 142 |
CXXII | 143 |
CXXIV | 145 |
CXXVI | 146 |
CXXVII | 147 |
CXXVIII | 148 |
CXXIX | 149 |
CXXX | 150 |
CXXXII | 151 |
CXXXIV | 152 |
CXXXVI | 154 |
CXXXVIII | 155 |
CXLI | 156 |
CXLIII | 158 |
CXLV | 160 |
CXLVII | 161 |
CXLVIII | 162 |
CXLIX | 168 |
CL | 169 |
CLI | 170 |
CLII | 171 |
CLIV | 172 |
CLVI | 173 |
CLVII | 174 |
CLVIII | 175 |
CLXI | 176 |
CLXVIII | 177 |
CLXXII | 178 |
CLXXVIII | 179 |
CLXXXIII | 180 |
CLXXXIV | 183 |
CLXXXVI | 184 |
CLXXXVIII | 185 |
CXC | 186 |
CXCII | 187 |
CXCV | 188 |
CXCVII | 189 |
CCII | 190 |
CCIV | 191 |
CCVI | 192 |
CCIX | 193 |
CCXIII | 194 |
CCXVIII | 195 |
CCXXII | 196 |
CCXXIII | 197 |
CCXXVII | 198 |
CCXXVIII | 199 |
CCXXX | 203 |
CCXXXI | 204 |
CCXXXIII | 206 |
CCXXXIV | 209 |
CCXXXV | 210 |
CCXXXVII | 212 |
CCXXXVIII | 213 |
CCXXXIX | 214 |
CCXLI | 215 |
CCXLIII | 216 |
CCXLIV | 217 |
CCXLV | 218 |
CCXLVII | 219 |
CCXLIX | 220 |
CCL | 221 |
CCLII | 222 |
CCLIV | 223 |
CCLVII | 224 |
CCLIX | 225 |
CCLXI | 226 |
CCLXIII | 227 |
CCLXIV | 228 |
CCLXVII | 230 |
CCLXIX | 231 |
CCLXX | 232 |
CCLXXII | 233 |
CCLXXIII | 234 |
CCLXXV | 235 |
CCLXXVII | 236 |
CCLXXVIII | 237 |
CCLXXIX | 239 |
CCLXXXI | 240 |
CCLXXXII | 241 |
CCLXXXIV | 253 |
CCLXXXV | 265 |
CCLXXXVI | 266 |
CCLXXXVII | 267 |
CCLXXXVIII | 268 |
CCLXXXIX | 270 |
CCXC | 271 |
CCXCI | 272 |
CCXCIII | 273 |
CCXCV | 274 |
CCXCVIII | 275 |
CCCII | 276 |
CCCIV | 277 |
CCCVII | 281 |
CCCX | 282 |
CCCXIII | 283 |
CCCXIV | 285 |
CCCXVI | 286 |
CCCXVII | 287 |
CCCXX | 288 |
CCCXXIII | 289 |
CCCXXVII | 290 |
CCCXXIX | 291 |
CCCXXXI | 299 |
CCCXXXIII | 300 |
CCCXXXIV | 301 |
CCCXXXVII | 302 |
CCCXXXIX | 303 |
CCCXLII | 304 |
CCCXLIV | 305 |
CCCXLVI | 307 |
CCCXLVII | 308 |
CCCXLVIII | 309 |
CCCXLIX | 310 |
CCCL | 312 |
CCCLII | 314 |
CCCLIV | 315 |
CCCLV | 318 |
CCCLVI | 325 |
CCCLVII | 326 |
CCCLVIII | 327 |
CCCLIX | 328 |
CCCLX | 330 |
CCCLXII | 331 |
CCCLXIV | 332 |
CCCLXVI | 337 |
CCCLXVII | 340 |
CCCLXVIII | 342 |
CCCLXIX | 344 |
CCCLXXI | 345 |
CCCLXXII | 346 |
CCCLXXIII | 347 |
CCCLXXIV | 348 |
CCCLXXVI | 349 |
CCCLXXVIII | 350 |
CCCLXXIX | 351 |
CCCLXXXI | 352 |
CCCLXXXIV | 353 |
CCCLXXXVII | 354 |
CCCLXXXIX | 356 |
CCCXC | 358 |
CCCXCI | 407 |
CCCXCII | 408 |
CCCXCV | 411 |
CCCXCVI | 412 |
CCCXCVII | 415 |
CCCXCVIII | 417 |
CCCXCIX | 418 |
CD | 419 |
CDI | 420 |
CDII | 421 |
CDIII | 422 |
CDIV | 423 |
CDV | 424 |
CDVIII | 425 |
CDIX | 433 |
CDX | 434 |
CDXII | 438 |
CDXIII | 439 |
CDXIV | 441 |
CDXV | 442 |
CDXVII | 445 |
CDXVIII | 446 |
CDXIX | 449 |
CDXX | 450 |
CDXXI | 451 |
CDXXII | 452 |
CDXXIII | 453 |
CDXXV | 454 |
CDXXVI | 455 |
CDXXVII | 456 |
CDXXXI | 457 |
CDXXXIV | 458 |
CDXXXVII | 459 |
CDXXXIX | 460 |
CDXLII | 461 |
CDXLIV | 462 |
CDXLVI | 463 |
CDXLIX | 464 |
CDLI | 465 |
CDLIII | 469 |
CDLVI | 470 |
CDLVIII | 471 |
CDLIX | 472 |
CDLXI | 475 |
CDLXIV | 476 |
CDLXVII | 477 |
CDLXVIII | 479 |
CDLXIX | 480 |
CDLXX | 481 |
CDLXXIII | 483 |
CDLXXXVI | 493 |
CDLXXXVII | 494 |
CDLXXXVIII | 495 |
CDLXXXIX | 497 |
CDXCI | 498 |
CDXCII | 499 |
CDXCIV | 500 |
CDXCVII | 501 |
CDXCVIII | 509 |
CDXCIX | 512 |
DI | 518 |
DII | 519 |
DIII | 521 |
DV | 523 |
DVI | 524 |
DVII | 525 |
DVIII | 526 |
DIX | 528 |
DXII | 529 |
DXV | 530 |
DXVII | 531 |
DXVIII | 532 |
DXIX | 534 |
DXXI | 536 |
DXXIII | 537 |
DXXIV | 539 |
DXXVIII | 542 |
DXXIX | 543 |
DXXX | 544 |
DXXXI | 545 |
DXXXII | 546 |
DXXXIII | 547 |
DXXXV | 549 |
DXXXVII | 550 |
DXXXVIII | 551 |
DXL | 552 |
DXLI | 553 |
DXLIII | 554 |
DXLVIII | 555 |
DL | 563 |
DLI | 564 |
DLIII | 565 |
DLV | 566 |
DLVI | 567 |
DLVIII | 568 |
DLIX | 569 |
DLX | 571 |
DLXI | 574 |
DLXIII | 576 |
DLXIV | 578 |
DLXV | 579 |
DLXVII | 580 |
DLXIX | 581 |
DLXXI | 582 |
DLXXII | 583 |
DLXXIII | 586 |
DLXXV | 587 |
DLXXVI | 588 |
DLXXVII | 591 |
DLXXVIII | 592 |
DLXXIX | 593 |
DLXXXI | 595 |
DLXXXIII | 596 |
DLXXXIV | 597 |
DLXXXV | 600 |
DLXXXVII | 602 |
DLXXXIX | 603 |
DXC | 605 |
DXCII | 607 |
DXCIII | 608 |
DXCIV | 609 |
DXCV | 610 |
DXCVIII | 612 |
DXCIX | 614 |
DC | 615 |
DCI | 623 |
DCII | 625 |
DCIII | 627 |
DCIV | 628 |
DCV | 629 |
DCVI | 630 |
DCVII | 631 |
DCVIII | 632 |
DCXI | 633 |
DCXIII | 635 |
DCXIV | 636 |
DCXV | 637 |
DCXVI | 639 |
DCXVII | 641 |
DCXVIII | 642 |
DCXX | 643 |
DCXXI | 644 |
DCXXIV | 645 |
DCXXVII | 646 |
DCXXIX | 647 |
DCXXX | 648 |
DCXXXI | 661 |
DCXXXII | 662 |
DCXXXIII | 664 |
DCXXXIV | 666 |
DCXXXV | 668 |
DCXXXVI | 670 |
DCXXXIX | 671 |
DCXLI | 672 |
DCXLIII | 673 |
DCXLIV | 674 |
DCXLV | 677 |
DCXLVI | 679 |
DCXLVIII | 680 |
DCXLIX | 682 |
DCL | 683 |
DCLII | 684 |
DCLIII | 686 |
DCLV | 687 |
DCLVI | 691 |
DCLX | 692 |
DCLXI | 693 |
DCLXII | 694 |
DCLXIV | 695 |
DCLXV | 696 |
DCLXVI | 699 |
DCLXVIII | 700 |
DCLXIX | 701 |
DCLXXI | 707 |
DCLXXII | 708 |
DCLXXIV | 709 |
DCLXXV | 710 |
DCLXXIX | 711 |
DCLXXXI | 712 |
DCLXXXIV | 713 |
DCLXXXV | 714 |
DCLXXXVI | 715 |
DCLXXXVII | 716 |
DCLXXXIX | 718 |
DCXC | 721 |
DCXCI | 722 |
DCXCII | 723 |
DCXCIV | 724 |
DCXCVII | 725 |
DCXCVIII | 726 |
DCXCIX | 728 |
DCCI | 729 |
DCCIII | 730 |
DCCV | 731 |
DCCVI | 732 |
DCCVII | 733 |
DCCVIII | 735 |
DCCXIII | 737 |
DCCXIV | 739 |
DCCXVI | 740 |
DCCXVII | 741 |
DCCXVIII | 742 |
DCCXXI | 743 |
DCCXXIII | 744 |
DCCXXIV | 745 |
DCCXXVI | 746 |
DCCXXVIII | 747 |
DCCXXIX | 748 |
DCCXXX | 749 |
DCCXXXI | 750 |
DCCXXXIII | 751 |
DCCXXXV | 753 |
DCCXXXVII | 755 |
DCCXXXVIII | 756 |
DCCXL | 757 |
DCCXLII | 758 |
DCCXLIII | 759 |
DCCXLIV | 761 |
DCCXLV | 762 |
DCCXLVI | 763 |
DCCXLVIII | 764 |
DCCLI | 765 |
DCCLII | 766 |
DCCLIII | 767 |
DCCLVI | 768 |
DCCLVII | 769 |
DCCLX | 771 |
DCCLXII | 772 |
DCCLXIII | 773 |
DCCLXV | 774 |
DCCLXVI | 775 |
DCCLXVII | 776 |
DCCLXIX | 777 |
DCCLXXI | 779 |
DCCLXXII | 780 |
DCCLXXIV | 781 |
DCCLXXVI | 782 |
DCCLXXIX | 783 |
DCCLXXXII | 784 |
DCCLXXXIII | 785 |
DCCLXXXIV | 786 |
DCCLXXXV | 787 |
DCCLXXXVI | 788 |
DCCLXXXIX | 789 |
DCCXC | 790 |
DCCXCI | 791 |
DCCXCIII | 792 |
DCCXCV | 793 |
DCCXCVIII | 794 |
DCCXCIX | 795 |
DCCCI | 796 |
DCCCV | 797 |
DCCCVI | 798 |
DCCCVIII | 813 |
DCCCIX | 815 |
DCCCX | 816 |
DCCCXII | 817 |
DCCCXIII | 818 |
DCCCXIV | 819 |
DCCCXVII | 821 |
DCCCXVIII | 822 |
DCCCXIX | 824 |
DCCCXX | 825 |
DCCCXXI | 826 |
DCCCXXII | 828 |
DCCCXXIII | 829 |
DCCCXXIV | 830 |
DCCCXXV | 831 |
DCCCXXVI | 833 |
DCCCXXVII | 834 |
DCCCXXVIII | 835 |
DCCCXXIX | 836 |
DCCCXXXI | 837 |
DCCCXXXII | 838 |
DCCCXXXIII | 840 |
DCCCXXXIV | 841 |
DCCCXXXV | 843 |
DCCCXXXVII | 857 |
DCCCXXXVIII | 858 |
DCCCXXXIX | 859 |
DCCCXLII | 863 |
DCCCXLIV | 864 |
DCCCXLV | 865 |
DCCCXLVI | 866 |
DCCCXLVII | 867 |
DCCCXLVIII | 868 |
DCCCL | 869 |
DCCCLI | 870 |
DCCCLIII | 871 |
DCCCLV | 872 |
DCCCLVI | 873 |
DCCCLVIII | 874 |
DCCCLX | 875 |
DCCCLXI | 880 |
DCCCLXIV | 881 |
DCCCLXVII | 882 |
DCCCLXX | 883 |
DCCCLXXI | 884 |
DCCCLXXIII | 885 |
DCCCLXXIV | 886 |
DCCCLXXVI | 887 |
DCCCLXXVII | 888 |
DCCCLXXVIII | 893 |
DCCCLXXIX | 894 |
DCCCLXXX | 896 |
DCCCLXXXI | 900 |
DCCCLXXXIII | 912 |
DCCCLXXXIV | 918 |
DCCCLXXXVI | 923 |
DCCCLXXXVII | 933 |
935 | |
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Common terms and phrases
addition agency agreement amended animal drugs approval authorization Bayh-Dole Act biological product biotech company biotechnology biotechnology company cell chapter claims clinical trials collaboration commercial company's compliance conduct confidentiality contract contractor Covered Entity disclose disclosure documents employee ensure European European Commission European Medicines Agency exemption FDA's federal filing founders funding genetic GMOs grant Guidance hazardous waste HIPAA human IACUC individual infringement Initial Public Offering intellectual property invention investigational investors issues license licensor limited litigation manufacturing medical devices Medicare medicinal products ment option organization parties partner patent application payment pharmaceutical pharmacovigilance potential Practice Points preclinical research prior art Privacy procedures protection registration regulations regulatory requirements risk royalty safety shares specific sponsor tion trade secret trademark VSTA