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| Dockets Entered
On July 2, 2007
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| Docket #
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| Title
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| 2002N-0277
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| Bioterrorism; Establishment & Maintenance of Records
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| 2006D-0480
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| Guidance for Industry
on Complementary & Alternative Medicine Products & Their Regulation
by the Food and Drug Administration
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| 2006N-0525
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| Supplements and Other Changes to an Approved Application
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| 2006P-0405
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| Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions
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| 2007D-0083
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| Guidance for Industry and Food and Drug Administration Staff; Modifications to Devices Subject to Premarket Approval (PMA) Applications The PMA Supplement Decision Making Process
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| 2007D-0106
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| Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting Improving Human Subject Protection
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| 2007D-0173
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| Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| 2002N-0277
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| Bioterrorism; Establishment & Maintenance of Records
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| REF 2
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| OMB Review
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| Vol #:
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| 31
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| SUP 5
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| Sanofi-aventis US LLC
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| Vol #:
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| 8
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| 2006D-0480
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| Guidance for Industry
on Complementary & Alternative Medicine Products & Their Regulation
by the Food and Drug Administration
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| EC 638
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| Mr. greg reiser
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| Vol #:
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| 26
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| EC 639
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| Ms. Barbara Lex
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| Vol #:
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| 26
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| EC 640
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| Mr. Jeremy jacobsen
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| Vol #:
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| 26
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| EC 641
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| Mr. William Mullins
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| Vol #:
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| 26
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| EC 642
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| Ms. Catherine Wabeke
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| Vol #:
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| 26
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| EC 643
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| Mrs. Beverly Jeffries
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| Vol #:
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| 26
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| EC 644
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| Mrs. Barbara Paola
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| Vol #:
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| 26
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| EC 645
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| Mr. Martin Haak
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| Vol #:
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| 26
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| EC 646
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| Mr. Jon Hopper
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| Vol #:
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| 26
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| EC 647
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| Ms. nancy herbert
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| Vol #:
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| 26
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| EC 648
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| UniversaL Alignment
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| Vol #:
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| 26
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| EC 649
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| Mr. Phill Remick
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| Vol #:
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| 26
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| EC 650
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| Akron General Medical Center / Radiology
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| Vol #:
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| 26
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| EC 651
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| Mr. Gamal Baki
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| Vol #:
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| 26
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| EC 652
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| Voting Citizen
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| Vol #:
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| 26
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| EC 653
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| Mrs. Valerie Zitzman
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| Vol #:
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| 26
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| EC 654
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| Dr. David Gerke
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| Vol #:
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| 26
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| EC 655
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| Mrs. Yvette Correa
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| Vol #:
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| 26
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| EC 656
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| Mr. James Sullivan
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| Vol #:
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| 26
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| EC 842
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| Ms. Shelly Heit
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| Vol #:
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| 26
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| EC 843
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| Ms. Peggy Bateman
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| Vol #:
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| 26
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| EC 844
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| Dr. Erna Pagenkopf
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| Vol #:
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| 26
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| EC 845
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| Ms. Mary Ramirez
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| Vol #:
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| 26
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| EC 846
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| Mrs. Linda Burns
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| Vol #:
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| 26
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| EC 847
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| Mrs. Stephanie Staker
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| Vol #:
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| 26
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| EC 848
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| Mrs. Zoe Rowlandson
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| Vol #:
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| 26
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| EC 849
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| Mr. richard marshall
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| Vol #:
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| 26
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| EC 850
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| Ms. Gail Wilson
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| Vol #:
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| 26
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| EC 851
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| Mr. jack verbeek
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| Vol #:
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| 26
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| EC 852
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| Mr. Michael Van Straten
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| Vol #:
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| 26
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| EC 853
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| ITV Ventures
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| Vol #:
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| 26
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| EC 854
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| Mr. Daniel Nieliwocki
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| Vol #:
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| 26
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| EC 855
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| Mr. Rod Wendt
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| Vol #:
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| 26
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| EC 856
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| Ms. A. Frost
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| Vol #:
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| 26
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| EC 857
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| Ms. P L D Dube
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| Vol #:
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| 26
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| EC 858
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| Mr. William Vaughn
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| Vol #:
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| 26
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| EC 859
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| Mr. mike lima
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| Vol #:
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| 26
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| EC 860
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| Ms. sharla keith
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| Vol #:
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| 26
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| EC 861
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| Mr. Michael Eck
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| Vol #:
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| 26
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| EXT 1
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| Graceway Pharmaceuticals, LLC
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| Vol #:
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| 1
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| 2006N-0525
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| Supplements and Other Changes to an Approved Application
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| C 7
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| Vol #:
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| 1
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| C 8
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| Sepracor, Inc.
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| Vol #:
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| 1
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| 2006P-0405
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| Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions
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| C 4
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| People's Medical Society
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| Vol #:
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| 2
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| C 5
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| W. R. Rowley, MD
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| Vol #:
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| 2
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| 2007D-0083
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| Guidance for Industry and Food and Drug Administration Staff; Modifications to Devices Subject to Premarket Approval (PMA) Applications The PMA Supplement Decision Making Process
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| C 3
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| Abbott Laboratories
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| Vol #:
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| 1
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| 2007D-0106
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| Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting Improving Human Subject Protection
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| C 6
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| Washington University in St. Louis
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| Vol #:
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| 1
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| 2007D-0173
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| Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators
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