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| Dockets Entered
On May 18, 2007
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| Docket #
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| Title
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| 1999V-0190
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| Variance Laser Light Show LSD110XL MRAK10 & MRAK250
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| 2004D-0193
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| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
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| 2004E-0398
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| Patent Extension for IRESSA (gefitinib), U.S. Patent No. 5,770,599
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| 2005D-0468
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays
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| 2005E-0248
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| Patent Term Extension Application for Fosrenol, U.S. Patent No. 5,968,976
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| 2006D-0079
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| Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables
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| 2006D-0172
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| Guidance for Clinical Investigators, Institutional Review Boards and Sponsors Process for Handling Referrals to FDA Under 21 CFR 50.54 : Additional Safeguards for Children in Clinical Investigations
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| 2006D-0301
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| Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs Waivers and Reductions
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| 2006D-0303
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| Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
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| 2006D-0451
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| Guidance for Industry, Food and Drug Administration Staff, Eye Care Professionals, and Consumers
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| 2006D-0514
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| Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
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| 2006D-0515
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays
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| 2006E-0259
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| Patent Extension Application for X-STOP Interspinous Process Decompression System, U.S. Patent No. 6,235,030
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| 2006E-0501
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| Patent Extension Application for Gardasil (Quadravalent Human Papillomavirus Recombinant Vaccine), U.S. Patent No. 5,820,870
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| 2006E-0502
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| Patent Extension Application for Prezista (darunavir ethanolate), U.S. Patent No. 6,248,775
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| 2006N-0292
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| Unique Device Identification
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2007D-0166
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| Draft Guidance for Industry on Target Animal Safety for Veterinary Pharmaceutical Products, VICH GL-43
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| 2007E-0046
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| Patent Extension Application for ZILMAX (zilpaterol hydrochloride), U.S. Patent No. 4,900,735
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| 2007P-0203
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| Abbreviated New Drug Application (ANDA) Suitability for Memantine Hydrochloride Orally Disintegrating Tablets 5 mg and 10 mg
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| 1999V-0190
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| Variance Laser Light Show LSD110XL MRAK10 & MRAK250
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| VRA 4
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| FDA/CDRH to Artistic Laser Productions
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| Vol #:
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| 1
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| EREG 1
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| L. Stone
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| Vol #:
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| 95
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| EREG 2
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| E. Joiner
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| Vol #:
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| 95
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| EREG 3
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| A. Lesch
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| Vol #:
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| 95
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| EC 20
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| Mr. s westbrooks
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| Vol #:
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| 2
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| EC 21
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| none
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| Vol #:
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| 2
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| 2004D-0193
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| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
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| EC 8
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| BSN, RN (retired)
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| Vol #:
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| 1
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| | | | | | | | |
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| 2004E-0398
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| Patent Extension for IRESSA (gefitinib), U.S. Patent No. 5,770,599
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| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2005D-0468
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays
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| EC 4
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| Ms. charisse texeira
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| Vol #:
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| 1
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| 2005E-0248
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| Patent Term Extension Application for Fosrenol, U.S. Patent No. 5,968,976
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| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006D-0079
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| Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables
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| EC 6
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| Ms. Elizabeth Greene
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| Vol #:
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| 1
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| EC 7
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| Mr. Ken Youngblood
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| Vol #:
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| 1
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| EC 8
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| Miss. L Franke
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| Vol #:
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| 1
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| EC 9
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| none
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| Vol #:
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| 1
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| EC 10
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| Ms. Kim Eyring
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| Vol #:
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| 1
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| EC 11
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| Mr. Michael Damato
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| Vol #:
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| 1
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| EC 12
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| Mr. Matt Ballotti
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| Vol #:
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| 1
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| EC 13
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| Mr. GW Seals
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| Vol #:
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| 1
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| EC 14
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| logical parent
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| Vol #:
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| 1
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| EC 15
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| Mrs. Elizabeth Zirkle
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| Vol #:
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| 1
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| EC 16
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| Mrs. SHELLIE BELL
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| Vol #:
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| 1
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| EC 17
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| College Of The Siskiyous
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| Vol #:
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| 1
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| EC 18
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| Mr. Michael Sertich
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| Vol #:
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| 1
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| EC 19
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| Mr. JD Cogmon
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| Vol #:
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| 1
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| EC 20
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| Mr. Escott Moss
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| Vol #:
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| 1
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| EC 21
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| Mr. Andrew Houlihan
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| Vol #:
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| 1
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| EC 22
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| Ms. Jennifer Bothell
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| Vol #:
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| 1
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| EC 23
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| Mr. Joseph Dobrozsi
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| Vol #:
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| 1
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| EC 24
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| Ms. Elizabeth Shaw
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| Vol #:
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| 1
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| EC 25
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| Ms. Valerie Berg
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| Vol #:
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| 1
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| EC 26
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| Mr. Gordon Kress
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| Vol #:
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| 1
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| EC 27
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| Miss. Stephanie Jovani
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| Vol #:
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| 1
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| EC 28
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| Miss. jane m
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| Vol #:
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| 1
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| EC 29
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| Dr. Kirby Ram
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| Vol #:
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| 1
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| EC 30
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| Mr. roy stubbs
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| Vol #:
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| 1
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| EC 31
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| Mr. Charles Larkin
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| Vol #:
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| 1
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| EC 32
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| Mr. Mike Jones
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| Vol #:
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| 1
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| EC 33
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| Mr. phillip lee
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| Vol #:
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| 1
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| EC 34
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| Mr. VICTOR RODRIGUEZ
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| Vol #:
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| 1
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| EC 35
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| American
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| Vol #:
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| 1
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| EC 36
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| Mr. Aaron Acker
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| Vol #:
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| 1
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| EC 37
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| Mr. Arsalan Pourmand
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| Vol #:
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| 1
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| EC 38
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| Mr. Jason Kaloudis
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| Vol #:
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| 1
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| EC 39
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| Mr. Brad Putrycus
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| Vol #:
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| 1
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| EC 40
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| Mr. Jesse Harding
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| Vol #:
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| 1
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| EC 41
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| Ms. Elaine Kyle
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| Vol #:
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| 1
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| EC 42
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| Mrs. amy murphy
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| Vol #:
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| 1
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| 2006D-0172
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| Guidance for Clinical Investigators, Institutional Review Boards and Sponsors Process for Handling Referrals to FDA Under 21 CFR 50.54 : Additional Safeguards for Children in Clinical Investigations
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| |
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| EC 3
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| Ms. charisse texeira
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| Vol #:
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| 1
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| 2006D-0301
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| Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs Waivers and Reductions
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| EC 1
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| logical parent
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| Vol #:
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| 1
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| 2006D-0303
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| Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
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| EC 16
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| Ms. Marian Puglia
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| Vol #:
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| 1
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| EC 17
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| a brand new kind of dinasaur
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| Vol #:
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| 1
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| EC 18
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| Dyco Assoc., Inc.
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| Vol #:
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| 1
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| 2006D-0451
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| Guidance for Industry, Food and Drug Administration Staff, Eye Care Professionals, and Consumers
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| EC 2
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| none
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| Vol #:
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| 1
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| EC 3
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| Ms. Janet Rininger
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| Vol #:
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| 1
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| EC 4
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| Dr. Mark Raintree
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| Vol #:
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| 1
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| EC 5
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| Ms. Carol Clayton
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| Vol #:
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| 1
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| EC 6
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| Mr. Rene Baudisch
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| Vol #:
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| 1
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| 2006D-0514
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| Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
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| EC 3
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| Biosafe SA
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| Vol #:
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| 1
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| EC 4
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| Biosafe SA
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| Vol #:
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| 1
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| EC 5
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| Cryobanks International, Inc.
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| Vol #:
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| 1
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| EC 6
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| Case Western Reserve University
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| Vol #:
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| 1
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| EC 7
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| AABB
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| Vol #:
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| 1
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| EC 8
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| AABB Interorganization Work Grop
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| Vol #:
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| 1
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| EC 9
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| Community Blood Services
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| Vol #:
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| 1
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| EC 10
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| Duke University Medical Center
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| Vol #:
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| 1
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| EC 11
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| Duke University Medical Center
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| Vol #:
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| 1
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| EC 12
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| Duke University Medical Center
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| Vol #:
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| 1
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| EC 13
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| Michigan Community Blood Centers
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| Vol #:
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| 1
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| EC 14
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| ViaCell
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| Vol #:
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| 1
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| EC 15
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| American Society for Blood and Marrow Transplantat
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| Vol #:
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| 1
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| EC 16
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| New York Blood Center
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| Vol #:
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| 1
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| EC 17
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| StemCyte International Cord Blood Center
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| Vol #:
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| 1
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| EC 18
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| StemCyte International Cord Blood Center
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| Vol #:
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| 3
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| EC 19
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| StemCyte International Cord Blood Center
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| Vol #:
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| 3
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| 2006D-0515
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays
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| EC 1
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| Brand new kind of dinasaur
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| Vol #:
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| 1
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| EC 2
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| Ms. charisse texeira
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| Vol #:
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| 1
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| 2006E-0259
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| Patent Extension Application for X-STOP Interspinous Process Decompression System, U.S. Patent No. 6,235,030
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| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0501
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| Patent Extension Application for Gardasil (Quadravalent Human Papillomavirus Recombinant Vaccine), U.S. Patent No. 5,820,870
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| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0502
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| Patent Extension Application for Prezista (darunavir ethanolate), U.S. Patent No. 6,248,775
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| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006N-0292
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| Unique Device Identification
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| C 29
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| Grandview Medical Center
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| Vol #:
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| 8
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| C 93
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| B Keslinger
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| Vol #:
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| 7
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| 2007D-0166
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| Draft Guidance for Industry on Target Animal Safety for Veterinary Pharmaceutical Products, VICH GL-43
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| GDL 1
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| Guidance
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| Vol #:
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| 1
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| NAD 1
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| FDA
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| Vol #:
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| 1
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| 2007E-0046
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| Patent Extension Application for ZILMAX (zilpaterol hydrochloride), U.S. Patent No. 4,900,735
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| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2007P-0203
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| Abbreviated New Drug Application (ANDA) Suitability for Memantine Hydrochloride Orally Disintegrating Tablets 5 mg and 10 mg
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| ACK 1
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| FDA / DDM to Orgenus Pharma, Inc.
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| Vol #:
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| 1
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| CP 1
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| Orgenus Pharma, Inc.
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| Vol #:
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| 1
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