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| Dockets Entered
On October 11, 2007
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| Docket #
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| Title
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| |
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| |
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| 2006P-0487
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| Health Claim Petition: Isomaltulose and Dental Caries
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| |
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| 2007D-0249
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| Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
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| 2007D-0252
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| Guidance for Industry and Food and Drug Administration Staff; Pulse Oximeters - Premarket Notification Submissions 510(k)s
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| 2007D-0266
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| International Conference on Harmonisation; Draft Guidance on Q10 Pharmaceutical Quality System
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| |
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| 2007D-0268
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology
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| 2007N-0262
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
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| 2007N-0321
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct
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| 2007N-0347
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| Information Technology Strategic Planning; Public Meeting
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| 2007N-0356
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| Behind The Counter Availability
of Certain Drugs; Public Meeting
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| 2007N-0389
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| Granisetron Hydrochloride Injection and 180-day generic drug exclusivity
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| 2007P-0232
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| Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release
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| 2007P-0282
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| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
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| 2007P-0295
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| Make a determination that Inderal (Propranolol Hydrochloride Tablets, 10 mg and 20 mg, NDA 016418, Product Numbers 001 and 003 respectively) held by Wyeth Pharmaceuticals, Inc., were not discontinued
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| 2007P-0297
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| Request to reconsider the failure to approve Provenge
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| 2007P-0320
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| Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
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| 2007P-0331
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| Ban Use of Mercury In Medicine,UNLESS Proven Toxicologically Safe to the CGMP Standard Sufficiently Nontoxic
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| 2007P-0333
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| Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| LET 962
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| FDA to Market America, Inc.
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| Vol #:
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| 28
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| LET 963
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| FDA to Source of Health, Inc.
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| Vol #:
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| 28
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| LET 964
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| FDA/CFSAN to Konsyl Pharmaceuticals, Inc.
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| Vol #:
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| 28
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| LET 965
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| FDA/CFSAN to Camelyn USA, Inc.
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| Vol #:
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| 28
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| LET 966
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| FDA/CFSAN to Medical Chest, Inc.
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| Vol #:
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| 28
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| LET 967
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| FDA/CFSAN to Pharmavite LLC
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| Vol #:
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| 28
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| LET 968
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| FDA/CFSAN to Market America, Inc.
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| Vol #:
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| 28
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| LET 969
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| FDA/CFSAN to Market America, Inc.
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| Vol #:
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| 28
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| C 4064
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| D. VanArsdalen
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| Vol #:
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| 35
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| C 4065
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| G. Shields
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| Vol #:
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| 35
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| C 4066
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| A. Lgnarski
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| Vol #:
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| 35
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| C 4067
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| H. Paetz
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| Vol #:
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| 35
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| C 4068
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| S. Sxhirmann
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| Vol #:
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| 35
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| C 4069
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| M. Gallman
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| Vol #:
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| 35
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| C 4070
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| W. Bowling
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| Vol #:
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| 35
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| C 4071
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| T. Berry
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| Vol #:
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| 35
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| C 4072
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| C. Coker
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| Vol #:
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| 35
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| C 4073
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| Z. Estep
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| Vol #:
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| 35
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| C 4074
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| R. Sitrin
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| Vol #:
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| 35
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| C 4075
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| A. Cabrelli
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| Vol #:
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| 35
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| C 4076
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| V. Cassidy
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| Vol #:
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| 35
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| C 4077
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| K. Anderson
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| Vol #:
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| 35
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| C 4078
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| M. Desideri
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| Vol #:
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| 35
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| C 4079
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| K. Ingber
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| Vol #:
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| 35
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| C 4080
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| C. Brecht
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| Vol #:
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| 35
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| C 4081
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| A. Fries
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| Vol #:
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| 35
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| C 4082
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| B. Freed-Lawrence
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| Vol #:
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| 35
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| C 4083
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| C. Price
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| Vol #:
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| 35
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| C 4084
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| D. Molloy
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| Vol #:
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| 35
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| C 4085
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| A. Chance
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| Vol #:
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| 35
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| C 4086
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| M. Black
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| Vol #:
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| 35
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| C 4087
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| R. Weikel
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| Vol #:
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| 35
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| C 4088
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| L. Micalizzi
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| Vol #:
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| 35
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| C 4089
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| D. Baker
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| Vol #:
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| 35
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| C 4090
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| P. O'hara
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| Vol #:
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| 35
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| 2006P-0487
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| Health Claim Petition: Isomaltulose and Dental Caries
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| EC 1
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| Ms. Lynn Steed
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| Vol #:
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| 1
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| 2007D-0249
|
| Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
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| EC 3
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| TiGenix NV
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| Vol #:
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| 1
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| EC 4
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| Ecole Polytechnique
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| Vol #:
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| 1
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| EC 5
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| Advanced Medical Technology Association
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| Vol #:
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| 1
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| EC 6
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| Ecole Polytechnique
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| Vol #:
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| 1
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| EC 7
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| Hogan
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| Vol #:
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| 1
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| EC 8
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| Genzyme Corp.
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| Vol #:
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| 1
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| EC 9
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| Regeneration Technologies, Inc.
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| Vol #:
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| 1
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| 2007D-0252
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| Guidance for Industry and Food and Drug Administration Staff; Pulse Oximeters - Premarket Notification Submissions 510(k)s
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| EC 1
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| Philips Medical Systems
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| Vol #:
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| 1
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| 2007D-0266
|
| International Conference on Harmonisation; Draft Guidance on Q10 Pharmaceutical Quality System
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| |
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| EC 2
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| Abbott Laboratories
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| Vol #:
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| 1
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| EC 3
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| the Japan Society of Pharmaceutical Machinery and
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| Vol #:
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| 2
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| EC 4
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| GlaxoSmithKline
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| Vol #:
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| 1
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| EC 5
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| Parenteral Drug Association (PDA)
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| Vol #:
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| 1
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| EC 6
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| Schering-Plough
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| Vol #:
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| 1
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| EC 7
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| Pfizer Inc
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| Vol #:
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| 1
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| EC 8
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| sanofi-aventis
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| Vol #:
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| 1
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| 2007D-0268
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology
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| EC 9
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| Retired
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| Vol #:
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| 1
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| EC 10
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| Mr. robert mickelsen
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| Vol #:
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| 1
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| |
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| 2007N-0262
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
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| |
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| EC 1
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| Mr. Fred Christoffer
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| Vol #:
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| 1
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| EC 2
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| Mr. Thomas Kling
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| Vol #:
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| 1
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| |
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| 2007N-0321
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct
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|
|
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| | |
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| EC 15
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| Breast Cancer Action
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| Vol #:
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| 1
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| 2007N-0347
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| Information Technology Strategic Planning; Public Meeting
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| |
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| EC 5
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| Genzyme Corporation
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| Vol #:
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| 1
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| EC 6
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| Platinum Solutions, Inc.
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| Vol #:
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| 1
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| EC 7
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| GE Healthcare
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| Vol #:
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| 1
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| |
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| EC 8
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| Safe Bio-Pharma Association
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| Vol #:
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| 1
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| EC 9
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| IdenTrust
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| Vol #:
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| 1
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| EC 10
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| CDISC
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| Vol #:
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| 1
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| |
|
|
| 2007N-0356
|
| Behind The Counter
Availability of Certain Drugs; Public Meeting
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| |
|
|
| EAPE 1
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| Baum, Leonard
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| Vol #:
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| 1
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| EAPE 2
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| Trout, Gretchen
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| Vol #:
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| 1
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| |
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| EAPE 3
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| Salmun, Luis
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| Vol #:
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| 1
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| |
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| EAPE 4
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| Ramsey, Valerie
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| Vol #:
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| 1
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| EAPE 5
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| Scott, Sherrie
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| Vol #:
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| 1
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| |
|
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| EAPE 6
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| Fogarty, Helen M.
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| Vol #:
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| 1
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| |
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| EAPE 7
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| Williams, Alissa
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| Vol #:
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| 1
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| EAPE 8
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| Yenyo, Amy
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| Vol #:
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| 1
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| | | | | | | |
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| EAPE 9
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| Neumann, Stephen
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| Vol #:
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| 1
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| EAPE 10
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| Stewart, Emily
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| Vol #:
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| 1
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| |
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| EAPE 11
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| Payne, Jacqueline
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| Vol #:
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| 1
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| |
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| EAPE 12
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| Hilfiker, David
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| Vol #:
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| 1
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| |
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| EAPE 13
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| Smith , Candace
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| Vol #:
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| 1
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| EAPE 14
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| De Jesus, Maricel
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| Vol #:
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| 1
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| EAPE 15
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| Totman, Lorna
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| Vol #:
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| 1
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| EAPE 16
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| Hemwall, Edwin
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| Vol #:
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| 1
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| EAPE 17
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| Ahrens, Ron
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| Vol #:
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| 1
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| EAPE 18
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| Hansen, Jerry
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| Vol #:
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| 1
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| EAPE 19
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| Kowalski, Robert
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| Vol #:
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| 1
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| EAPE 20
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| Bishop, Susan
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| Vol #:
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| 1
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| EAPE 21
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| Friedman, Carola
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| Vol #:
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| 1
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| EAPE 22
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| Traynor, Kate
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| Vol #:
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| 1
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| EAPE 23
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| Casdin, Eli
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| Vol #:
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| 1
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| EAPE 24
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| Hetrick, Lauren
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| Vol #:
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| 1
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| EAPE 25
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| Strickland, Dennis
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| Vol #:
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| 1
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| EAPE 26
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| Wright, Patrice
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| Vol #:
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| 1
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| |
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| EAPE 27
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| Baylor-Henry, Minnie
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| Vol #:
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| 1
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| |
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| EAPE 28
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| Pawelski, Lynn
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| Vol #:
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| 1
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| |
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| EAPE 29
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| Kohler, Robert
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| Vol #:
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| 1
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| |
|
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| EAPE 30
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| O'Neil, Bob
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| Vol #:
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| 1
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| |
|
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| EAPE 31
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| Ralls-Morrison, Desiree
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| Vol #:
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| 1
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| EAPE 32
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| Brandel, Abigail
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| Vol #:
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| 1
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| |
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| EAPE 33
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| McEvoy, Ashley
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| Vol #:
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| 1
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| |
|
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| EAPE 34
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| Crane, Rosemary
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| Vol #:
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| 1
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| |
|
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| EAPE 35
|
| Soller, William
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| Vol #:
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| 1
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| |
|
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| EAPE 36
|
| Mack, John
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| Vol #:
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| 1
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| |
|
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| EAPE 37
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| Leger, Marie-Michele
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| Vol #:
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| 1
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| |
|
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| EAPE 38
|
| Reim, David
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| Vol #:
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| 1
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| |
|
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| EAPE 39
|
| Rinkunas, Maureen
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| Vol #:
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| 1
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| |
|
|
| EAPE 40
|
| Schumaker, Cathie
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| Vol #:
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| 1
|
| |
|
|
| EAPE 41
|
| White, Erinn
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| Vol #:
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| 1
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| |
|
|
| EAPE 42
|
| Rzadzki, John
|
| Vol #:
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| 1
|
| |
|
|
| EAPE 43
|
| White, Erinn
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 44
|
| Keravich, Dan
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 45
|
| Pierro, Nancy
|
| Vol #:
|
| 1
|
|
| | | | | | | |
|
| |
|
| EAPE 46
|
| Cochran, William
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 47
|
| Barba, Stephenie
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 48
|
| Greenbaum, Alexandra
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 49
|
| Levy-Cantor, Susan
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 50
|
| Miller-Rich, Nancy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 51
|
| Miller-Rich, Nancy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 52
|
| James, Susan
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 53
|
| Howard, Marcia
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 54
|
| Slivka, William
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 55
|
| Quesnelle, George M.
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 56
|
| Booth, Bob
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 57
|
| Coster, John
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 58
|
| Jenkins-Showalter, Janet
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 59
|
| Schifkovitz, David
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 60
|
| James, Sue
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 61
|
| KHAN, SAIMA
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 62
|
| Horn, Heidi
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 63
|
| Noble, Ben
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 64
|
| Webb, C. Edwin
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 65
|
| Nowak, Robert
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 66
|
| Monserrate, Dora
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 67
|
| Anderson, Patrick
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 68
|
| Schifkovitz, David
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 69
|
| Styrt, Barbara
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 70
|
| Lonardo, Mimi
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 71
|
| Senak, Mark
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 72
|
| Quesnelle, George M.
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 73
|
| Wong, Hui-Hsing
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 74
|
| Mason, David
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 75
|
| McGlew, John
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 76
|
| Legreid Dopp, Anna
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 77
|
| Matzke, Gary
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 78
|
| Jodrey, Darrel
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 79
|
| Hauser, Ronna
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 80
|
| Bryers, Paul
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 81
|
| Quinn, Lauren
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 82
|
| Berlin, Roger
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| EAPE 83
|
| Coleman, Susan Lavine
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 84
|
| Brabant, Suzanne
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 85
|
| Buono, Lisa
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 86
|
| White, Deborah
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 87
|
| Harley, Eileen
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 88
|
| Zellmer, William
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 89
|
| Coffey, Justine
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 90
|
| Cloud-Dugan, Noello
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 91
|
| Mann, Steve
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 92
|
| O'Neil, Robert
|
| Vol #:
|
| 1
|
| |
|
|
| EC 1
|
| Dr. Robert Paone
|
| Vol #:
|
| 1
|
| |
|
|
| EC 2
|
| Mr. Nathan Housley
|
| Vol #:
|
| 1
|
| |
|
|
| EC 3
|
| VirSci Corporation
|
| Vol #:
|
| 1
|
| |
|
|
| EC 4
|
| Mr. Jack Akers
|
| Vol #:
|
| 1
|
| |
|
|
| EC 5
|
| Ms. Amy Miller
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0389
|
| Granisetron Hydrochloride Injection and 180-day generic drug exclusivity
|
| |
|
|
| LET 1
|
| Teva Parenteral Medicines, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0232
|
| Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release
|
| |
|
|
| EC 2
|
| Mr. Dave Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0282
|
| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
|
| |
|
|
| EC 65
|
| Ms. Kari Little
|
| Vol #:
|
| 1
|
| |
|
|
| EC 66
|
| Mr. David Wortheim
|
| Vol #:
|
| 1
|
| |
|
|
| EC 67
|
| VPIRG
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0295
|
| Make a determination that Inderal (Propranolol Hydrochloride Tablets, 10 mg and 20 mg, NDA 016418, Product Numbers 001 and 003 respectively) held by Wyeth Pharmaceuticals, Inc., were not discontinued
|
|
|
|
|
|
| | |
|
|
| EC 1
|
| Ms. Dave Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0297
|
| Request to reconsider the failure to approve Provenge
|
| |
|
|
| EC 126
|
| Ms. gretchen wallerich
|
| Vol #:
|
| 1
|
| |
|
|
| EC 127
|
| Mr. Leonard Bonn
|
| Vol #:
|
| 1
|
| |
|
|
| EC 128
|
| Mr. Kyle Barbot
|
| Vol #:
|
| 1
|
| |
|
|
| EC 129
|
| Dr. Giancarlo Nicoli
|
| Vol #:
|
| 1
|
| |
|
|
| EC 130
|
| Mr. Yun Zhang
|
| Vol #:
|
| 1
|
| |
|
|
| EC 131
|
| Mr. James Rehm
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0320
|
| Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
|
|
| | | | | | | | |
|
| |
|
| EC 11
|
| Mrs. Mary-Beth Garutti, RN, BSN
|
| Vol #:
|
| 1
|
| |
|
|
| EC 12
|
| Dr. Therese Dowd
|
| Vol #:
|
| 1
|
| |
|
|
| EC 13
|
| Ms. Katrina Spade
|
| Vol #:
|
| 1
|
| |
|
|
| EC 14
|
| community healthcare clinic
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0331
|
| Ban Use of Mercury In Medicine,UNLESS Proven Toxicologically Safe to the CGMP Standard Sufficiently Nontoxic
|
| |
|
|
| EC 4
|
| Mrs. Gail Hardy
|
| Vol #:
|
| 2
|
| |
|
|
| 2007P-0333
|
| Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa
|
|
|
|
|
|
|
|
|
| ACK 9
|
| FDA/DDM to Michael F. Clark
|
| Vol #:
|
| 1
|
| |
|
|
| CP 9
|
| Michael F. Clark
|
| Vol #:
|
| 1
|
|
|
