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| Dockets Entered
On August 6, 2007
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| Docket #
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| Title
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| 1975N-0183F
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| Topical Antimicrobial Drug Products For OTC Human Use - First Aid
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| 1975N-0183H
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| Health-Care Antiseptic Drug Products for OTC Human Use
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| 1976N-0052N
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| OTC Nasal Decongestants
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2005N-0272
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| Irradiation in the Production, Processing & Handling of Food
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| 2006P-0160
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| Change Daranide Tablets, 50 mg to a generic version
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| 2006P-0287
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| Determine Whether Phoslo
(calcium acetate) Tablets, eq 169 mg Calcium, have been voluntarily
withdrawn from sale for safety or efficacy reasons
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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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| 2006P-0399
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| To determine whether PhosLo (calcium acetate) Tablets, eq 169 mg calcium, and PhosLo (calcuim acetate) Capsules, eq 169 mg calcium, has been withdrawn for safety or efficacy reasons
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| 2006P-0446
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| ANDA for PHENERGAN Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg
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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-0125
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| Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
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| 2007M-0303
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| P050024 - CryoCor CryoAblation System
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| 2007N-0179
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| Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges; Public Workshop
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| 2007N-0238
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| Medical Devices: The Mammography Quality Standards Act of 1992 and Subsequent Mammography Quality Standards Reauthorization Act and Amendments; Inspection Fees
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| 1975N-0183F
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| Topical Antimicrobial Drug Products For OTC Human Use - First Aid
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| C 23
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| G. Drexler
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| Vol #:
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| 13
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| 1975N-0183H
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| Health-Care Antiseptic Drug Products for OTC Human Use
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| C 94
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| Greg Drexler
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| Vol #:
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| 204
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| 1976N-0052N
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| OTC Nasal Decongestants
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| C 253
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| Consumer Healthcare Product Association (CHPA)
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| Vol #:
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| 86
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 20525
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| Enzmatic
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| Vol #:
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| 179
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| 2005N-0272
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| Irradiation in the Production, Processing & Handling of Food
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| C 3378
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| V. Kreitling
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| Vol #:
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| 39
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| C 3379
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| M. Lambert
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| Vol #:
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| 39
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| C 3380
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| G. Wood
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| Vol #:
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| 39
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| C 3381
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| J. Reid
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| Vol #:
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| 39
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| C 3382
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| W. E. Baer
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| Vol #:
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| 39
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| C 3383
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| L. Seno
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| Vol #:
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| 39
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| C 3384
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| P. Bacon
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| Vol #:
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| 39
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| C 3385
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| D. Pinkston
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| Vol #:
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| 39
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| C 197
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| J. Hengesbach
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| Vol #:
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| 3
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| C 198
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| D. Morse
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| Vol #:
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| 3
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| C 199
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| E. Maniaci
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| Vol #:
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| 3
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| C 200
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| A. Cunningham
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| Vol #:
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| 3
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| C 201
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| H. Szcyurek
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| Vol #:
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| 3
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| C 202
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| D. Osman
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| Vol #:
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| 3
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| C 203
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| E. Huber
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| Vol #:
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| 3
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| C 204
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| C. Browning
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| Vol #:
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| 3
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| C 205
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| R. Rosenberg
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| Vol #:
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| 3
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| C 206
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| L. Pang
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| Vol #:
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| 3
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| C 207
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| L. Spychalski
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| Vol #:
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| 3
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| C 208
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| E. Warrick
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| Vol #:
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| 3
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| C 209
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| R. Payton
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| Vol #:
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| 3
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| C 210
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| W. Hunt
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| Vol #:
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| 3
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| C 211
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| H. Morton
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| Vol #:
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| 3
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| C 212
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| T. Vogt
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| Vol #:
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| 3
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| C 213
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| G. McMillan
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| Vol #:
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| 3
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| C 214
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| J. Thacher
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| Vol #:
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| 3
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| C 215
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| I. Collazo
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| Vol #:
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| 3
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| 2006P-0160
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| Change Daranide Tablets, 50 mg to a generic version
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| N 1
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| FDA
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| Vol #:
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| 1
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| 2006P-0287
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| Determine Whether
Phoslo (calcium acetate) Tablets, eq 169 mg Calcium, have been voluntarily
withdrawn from sale for safety or efficacy reasons
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| N 1
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| FDA
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| Vol #:
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| 1
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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 126
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| J. Davenport
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| Vol #:
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| 7
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| C 127
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| A. Arbogast
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| Vol #:
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| 7
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| 2006P-0399
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| To determine whether PhosLo (calcium acetate) Tablets, eq 169 mg calcium, and PhosLo (calcuim acetate) Capsules, eq 169 mg calcium, has been withdrawn for safety or efficacy reasons
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| N 1
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| FDA
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| Vol #:
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| 1
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| 2006P-0446
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| ANDA for PHENERGAN Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg
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| N 1
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| FDA
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| Vol #:
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| 1
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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 5
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| Advance Medical Technology Association (AdvaMed)
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| Vol #:
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| 1
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| 2007D-0125
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| Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
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| C 1
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| J. Slama
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| Vol #:
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| 1
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| EXT 1
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| A. Young
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| Vol #:
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| 1
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| 2007M-0303
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| P050024 - CryoCor CryoAblation System
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| AAV 1
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| CryoCor, Inc.
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| Vol #:
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| 1
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| 2007N-0179
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| Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges; Public Workshop
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| TS 3
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| HHS/AHRQ
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| Vol #:
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| 2
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| TS 4
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| FDA
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| Vol #:
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| 2
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| TS 5
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| University of Pennsylvania
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| Vol #:
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| 2
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| TS 6
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| FDA
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| Vol #:
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| 2
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| TS 7
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| Fairfield County MM Support Group
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| Vol #:
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| 2
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| TS 8
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| MS Internet Support Forum
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| Vol #:
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| 2
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| TS 9
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| Blue Cross and Blue Shield
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| Vol #:
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| 2
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| TS 10
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| Blue Cross and Blue Shield
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| Vol #:
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| 2
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| TS 11
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| Kaiser Permanente
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| Vol #:
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| 2
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| TS 12
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| Veteran's Administration
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| Vol #:
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| 2
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| TS 13
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| American Academy of Family Physicians
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| Vol #:
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| 2
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| TS 14
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| Celgene Corporation
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| Vol #:
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| 2
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| TS 15
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| Biogen Idec, Inc.
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| Vol #:
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| 2
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| TS 16
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| AHRQ/FDA
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| Vol #:
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| 2
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| TS 17
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| Duke Center for Education and Research on Therapeutics
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| Vol #:
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| 2
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| TS 18
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| University of Pennsylvania
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| Vol #:
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| 2
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| TS 19
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| FDA
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| Vol #:
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| 2
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| TS 20
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| University of Arizona
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| Vol #:
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| 2
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| TS 21
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| HMO Research Network CERT
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| Vol #:
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| 2
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| TS 22
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| FDA
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| Vol #:
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| 2
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| TS 23
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| National Steering Committee CERT
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| Vol #:
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| 2
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| TS 24
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| National Steering Committee CERT
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| Vol #:
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| 2
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| TS 25
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| Outcome Sciences
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| Vol #:
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| 2
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| TS 26
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| National Health Insurance in Taiwan
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| Vol #:
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| 2
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| TS 27
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| Johnson & Johnson
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| Vol #:
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| 2
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| TS 28
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| American Foundation for Material and Child Health
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| Vol #:
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| 1
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| 2007N-0238
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| Medical Devices: The Mammography Quality Standards Act of 1992 and Subsequent Mammography Quality Standards Reauthorization Act and Amendments; Inspection Fees
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| BKG 1
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| Background Material
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| Vol #:
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| 1
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