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| Dockets Entered
On July 27, 2005
Table of Contents
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| Docket #
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| Title
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| 1994N-0418
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| Order for Certain Class III Devices, including S&E info
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutritin
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| 2000N-0504
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| Egg Safety Action Plan
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| 2001C-0486
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| Tomato lycopene extract to color foods generally
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| 2002E-0097
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| Patent Term Application for Clarinex
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| 2002E-0344
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| Patent Term Application for ATS Open Pivot Bileaf Valve 5,35
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| 2004N-0565
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| Agency Information Collection Activities; Proposed Collection;
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| 2004P-0105
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| Nutrient Content Claim: Total Carbohydrate Content of Foods
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| 2005D-0261
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| Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
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| 2005M-0289
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| Premarket Approval for St. Jude Medical Frontier TM Model 5508L & Frontier TM II Model 5586 Cardiac Resynchronization Therapy Pacemakers, P030035/S003
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| 2005N-0012
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Allergen Labeling of Food Products Consumer Preference Survey and Experimental Study on Allergen Labeling of Food Produc
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| 2005N-0147
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| Sprout Safety Public Meeting
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| 2005P-0094
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| Remove the drug Iressa (gefitnib; AstraZeneca) from the market immediately
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| 1994N-0418
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| Order for Certain Class III Devices, including S&E info
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| LET
3
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| HFZ-400 to American Heart Association
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| Vol #:
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| 23
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16372
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| New Chapter, Inc.
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| Vol #:
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| 146
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| LET
16373
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| New Chapter, Inc.
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| Vol #:
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| 146
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| LET
16374
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| New Chapter, Inc.
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| Vol #:
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| 146
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| LET
16375
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| New Chapter, Inc.
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| Vol #:
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| 146
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| LET
16376
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| New Chapter, Inc.
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| Vol #:
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| 146
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| LET
16377
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| New Chapter, Inc.
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| Vol #:
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| 146
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| LET
16378
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| New Chapter, Inc.
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| Vol #:
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| 146
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| LET
16379
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| New Chapter, Inc.
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| Vol #:
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| 146
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| LET
16380
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| New Chapter, Inc.
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| Vol #:
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| 146
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| LET
16381
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| New Chapter, Inc.
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| Vol #:
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| 146
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| LET
16382
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| New Chapter, Inc.
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| Vol #:
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| 146
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| LET
16383
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| New Chapter, Inc.
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| Vol #:
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| 146
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| LET
16384
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| New Chapter, Inc.
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| Vol #:
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| 146
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| LET
16385
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| Nature's Way Products, Inc.
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| Vol #:
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| 146
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| LET
16386
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| Nature's Way Products, Inc.
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| Vol #:
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| 146
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| LET
16387
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| BioZak Botanical, Inc.
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| Vol #:
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| 146
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| LET
16388
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| Enzymatic Therapy
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| Vol #:
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| 146
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| LET
16389
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| Enzymatic Therapy
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| Vol #:
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| 146
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| LET
16390
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| Enzymatic Therapy
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| Vol #:
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| 146
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| LET
16391
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| Perrigo Company of South Carolina
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| Vol #:
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| 146
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| LET
16392
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| Perrigo Company of South Carolina
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| Vol #:
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| 146
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| LET
16393
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| Perrigo Company of South Carlina
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| Vol #:
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| 146
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| LET
16394
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| Perrigo Company of South Carolina
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| Vol #:
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| 146
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| LET
16395
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| Perrigo Company of South Carolina
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| Vol #:
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| 146
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| LET
16396
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| Perrigo Company of South Carolina
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| Vol #:
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| 146
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| LET
16397
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| Perrigo Company of South Carolina
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| Vol #:
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| 146
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| LET
16398
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| Enzymatic Therapy
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| Vol #:
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| 146
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| LET
16399
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| Fun Energy Foods, Inc.
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| Vol #:
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| 146
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutritin
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| C
120
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| Center for Science in the Public Interest (CSPI)
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| Vol #:
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| 9
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| 2000N-0504
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| Egg Safety Action Plan
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| C
382
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| Consumer Federation of America (CFA)
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| Vol #:
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| 32
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| C
383
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| United Egg Producers (UEP)
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| Vol #:
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| 32
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| 2001C-0486
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| Tomato lycopene extract to color foods generally
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| NFR
1
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| FDA
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| Vol #:
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| 1
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| 2002E-0097
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| Patent Term Application for Clarinex
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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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| 2002E-0344
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| Patent Term Application for ATS Open Pivot Bileaf Valve 5,35
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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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| 2004N-0565
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| Agency Information Collection Activities; Proposed Collection;
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| NAL
2
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| FDA
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| Vol #:
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| 1
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| SS
2
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| Supporting Statement on Application for Temporary Marketing Permits
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| Vol #:
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| 1
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| 2004P-0105
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| Nutrient Content Claim: Total Carbohydrate Content of Foods
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| LET
6
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| Kraft Foods Global Inc
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| Vol #:
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| 1
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| C
7
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| American Society of Health-System Pharmacists (ASHP)
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| Vol #:
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| 1
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| SUP
1
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| American Society of Health-System Pharmacists (ASHP)
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| Vol #:
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| 1
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| | | | | | | | |
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| 2005D-0261
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| Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
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| GDL
1
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| Guideline
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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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| 2005M-0289
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| Premarket Approval for St. Jude Medical Frontier TM Model 5508L & Frontier TM II Model 5586 Cardiac Resynchronization Therapy Pacemakers, P030035/S003
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| AAV
1
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| St. Jude Medical
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| Vol #:
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| 1
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| 2005N-0012
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Allergen Labeling of Food Products Consumer Preference Survey and Experimental Study on Allergen Labeling of Food Produc
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| Supporting Statement for Allergen Labeling of Food Products Consumer Preference Survey and Experi
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| Vol #:
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| 1
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| 2005N-0147
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| Sprout Safety Public Meeting
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| LST
1
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| Agenda for the May 17, 2005 Meeting
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| Vol #:
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| 3
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| TS
1
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| Centers for Disease Control (CDC)
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| Vol #:
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| 3
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| TS
2
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| Food and Drug Administration
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| Vol #:
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| 3
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| TS
3
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| International Sprout Growers Association
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| Vol #:
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| 3
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| TS
4
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| Center for Science in the Public Interest (CSPI)
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| Vol #:
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| 3
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| TS
5
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| John Hopkins School of Medicine
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| Vol #:
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| 3
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| TS 6
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| Food Safety Intervention Technologies RU
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| Vol #:
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| 5
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| TS
7
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| Food and Drug Administration
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| Vol #:
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| 3
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| TS
8
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| Caudill Seed Company
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| Vol #:
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| 3
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| TS
9
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| Rutgers - The State University of NJ
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| Vol #:
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| 3
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| 2005P-0094
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| Remove the drug Iressa (gefitnib; AstraZeneca) from the market immediately
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| C 1
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| AstraZeneca Pharmaceuticals, LP
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| Vol #:
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| 1
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| 2005P-0121
|
| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| C 3
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| N. Partridge, PhD
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| Vol #:
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| 3
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