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| Dockets Entered
On September 7, 2004
Table of Contents
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| Docket
#
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| Title
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| 1990P-0201
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| Optimum size &
Style of print to be used to label OTC Drugs
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| 1994P-0390
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| Adopt Amendments Governing Health
Claims & Nutrient Claims
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| 1995N-0259
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| Over the Counter Drug
Labeling; Public Hearing
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| 1995S-0316
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| 75-Day Premarket Notifications
for New Dietary Ingredients
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| 1996N-0420
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| OTC Human Drugs; Proposed
Labeling Requirements
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| 1997S-0163
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| Dietary Supplements,
Courtesy Letters (Letters of Objection)
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| 1998N-0337
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| Over the counter human
drugs labeling requirements
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| 2001P-0075
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| Switch Status of Emergency
Contraceptives from Rx to OTC
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| 2003N-0539
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| Over-the-Counter Drug
Products; Safety and Efficacy Review
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| 2004D-0198
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| Guidance for Industry: Acceptable
Full-Length Donor History Questionnaire and Accompanying Materials
for Use in Screening Human Donors of Blood and Blood Components
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| 2004N-0133
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| Part 11, Electronic Record;
Electronic Signatures; Public Meeting
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| 2004N-0346
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| Over-the-Counter Drug Products;
Safety and Efficacy Review; Additional Antidiarrheal Ingredient
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| 2004P-0113
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| immediately remove
from the market rosuvastatin (Crestor-AstraZeneca) before additional
cases of life-threatening rhabdomyolysis and kidney/failure damage
occur
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| 2004P-0365
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| Refrain from approving
ANDA for Agrylin (anagrelide hydrochloride) Capsules
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| 2004Q-0102
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| Qualified Health Claim:
Calcium and Kidney/urinary stones
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| 2004Q-0180
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| Qualified Health Claim
(QHC): Lutein and Eye Diseases
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| 2004Q-0201
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| Qualified Health Claim
(QHC): Lycopene, Tomatoes and Various Cancers
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| 2004S-0170
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| Medicare Prescription
Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest
Priority Topics for Research
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| 1990P-0201
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| Optimum size &
Style of print to be used to label OTC Drugs
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| NFR
4
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| FDA
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| Vol #:
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| 8
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| 1994P-0390
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| Adopt Amendments
Governing Health Claims & Nutrient Claims
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| EC
3
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| American Bakers Association
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| Vol #:
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| 7
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| EC
4
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| American Bakers Association
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| Vol #:
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| 7
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| EC
5
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| Grocery Manufacturers
of America
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| Vol #:
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| 7
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| 1995N-0259
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| Over the Counter
Drug Labeling; Public Hearing
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| NFR
4
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| FDA
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| Vol #:
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| 13
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| 1995S-0316
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| 75-Day Premarket
Notifications for New Dietary Ingredients
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| RPT
233
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| Stage II Enterprises
LLC
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| Vol #:
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| 165
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| RPT
234
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| Nano Port (USA) Inc
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| Vol #:
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| 166
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| 1996N-0420
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| OTC Human Drugs;
Proposed Labeling Requirements
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| NFR
4
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| FDA
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| Vol #:
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| 25
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| 1997S-0163
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| Dietary Supplements,
Courtesy Letters (Letters of Objection)
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| LET
770
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| HFS-800 to Perrigo
Company of South Carolina
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| Vol #:
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| 23
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| LET
771
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| HFS-800 to Leiner
Health Products
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| Vol #:
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| 23
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| 1998N-0337
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| Over the counter
human drugs labeling requirements
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| NFR
4
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| FDA
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| Vol #:
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| 9
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| | | | | | | | |
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C 2023
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| Form Letter Count 70
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| Vol #:
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| 291
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| C 2024
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| Form letter count 46
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| Vol #:
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| 292
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| C 2025
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| Form Letter count 14
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| Vol #:
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| 293
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| 2003N-0539
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| Over-the-Counter Drug Products; Safety and Efficacy Review
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| C
9
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| Instead Inc
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| Vol #:
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| 1
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| 2004D-0198
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| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
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| EC 1
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| University of Iowa Hospitals
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| Vol #:
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| 1
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| EC
2
Attachment
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| America's Blood Centers
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| Vol #:
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| 1
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| EC
3
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| Talisman Limited
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| Vol #:
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| 1
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| 2004N-0133
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| Part 11, Electronic Record; Electronic Signatures; Public Meeting
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| EC
18
Attachment
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| Hitachi, Ltd.
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| Vol #:
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| 6
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| EC
19
Attachment
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| AstraZeneca
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| Vol #:
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| 6
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| EC
20
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| Bristol-Myers Squibb
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| Vol #:
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| 6
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| EC
21
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| Rockwell Automation
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| Vol #:
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| 6
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| EC
22
Attachment
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| Eli Lilly and Company
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| Vol #:
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| 6
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| 2004N-0346
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| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Antidiarrheal Ingredient
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| EC 1
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| private consumer
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| Vol #:
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| 2
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| 2004P-0113
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| immediately remove from the market rosuvastatin (Crestor-AstraZeneca) before additional cases of life-threatening rhabdomyolysis and kidney/failure damage occur
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| C
4
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| Astra Zeneca Pharmaceuticals LP
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| Vol #:
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| 1
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| 2004P-0365
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| Refrain from approving ANDA for Agrylin (anagrelide hydrochloride) Capsules
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| ACK
2
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| HFA-305 to Shire US, Inc.
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| Vol #:
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| 2
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| 2004Q-0102
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| Qualified Health Claim: Calcium and Kidney/urinary stones
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| EMC
2
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| University of Texas Southwestern Medical Center at Dallas
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| Vol #:
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| 6
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| 2004Q-0180
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| Qualified Health Claim (QHC): Lutein and Eye Diseases
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| EMC
1
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| Zeavision, LLC
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| Vol #:
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| 5
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| |
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| 2004Q-0201
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| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
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| C
2
Attachments
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| Campbell Soup Company
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| Vol #:
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| 16
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| EC 3
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| Mr. William DuSold
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| Vol #:
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| 16
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|
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| 2004S-0170
|
| Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
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|
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| EMC
26
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| America's Health Insurance Plans (AHIP)
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| Vol #:
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| 3
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