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| Dockets Entered On
November 2, 2005
Table of Contents
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| Docket #
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| Title
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| 1976N-0052G
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| OTC general comments & combinations
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| |
|
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| 1995N-0294
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| Quality/fill container; common or unusual name regulations
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| |
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
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|
| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| |
|
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| 2002P-0116
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| Sec. 480.200 Expiration Dating of Unit Dose Repackaged Drugs
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| |
|
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| |
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| |
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| 2005D-0240
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| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
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| |
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| 2005M-0378
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| P930014/S015 - ACRYSOF Toric Posterior Chamber Intraocular Lens, Approved 9/14/05
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| 2005N-0311
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| Critical Path Initiative; Developing Prevention Therapies; Planning of Workshop
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| |
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| 2005N-0404
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| Solicitation of Public Review and Comment on Research Protocol:
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| 2005P-0166
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| to prevent the unlawful misbranding of prescription distance glasses and contact lenses
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| 2005P-0167
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| Require Celgene Corporation to Revise the Labeling of Thalomid Capsules to Strengthen Warnings of the Potential for Serious Adverse Events
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| 2005P-0168
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| Determine whether Aeroseb-Dex (Dexamethasone) Topical Aerosol, 0.01%, ( NDA 083-296 ) has been voluntarily withdrawn for safety or efficacy reasons
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| 2005P-0173
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| Request uniform professional labeling for Promethazine Hydrochloride Syrup, USP
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| 2005P-0273
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| Add Calcium to the Mandatory List
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2005P-0441
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| Reservoir Systems for Transdermal Delivery
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| 2005P-0442
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| For patient safety and public health considerations, noted below recommend scheduling tramadol under the Controlled Substances Act
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| 1976N-0052G
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| OTC general comments & combinations
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|
| M
1
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| HF-26 to Division of Dockets Management
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| Vol #:
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| 35
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| 1995N-0294
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| Quality/fill container; common or unusual name regulations
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| C
107
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| Center for Science in the Public Interest (CSPI)
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| Vol #:
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| 5
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16731
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| Pharmavite LLC
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| Vol #:
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| 150
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| LET
16732
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| Pharmavite LLC
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| Vol #:
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| 150
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| LET
16733
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| Advocare International, L.P.
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| Vol #:
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| 150
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| LET
16734
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| Advocare International, L.P.
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| Vol #:
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| 150
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| LET
16735
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| Pharmavite LLC
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| Vol #:
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| 150
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| LET
16736
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| Aboca USA Inc.
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| Vol #:
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| 150
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| LET
16737
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| Cevena Bioproducts Inc.
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| Vol #:
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| 150
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| LET
16738
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| Doctor's Best, Inc.
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| Vol #:
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| 150
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| LET
16739
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| Anabolic Laboratories, Inc.
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| Vol #:
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| 151
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| LET
16740
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| Anabolic Laboratories, Inc.
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| Vol #:
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| 151
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| LET
16741
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| Anabolic Laboratories, Inc.
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| Vol #:
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| 151
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| LET
16742
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| Anabolic Laboratories, Inc.
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| Vol #:
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| 151
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| LET
16743
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| Anabolic Laboratories, Inc.
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| Vol #:
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| 151
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| LET
16744
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| Shaklee Corporation
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| Vol #:
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| 151
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| LET
16745
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| Shaklee Corporation
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| Vol #:
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| 151
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| LET
16746
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| Natrol, Inc.
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| Vol #:
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| 151
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| LET
16747
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| Natrol, Inc.
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| Vol #:
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| 151
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| LET
16748
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| Diamond - Herpanacine Associates
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| Vol #:
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| 151
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| LET
16749
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| Enzymatic Therapy
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| Vol #:
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| 151
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| LET
16750
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| Hansen Beverage Company
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| Vol #:
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| 151
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| LET
16751
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| Lost Beverage Company
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| Vol #:
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| 151
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| LET
16752
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| Hillestad Pharmaceuticals
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| Vol #:
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| 151
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| |
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| |
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|
| EMC 804
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| S. Smith
|
| Vol #:
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| 33
|
| |
|
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| 2002P-0116
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| Sec. 480.200 Expiration Dating of Unit Dose Repackaged Drugs
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| |
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|
| PAV
1
FR,
Guidance
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| HFC-1 to Peiser & Associates, Inc.
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| Vol #:
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| 1
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| |
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| CS 17
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| HFA-305
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| Vol #:
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| 10
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| MO 14
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| Ecumed Health Group, Amador Reyes, Juan C. Carrai, and Michard W. Stone, M.D.
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| Vol #:
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| 10
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| OR 16
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| HF-3 to Ecumed Health Group, and Amador Reyes, Juan C. Carrai, Richard Stone, M.D.
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| Vol #:
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| 10
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| RMO 5
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| GCF-1 to Ecumed Health Group, Amador Reyes, Juan C. Carrai and Richard W. Stone
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| Vol #:
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| 10
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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|
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| C
18
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| Wyeth Pharmaceuticals (Wyeth)
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| Vol #:
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| 5
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| |
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| 2005D-0240
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| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
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| C
8
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| Procter & Gamble Company
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| Vol #:
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| 2
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| 2005M-0378
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| P930014/S015 - ACRYSOF Toric Posterior Chamber Intraocular Lens, Approved 9/14/05
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| CR
1
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| Alcon Research Ltd.
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| Vol #:
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| 1
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| |
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| 2005N-0311
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| Critical Path Initiative; Developing Prevention Therapies; Planning of Workshop
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|
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| C
2
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| Pfizer, Inc.
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| Vol #:
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| 1
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| C
3
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| American Society of Clinical Oncology (ASCO)
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| Vol #:
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| 1
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| EMC
2
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| AIDS Vaccine Advocacy Coalition (AVAC)
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| Vol #:
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| 1
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| EMC
3
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| Starpharma Limited
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| Vol #:
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| 1
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| C
351
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| United States Senate
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| Vol #:
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| 34
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| C
352
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| Friends of Hillary
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| Vol #:
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| 35
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| C 353
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| B. Barron
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| Vol #:
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| 27
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| C
354
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| Planned Parenthood of North Texas (PPNT)
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| Vol #:
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| 27
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| C 355
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| P. Sonntag
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| Vol #:
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| 27
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| C 356
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| P. Kenney
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| Vol #:
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| 27
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| C 357
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| H. Nie
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| Vol #:
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| 27
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| C 358
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| D. Nie
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| Vol #:
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| 27
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| C 359
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| A. Kulczyckyt
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| Vol #:
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| 27
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| C 360
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| G. Hurley
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| Vol #:
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| 27
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| |
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| C 361
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| Illegible
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| Vol #:
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| 27
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| |
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| C 362
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| T. Roonly
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| Vol #:
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| 27
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| |
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| C 363
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| D. Neron
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| Vol #:
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| 27
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| |
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| C 364
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| E. O'Donnell
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| Vol #:
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| 27
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| |
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| C 365
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| S. Romich
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| Vol #:
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| 27
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| |
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| C 366
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| No signature
|
| Vol #:
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| 27
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| |
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| C 367
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| L. Kozak
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| Vol #:
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| 27
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| |
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| C 368
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| E. Jefferies
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| Vol #:
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| 27
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| |
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| C 369
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| Illegible
|
| Vol #:
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| 27
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| |
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| C 370
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| B. Altier
|
| Vol #:
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| 27
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| |
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| C 371
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| M. Johnston
|
| Vol #:
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| 27
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| |
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| C 372
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| K. Jefferies
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| Vol #:
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| 27
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| |
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| C 373
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| E. Jefferis
|
| Vol #:
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| 27
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| |
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| C 374
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| L. McGuire
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| Vol #:
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| 27
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| |
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| C 375
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| C. Jacobs
|
| Vol #:
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| 27
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| |
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| C 376
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| F. Depman
|
| Vol #:
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| 27
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| |
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| C 377
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| T. Gutherman
|
| Vol #:
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| 27
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| |
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| C 378
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| J and D Pizzino
|
| Vol #:
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| 27
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| |
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| C 379
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| A. Condodina
|
| Vol #:
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| 27
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| |
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| C 380
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| A. Dimitri
|
| Vol #:
|
| 27
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| |
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| C
381
|
| Women's Bar Association of the State of New York (WBASNY)
|
| Vol #:
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| 27
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| |
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| C 382
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| W. Weisbrod, MD
|
| Vol #:
|
| 27
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| | | | | | | |
| |
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| C
383
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| National Women's Law Center
|
| Vol #:
|
| 27
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| |
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| C 384
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| No signature
|
| Vol #:
|
| 27
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| |
|
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| C
385
Attachment
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| American College of Obstetricians and Gynecologists (ACOG)
|
| Vol #:
|
| 27
|
| |
|
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| C 386
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| Advocates for Youth et al.
|
| Vol #:
|
| 27
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| |
|
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| C 387
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| Illegible
|
| Vol #:
|
| 27
|
| |
|
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| C 388
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| M. Christof
|
| Vol #:
|
| 27
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| |
|
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| C 389
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| L. Vandeventer
|
| Vol #:
|
| 27
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| |
|
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| C 390
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| D and L Mulhall
|
| Vol #:
|
| 27
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| |
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| C 391
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| M. Hogan
|
| Vol #:
|
| 27
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| |
|
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| C 392
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| M. Ladise
|
| Vol #:
|
| 27
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| |
|
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| C 393
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| E. Kane
|
| Vol #:
|
| 27
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| |
|
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| C 394
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| J. Devine
|
| Vol #:
|
| 27
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| |
|
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| C
395
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| National Organization for Women
|
| Vol #:
|
| 27
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| |
|
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| C 396
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| K. Raviele, M.D.
|
| Vol #:
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| 27
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| |
|
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| C 397
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| R. Sedlock
|
| Vol #:
|
| 27
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| |
|
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| C 398
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| E. Rowen
|
| Vol #:
|
| 27
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| |
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| C 399
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| P. Armeli
|
| Vol #:
|
| 27
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| |
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| C 400
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| J. McLaughlin
|
| Vol #:
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| 27
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| |
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| C 401
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| A. Hinnegan
|
| Vol #:
|
| 27
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| |
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| C 402
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| F. Brady
|
| Vol #:
|
| 27
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| |
|
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| C
403
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| Arnall Golden Gregory. LLP
|
| Vol #:
|
| 27
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| |
|
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| C 404
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| M. Glatz
|
| Vol #:
|
| 27
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| |
|
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| C 405
|
| K. Medary
|
| Vol #:
|
| 27
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| |
|
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| C
406
|
| Missouri Family Health Council, Inc.
|
| Vol #:
|
| 27
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| |
|
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| C
407
|
| Pfizer, Inc.
|
| Vol #:
|
| 27
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| |
|
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| C
408
|
| Sexuality Information and Education Council of the United States (SIECUS)
|
| Vol #:
|
| 27
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| |
|
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| C 409
|
| S. Nortwick
|
| Vol #:
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| 27
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| |
|
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| C 410
|
| A. Barta, M.D.
|
| Vol #:
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| 27
|
| |
|
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| C
411
|
| Population Connection
|
| Vol #:
|
| 36
|
| |
|
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| C
412
|
| Consumer Healthcare Products Association (CHPA)
|
| Vol #:
|
| 36
|
| |
|
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| C 413
|
| K. Jennings
|
| Vol #:
|
| 36
|
| |
|
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| C
414
|
| Kirkpatrick & Lockhart Nicholson Graham (K&LNG)
|
| Vol #:
|
| 36
|
| |
|
|
| C
415
|
| Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)
|
| Vol #:
|
| 36
|
| |
|
|
| C 416
|
| R. Cassidy
|
| Vol #:
|
| 36
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| |
|
|
| C 417
|
| V. Rossi, MD
|
| Vol #:
|
| 36
|
| |
|
|
| C 418
|
| M. Wurtz
|
| Vol #:
|
| 36
|
| |
|
|
| C 419
|
| E. Tefft
|
| Vol #:
|
| 36
|
|
| | | | | | | |
| |
|
|
| C 420
|
| W. Gallagher, III
|
| Vol #:
|
| 36
|
| |
|
|
| C 421
|
| J. Niederhaus
|
| Vol #:
|
| 36
|
| |
|
|
| C 422
|
| M. Desideri
|
| Vol #:
|
| 36
|
| |
|
|
| C 423
|
| R. Suda, MD
|
| Vol #:
|
| 36
|
| |
|
|
| C 424
|
| F. Hamill
|
| Vol #:
|
| 36
|
| |
|
|
| C 425
|
| M. Teply
|
| Vol #:
|
| 36
|
| |
|
|
| C 426
|
| M. Heigh
|
| Vol #:
|
| 36
|
| |
|
|
| C 427
|
| J. Hahn
|
| Vol #:
|
| 36
|
| |
|
|
| C
428
|
| Planned Parenthood of Greater Cleveland
|
| Vol #:
|
| 36
|
| |
|
|
| C 429
|
| S. Cooney
|
| Vol #:
|
| 36
|
| |
|
|
| C 430
|
| H. and J. Donohue
|
| Vol #:
|
| 36
|
| |
|
|
| C 431
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| Mr and Mrs W. Small
|
| Vol #:
|
| 36
|
| |
|
|
| C 432
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| C. Bartenbach
|
| Vol #:
|
| 36
|
| |
|
|
| C 433
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| R. Johnson
|
| Vol #:
|
| 36
|
| |
|
|
| C 434
|
| K. McSorley
|
| Vol #:
|
| 36
|
| |
|
|
| C 435
|
| C. Mellon
|
| Vol #:
|
| 36
|
| |
|
|
| C 436
|
| J. Gill
|
| Vol #:
|
| 36
|
| |
|
|
| C 437
|
| D. Bidey
|
| Vol #:
|
| 36
|
| |
|
|
| C 438
|
| R. Moughan
|
| Vol #:
|
| 36
|
| |
|
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| C 439
|
| L. McQueen
|
| Vol #:
|
| 36
|
| |
|
|
| C 440
|
| J. Rihl
|
| Vol #:
|
| 36
|
| |
|
|
| C 441
|
| M. Fennessy
|
| Vol #:
|
| 36
|
| |
|
|
| C 442
|
| D and L Egel
|
| Vol #:
|
| 36
|
| |
|
|
| C
443
|
| National Association of Boards of Pharmacy (NABP)
|
| Vol #:
|
| 36
|
| |
|
|
| C 444
|
| G. Connelly
|
| Vol #:
|
| 36
|
| |
|
|
| C 445
|
| Form Letters
|
| Vol #:
|
| 37
|
| |
|
|
| C 446
|
| Form Letters
|
| Vol #:
|
| 38
|
| |
|
|
| EMC 419
|
| A. Weaver
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 420
|
| L. Sweeten
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 421
|
| P. Knight
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 422
|
| T. White
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 423
|
| D. Porter
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 424
|
| K. Pence
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 425
|
| N. Schwab
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 426
|
| J. Irons
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 427
|
| L. Tesmer
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 428
|
| J. Schhadt
|
| Vol #:
|
| 33
|
|
| | | | | | | | |
| |
|
|
| EMC 429
|
| E. Rahn
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 430
|
| L. Walker
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 431
|
| T. Fischman
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 432
|
| C. Hill
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 433
|
| D. Knauer
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 434
|
| M. Guilfoyle
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 435
|
| M. Samuelsen
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 436
|
| A. Neacsu
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 437
|
| A. Carroll
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 438
|
| M. Hozempa
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 439
|
| E. O'Malley
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 440
|
| M. Mills
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 441
|
| W. Depner
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 442
|
| B. Newman
|
| Vol #:
|
| 33
|
| |
|
|
| EMC
443
|
| Planned Parenthood of New Mexico, Inc.
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 444
|
| C. Youm
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 445
|
| G. Raffa
|
| Vol #:
|
| 33
|
| |
|
|
| EMC
446
|
| American Civil Liberties Union (ACLU)
|
| Vol #:
|
| 33
|
| |
|
|
| 2005N-0354
|
| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
| |
|
|
| C
2
|
| AstraZeneca LP
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 44
|
| L. Clift
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 45
|
| F. Heckman
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 46
|
| H. May
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 47
|
| R. Gerstner
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 48
|
| R. Gerstner
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 49
|
| D. Lankau
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 50
|
| D. Lankau
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 51
|
| S. McDaniel
|
| Vol #:
|
| 2
|
| |
|
|
| 2005N-0404
|
| Solicitation of Public Review and Comment on Research Protocol:
|
| |
|
|
| C
2
|
| The Lawson Wilkins Pediatric Endocrine Society
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0166
|
| to prevent the unlawful misbranding of prescription distance glasses and contact lenses
|
| |
|
|
| LET
1
|
| HFZ-001 to International Myopia Prevention Association
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0167
|
| Require Celgene Corporation to Revise the Labeling of Thalomid Capsules to Strengthen Warnings of the Potential for Serious Adverse Events
|
| |
|
|
| LET
1
|
| HFD-005 to State of Connecticut
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
| |
|
| 2005P-0168
|
| Determine whether Aeroseb-Dex (Dexamethasone) Topical Aerosol, 0.01%, ( NDA 083-296 ) has been voluntarily withdrawn for safety or efficacy reasons
|
| |
|
|
| LET
1
|
| HFD-005 to ACADERM Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0173
|
| Request uniform professional labeling for Promethazine Hydrochloride Syrup, USP
|
| |
|
|
| LET
1
|
| HFD-005 to Buchanan Ingersoll, PC
|
| Vol #:
|
| 1
|
|
| |
|
| 2005P-0267
|
| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
|
| |
|
|
| C 38
|
| W. Brian, M.D.
|
| Vol #:
|
| 13
|
| |
|
|
| C 39
|
| D. Meredith, CRNA
|
| Vol #:
|
| 13
|
| |
|
|
| C 40
|
| P. Zitello, M.D.
|
| Vol #:
|
| 13
|
| |
|
|
| C 41
|
| C. Ivie, D.O.
|
| Vol #:
|
| 13
|
| |
|
|
| C 42
|
| R. Krishna, M.D.
|
| Vol #:
|
| 13
|
| |
|
|
| 2005P-0273
|
| Add Calcium to the Mandatory List
|
| |
|
|
| C
3
|
| Mayo Clinic
|
| Vol #:
|
| 2
|
| |
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
| |
|
|
| C
1
|
| Blanchard Valley Medical Associates (BVMA)
|
| Vol #:
|
| 1
|
| |
|
|
| C
2
|
| National Black Women's Health Project, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0441
|
| Reservoir Systems for Transdermal Delivery
|
| |
|
|
| ACK
1
|
| HFA-305 to Gordon L. Flynn, Ph.D
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
Attached CV
|
| Gordon L. Flynn, Ph.D.
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0442
|
| For patient safety and public health considerations, noted below recommend scheduling tramadol under the Controlled Substances Act
|
| |
|
|
| ACK
1
|
| HFA-305 to Pine Grove Behavioral Health & Addiction Services
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Pine Grove Behavioral Health & Addiction Services
|
| Vol #:
|
| 1
|
|
|
