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| Dockets Entered
On April 28, 2004
Table of Contents
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| Docket #
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| Title
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| 1977N-0094
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| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003D-0570
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| Draft on the Clinical Evaluation of Weight-Control Drugs
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| 2003D-0571
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| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| 2003P-0363
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| Professional and Patient Labeling for Hearing Aid Devices
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| 2004D-0028
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| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
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| 2004D-0042
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| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
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| 2004D-0192
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| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Using Screening Human Donors of Blood and Blood Components Draft Guidance
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| 2004N-0115
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| Prescription Drug Importation Study
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| 2004P-0091
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| To premarket approval (PMA) for the gastric electrical stimulation ( GES), level III device, enterra therapy, for the treatment of severe nausea and vomiting from gastroparesis
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| 1977N-0094
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| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
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| M
11
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| Notice of Feedback Meeting for April 30, 2004 Bayer Healthcare LLC & FDA
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| Vol #:
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| 235
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT
185
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| Atlantic Medical Health Care, Inc. (Distributor)
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| Vol #:
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| 133
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| RPT
186
Attachment
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| Goen Group
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| Vol #:
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| 133
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| RPT
187
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| Co-Creations
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| Vol #:
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| 133
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| RPT
188
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| AHD International, LLC
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| Vol #:
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| 135
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
13836
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| Pure Encapsulations, Inc.
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| Vol #:
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| 117
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| LET
13837
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| Mera Pharmaceuticas
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| Vol #:
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| 117
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| LET
13838
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| Lyons Health Products
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| Vol #:
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| 117
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| LET
13839
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| Doctor's Best, Inc.
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| Vol #:
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| 117
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| LET
13840
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| Source Naturals
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| Vol #:
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| 117
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| LET
13841
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| Optimum Nutrition, Inc.
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| Vol #:
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| 117
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| C
3
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| Jerussi Consulting, Inc.
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| Vol #:
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| 1
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| C
24
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| Bureau of Economics, the Bureau of Consumer Protection, and the Office f Policy Planning of the FTC
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| Vol #:
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| 7
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| EMC 172
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| M. Greene
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| Vol #:
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| 7
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| EMC 173
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| K. Thomas
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| Vol #:
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| 7
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| EMC 73
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| B. Grand
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| Vol #:
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| 2
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| 2003P-0363
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| Professional and Patient Labeling for Hearing Aid Devices
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| EMC 29
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| B. Grand
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| Vol #:
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| 1
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| EMC
20
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| Children Afflicted By Toxic Substances (CATS)
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| Vol #:
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| 2
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| 2004D-0028
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| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
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| C 32
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| V. Lis
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| Vol #:
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| 1
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| 2004D-0042
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| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
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| C
5
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| Academy of Managed Care Pharmacy (AMCP)
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| Vol #:
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| 1
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| 2004D-0192
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| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Using Screening Human Donors of Blood and Blood Components Draft Guidance
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| EMC
1
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| Plasma Protein Therapeutics Assn (PPTA)
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| Vol #:
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| 1
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| EMC
2
Attachment
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| Plasma Protein Therapeutics Assn (PPTA)
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| Vol #:
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| 1
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| 2004N-0115
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| Prescription Drug Importation Study
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| EMC
8
Attachment
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| Boston University School of Public Health
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| Vol #:
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| 3
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| EMC
9
Attachment
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| Boston University School of Public Health
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| Vol #:
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| 3
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| TS
24
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| Christensen, Miller, Fink, Jacobs, Glaser, Weil & Shapiro, LLP
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| Vol #:
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| 3
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| TS
25
Powerpoint
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| Consumer Project Technology (CPTech)
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| Vol #:
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| 3
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| 2004P-0091
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| To premarket approval (PMA) for the gastric electrical stimulation ( GES), level III device, enterra therapy, for the treatment of severe nausea and vomiting from gastroparesis
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| EMC 5
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| L. Ferrari
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| Vol #:
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| 1
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