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Donor History Questionnaire and Accompanying Materials for Using Screening Human Donors of Blood and Blood Components Draft Guidance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