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DOCKETS MANAGEMENT

 

Dockets Entered On July 7, 2003

Table of Contents (Linked)

 

 

Docket #

 

Title

 

 

 

 

 

1981N-0033

 

Oral Health Care Drug Products for OTC Human Use

 

 

2002D-0515

 

Health Claims labeling conventional foods/dietary supplement

 

 

2002D-0526

 

Guidance for drug Chemistry, Manufacturing, Control Info.

 

 

2002P-0349

 

Amend product insert and/or label for Hemophilus Vaccines

 

 

2003D-0061

 

Comparability Protocols Chemistry Manufacturing and controls

 

 

2003N-0056

 

Patient Examination & Surgeons' Gloves; Test Procedures

 

 

2003N-0069

 

FDA Task Force on Consumer Health Info for Better Nutrition

 

 

2003N-0169

 

Dental Amalgam; Request for Information

 

 

2003N-0201

 

Minimizing Medication Errors - Methods for Evaluating Proprietary Names for their Confusion Potential; Public Meeting

 

Contents

 

1981N-0033

 

Oral Health Care Drug Products for OTC Human Use

 

 

ACK 3

 

HFA-305 to Associate Head Regulatory Affairs

 

Vol #:

 

58

 

 

 

ACK 4

 

HFA-305 to Associate Head Regulatory Affairs

 

Vol #:

 

58

 

 

 

2002D-0515

 

Health Claims labeling conventional foods/dietary supplement

 

 

EMC 3

 

HFS-22

 

Vol #:

 

1

 

 

 

EMC 4

 

Durk Pearson & Sandy Shaw;Life Extension Foundation, Inc. and Julian M. Whitaker, M.D.

 

Vol #:

 

1

Attachments

 

 

2002D-0526

 

Guidance for drug Chemistry, Manufacturing, Control Info.

 

 

EMC 3

 

Eli Lilly and Company

 

Vol #:

 

1

 

 

 

EMC 4

 

Sanofi-Synthelabo

 

Vol #:

 

1

 

 

 

EMC 5

 

Merck & Co., Inc.

 

Vol #:

 

1

 

 

 

EMC 6

 

O.W. Kone

 

Vol #:

 

1

 

 

 

EMC 7

 

Boehringer Ingelheim Pharmaceuticals, Inc.

 

Vol #:

 

1

 

 

 

2002N-0278

 

Bioterrorism; Prior Notice of Imported Food Shipments

 

 

 

 

 

EMC 113

 

Socialist Republic of Vietnam

 

Vol #:

 

14

 

 

 

EMC 114

 

Government of Australia

 

Vol #:

 

14

 

 

 

EMC 115

 

Government of Australia

 

Vol #:

 

14

 

 

 

2002P-0349

 

Amend product insert and/or label for Hemophilus Vaccines

 

 

 

PDN 1

 

FDA to Classen Immunotherapies, Inc.

 

Vol #:

 

2

 

 

 

2003D-0061

 

Comparability Protocols Chemistry Manufacturing and controls

 

 

EMC 4

 

Merck & Co., Inc.

 

Vol #:

 

1

 

 

 

2003N-0056

 

Patient Examination & Surgeons' Gloves; Test Procedures

 

 

EMC 4

 

Malaysian Rubber Glove Manufacturers' Assn (MARGMA)

 

Vol #:

 

1

 

 

 

EMC 5

 

Thai Rubber Glove Manufacturers Assn (TRGMA)

 

Vol #:

 

1

 

 

 

EMC 6

 

Lowenkamp R&D Labs, Ltd

 

Vol #:

 

1

 

 

 

EMC 7

 

Roxanne Gewalt

 

Vol #:

 

1

 

 

 

EMC 8

 

Indonesian Latex Gloves Industries Assn

 

Vol #:

 

1

 

 

 

EMC 9

 

Malaysian Rubber Export Promotion Council (MREPC)

 

Vol #:

 

1

 

 

 

EMC 10

 

Hartalega SDN.BHD

 

Vol #:

 

1

 

 

 

EMC 11

 

Andrew Lowery

 

Vol #:

 

1

 

 

 

2003N-0069

 

FDA Task Force on Consumer Health Info for Better Nutrition

 

 

EMC 10

 

HFS-22

 

Vol #:

 

1

 

 

 

EMC 11

 

Chris Crawford

 

Vol #:

 

1

 

 

 

2003N-0169

 

Dental Amalgam; Request for Information

 

 

EMC 165

 

MELISA Medica Foundation

 

Vol #:

 

3

 

 

 

EMC 166

 

Rosanne Cronin

 

Vol #:

 

3

 

 

 

EMC 167

 

Dr. Michael Lewis, DMD

 

Vol #:

 

3

 

 

 

EMC 168

 

Consumers for Dental Choice

 

Vol #:

 

3

 

 

 

EMC 169

 

No signature

 

Vol #:

 

3

 

 

 

EMC 170

 

Debbie Bevel

 

Vol #:

 

3

 

 

 

EMC 171

 

Brenda H. Nelson

 

Vol #:

 

3

 

 

 

EMC 172

 

Consumers for Dental Choice

 

Vol #:

 

3

 

 

 

EMC 173

 

Freya Koss

 

Vol #:

 

3

 

 

 

EMC 174

 

Bernard Windham

 

Vol #:

 

3

 

 

 

EMC 175

 

Bernard Windham

 

Vol #:

 

3

 

 

 

EMC 176

 

Bernard Windham

 

Vol #:

 

3

 

 

 

EMC 177

 

Consumers for Dental Choice

 

Vol #:

 

3

 

 

 

EMC 178

 

Bernard Windham

 

Vol #:

 

3

 

 

 

EMC 179

 

Consumers for Dental Choice

 

Vol #:

 

3

 

 

 

EMC 180

 

Consumers for Dental Choice

 

Vol #:

 

3

 

 

 

EMC 181

 

Consumers for Dental Choice

 

Vol #:

 

3

 

 

 

EMC 182

 

Consumers for Dental Choice

 

Vol #:

 

3

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EMC 183

 

Consumers for Dental Choice

 

Vol #:

 

3

 

 

 

EMC 184

 

Joseph Cowart

 

Vol #:

 

3

 

 

 

EMC 185

 

Bernard Windham

 

Vol #:

 

3

 

 

 

EMC 186

 

Bernard Windham

 

Vol #:

 

3

 

 

 

EMC 187

 

Sandra Duffy, JD

 

Vol #:

 

3

 

 

 

EMC 188

 

Sandra Duffy, JD

 

Vol #:

 

3

 

 

 

EMC 189

 

Sandra Duffy, JD

 

Vol #:

 

3

 

 

 

EMC 190

 

Sandra Duffy, JD

 

Vol #:

 

3

 

 

 

EMC 191

 

Sandra Duffy, JD

 

Vol #:

 

3

 

 

 

EMC 192

 

Sandra Duffy, JD

 

Vol #:

 

3

 

 

 

EMC 193

 

Sandra Duffy, JD

 

Vol #:

 

3

 

 

 

2003N-0201

 

Minimizing Medication Errors - Methods for Evaluating Proprietary Names for their Confusion Potential; Public Meeting

 

 

EMC 1

 

Orlando Veterans Healthcare Center

 

Vol #:

 

1

 

 

 

2003N-0207

 

Preparation for ICH Meetings in Brussels, Belgium, July 15-18, 2003 and ICH 6 Conference in Osaka, Japan, November 12-15, 2003

 

 

 

 

 

EMC 1

 

Helle Gawrylewski

 

Vol #:

 

1

 

 

 

2003N-0213

 

Reporting and Recordkeeping Requirements and Availability of Sample Electronic Products for Manufacturers and Distributors of Electronic Products

 

 

EMC 1

 

David R. Pacholok

 

Vol #:

 

1

 

 

 

EMC 2

 

David R. Pacholok

 

Vol #:

 

1

 

 

 

2003P-0270

 

Prohibit False and Misleading Labeling

 

 

 

 

 

 

EMC 1

 

Matthew Campbell

 

Vol #:

 

1

 

 

 

2003V-0306

 

Laser Light Show

 

 

 

 

 

 

ACK 1

 

HFA305 to Visiotopic Systems LLC

 

Vol #:

 

1

 

 

 

VAR 1

 

Visiotopic System LLC

 

Vol #:

 

1

 

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