| | | | | | | | | | |
|
|
| Dockets Entered
On August 15, 2005
Table of Contents
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1990S-0308
|
| Generic Drug Speeches & Policy and Procedure Guides
|
|
|
| 1995N-0294
|
| Quality/fill container; common or unusual name regulations
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
| 1999F-4372
|
| National Fisheries Institute and the Louisiana Dep of Agricu
|
|
|
| 2000D-0835
|
| Conjugated Estrogens,USP-LC-MS Method for Qualitative Chemic
|
|
|
| 2000P-1443
|
| Stay against approval of Alendronate Sodium Tablets
|
|
|
| 2000P-1445
|
| Paragraph IV ANDAs/180-Day Exclusivity Purporses
|
|
|
| 2004D-0035
|
| Guidance for Industry on the Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis
|
|
|
| 2004N-0456
|
| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
|
|
|
|
| 2004Q-0097
|
| Qualified Health Claim: Calcium and various cancers
|
|
|
| 2004Q-0098
|
| Qualified Health Claim: Calcium and hypertension
|
|
|
| 2004Q-0099
|
| Qualified Health Claim: Calcium and menstrual disorders
|
|
|
| 2004Q-0102
|
| Qualified Health Claim: Calcium and Kidney/urinary stones
|
|
|
| 2005D-0103
|
| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
|
|
|
| 2005H-0271
|
| Civil Money Penalty: TMJ Implants, Inc.
|
|
|
| 2005N-0217
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Product Voluntary Reporting Program
|
|
|
| 2005N-0218
|
| FDA Vision 2006: A Conversation with the American Public
|
|
|
| 2005N-0262
|
| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
|
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
|
|
|
| 1990S-0308
|
| Generic Drug Speeches & Policy and Procedure Guides
|
|
|
| RPT
757
|
| Statistical Report - Month of July 2005
|
| Vol #:
|
| 54
|
|
|
| 1995N-0294
|
| Quality/fill container; common or unusual name regulations
|
|
|
| C
98
|
| Chocolate Manufacturers Association (CMA)
|
| Vol #:
|
| 3
|
|
|
| C
99
|
| Association for Dressings and Sauces (ADS)
|
| Vol #:
|
| 3
|
|
|
| EC
1
|
| Calorie Control Council
|
| Vol #:
|
| 3
|
|
|
| EC
2
|
| International Food Additives Council
|
| Vol #:
|
| 3
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
| C 7502
|
| L. Scinto
|
| Vol #:
|
| 319
|
|
|
| 1999F-4372
|
| National Fisheries Institute and the Louisiana Dep of Agricu
|
|
|
| NFR
1
|
| FDA
|
| Vol #:
|
| 5
|
|
|
| 2000D-0835
|
| Conjugated Estrogens,USP-LC-MS Method for Qualitative Chemic
|
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| 2000P-1443
|
| Stay against approval of Alendronate Sodium Tablets
|
|
|
| GDL
1
|
| Guidance for Industry 180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day
|
| Vol #:
|
| 1
|
|
|
| 2000P-1445
|
| Paragraph IV ANDAs/180-Day Exclusivity Purporses
|
|
|
| GDL
1
|
| Guidance for Industry 180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day
|
| Vol #:
|
| 1
|
|
|
| 2004D-0035
|
| Guidance for Industry on the Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis
|
|
|
| C
7
|
| GlaxoSmithKline (GSK)
|
| Vol #:
|
| 1
|
|
|
| 2004N-0456
|
| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
|
|
|
|
|
|
|
| C 68
|
| J. C. Wimmer
|
| Vol #:
|
| 5
|
|
|
| 2004Q-0097
|
| Qualified Health Claim: Calcium and various cancers
|
|
|
| LET
9
|
| Marine Bio Co Ltd
|
| Vol #:
|
| 15
|
|
|
| 2004Q-0098
|
| Qualified Health Claim: Calcium and hypertension
|
|
|
| LET
11
|
| Marine Bio Co Ltd
|
| Vol #:
|
| 9
|
|
|
| 2004Q-0099
|
| Qualified Health Claim: Calcium and menstrual disorders
|
|
|
| LET
9
|
| Marine Bio Co Ltd
|
| Vol #:
|
| 4
|
|
|
| 2004Q-0102
|
| Qualified Health Claim: Calcium and Kidney/urinary stones
|
|
|
| LET
9
|
| Marine Bio Co Ltd
|
| Vol #:
|
| 6
|
|
|
| 2005D-0103
|
| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
|
|
|
| C
11
|
| Quintiles Transnational Corp
|
| Vol #:
|
| 1
|
|
|
| 2005H-0271
|
| Civil Money Penalty: TMJ Implants, Inc.
|
|
|
| CS 1
|
| HFA-305
|
| Vol #:
|
| 1
|
|
|
| OR 1
|
| HF-3 to TMJ Implants, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2005N-0217
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Product Voluntary Reporting Program
|
|
|
| C
1
|
| L'Oreal USA Products, Inc.
|
| Vol #:
|
| 1
|
|
|
| EC 1
|
| L'O'real USA
|
| Vol #:
|
| 1
|
|
|
| EC 2
|
| L'Oreal USA
|
| Vol #:
|
| 1
|
|
|
| EC 3
|
| CTFA
|
| Vol #:
|
| 1
|
|
|
| 2005N-0218
|
| FDA Vision 2006: A Conversation with the American Public
|
|
|
| NM
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2005N-0262
|
| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
|
|