| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On August 3, 2005
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1976N-0052N
|
| OTC Nasal Decongestants
|
|
|
|
|
| 1995N-0205
|
| OTC Bronchodilator Drug Products
|
|
|
|
|
| 1997N-0484T
|
| Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
|
|
|
|
| 2004N-0279
|
| Developing DIA/FDA Workshop: Pharmacogenomic Combination Product Co-development; Public Meeting
|
|
|
|
|
| 2005D-0062
|
| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
|
|
|
|
|
| 2005D-0122
|
| Guidance for Industry on Exploratory IND Studies
|
|
|
|
|
| 2005D-0155
|
| Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
|
|
|
|
|
| 2005D-0202
|
| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
|
|
|
|
|
| 2005D-0203
|
| Guidance for Industry on Safety Testing of Drug Metabolites
|
|
|
|
|
| 2005N-0178
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act
|
|
|
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
|
|
|
|
|
| 2005P-0121
|
| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
|
|
|
|
|
| 2005P-0224
|
| To request administrative action regarding the purported weight and fat loss benefits of dairy products
|
|
|
|
|
| 2005P-0307
|
| ANDA Suitability for Warfarin Sodium Solution
|
|
|
|
|
| 2005Q-0297
|
| Qualified Health Claim (QHC): Green Tea and Reduced Risk of Cardiovascular Disease
|
|
|
|
|
| 2005V-0268
|
| Projector for a Laser Light Show
|
|
|
|
|
| 1976N-0052N
|
| OTC Nasal Decongestants
|
|
|
|
|
| C
243
|
| Bayer HealthCare, Consumer Care Division
|
| Vol #:
|
| 77
|
|
|
|
|
| 1995N-0205
|
| OTC Bronchodilator Drug Products
|
|
|
|
|
| EC 1
|
| Dr. Thomas Tiedt
|
| Vol #:
|
| 7
|
|
|
|
|
| 1997N-0484T
|
| Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling
|
|
|
|
|
| EC
1
|
| Fertility Alternatives, Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| LET
16452
|
| Purapharm International (H.K.) Limited
|
| Vol #:
|
| 147
|
|
|
|
|
| LET
16453
|
| Enzymatic Therapy
|
| Vol #:
|
| 147
|
|
|
|
|
| LET
16454
|
| Enzymatic Therapy
|
| Vol #:
|
| 147
|
|
|
|
|
| LET
16455
|
| Enzymatic Therapy
|
| Vol #:
|
| 147
|
|
|
|
|
| LET
16456
|
| Enzymatic Therapy
|
| Vol #:
|
| 147
|
|
|
|
|
| LET
16457
|
| Enzymatic Therapy
|
| Vol #:
|
| 147
|
|
|
|
|
| LET
16458
|
| Michael's Naturopathic Programs
|
| Vol #:
|
| 147
|
|
|
|
|
| LET
16459
|
| AdvoCre International, L.P.
|
| Vol #:
|
| 147
|
|
| | | | | | | | |
|
|
|
|
| LET
16460
|
| AdvoCare International, L.P.
|
| Vol #:
|
| 147
|
|
|
|
|
| LET
16461
|
| Sigma-Tau Pharmaceuticals, Inc.
|
| Vol #:
|
| 147
|
|
|
|
|
| LET
16462
|
| Enzymatic Therapy
|
| Vol #:
|
| 147
|
|
|
|
|
| LET
16463
|
| Enzymatic Therapy
|
| Vol #:
|
| 147
|
|
|
|
|
| LET
16464
|
| Miracle Breakthrough Lab, Inc.
|
| Vol #:
|
| 147
|
|
|
|
|
| LET
16465
|
| Miracle Breakthrough Lab, Inc.
|
| Vol #:
|
| 147
|
|
|
|
|
| LET
16466
|
| Miracle Breakthrough Lab, Inc.
|
| Vol #:
|
| 147
|
|
|
|
|
| LET
16467
|
| Leiner Health Products
|
| Vol #:
|
| 147
|
|
|
|
|
| LET
16468
|
| Enzymatic Therapy
|
| Vol #:
|
| 147
|
|
|
|
|
| LET
16469
|
| Enzymatic Therapy
|
| Vol #:
|
| 147
|
|
|
|
|
| LET
16470
|
| Enzymatic Therapy
|
| Vol #:
|
| 147
|
|
|
|
|
| LET
16471
|
| Enzymatic Therapy
|
| Vol #:
|
| 147
|
|
|
|
|
| LET
16472
|
| Enzymatic Therapy
|
| Vol #:
|
| 147
|
|
|
|
|
| LET
16473
|
| Enzymatic Therapy
|
| Vol #:
|
| 147
|
|
|
|
|
| LET
16474
|
| Douglas Laboratories
|
| Vol #:
|
| 147
|
|
|
|
|
| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
|
|
|
|
| EMC
1431
|
| Rohwer Technical Consulting LLC
|
| Vol #:
|
| 23
|
|
|
|
|
| 2004N-0279
|
| Developing DIA/FDA Workshop: Pharmacogenomic Combination Product Co-development; Public Meeting
|
|
|
|
|
| EC
4
|
| Johnson & Johnson
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0062
|
| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
|
|
|
|
|
| C
4
|
| Society for Women's Health Research
|
| Vol #:
|
| 1
|
|
|
|
|
| C
5
|
| AstraZeneca LP
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0122
|
| Guidance for Industry on Exploratory IND Studies
|
|
|
|
|
| C
15
|
| Washington University In St. Louis, School of Medicine
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0155
|
| Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
|
|
|
|
|
| C
4
|
| GlaxoSmithKline
|
| Vol #:
|
| 1
|
|
|
|
|
| C
5
|
| HIV Vaccine Trials Network
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0202
|
| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
|
|
|
|
|
| C
1
|
| Pfizer Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0203
|
| Guidance for Industry on Safety Testing of Drug Metabolites
|
|
|
|
|
| C
1
|
| Boehringer Ingelheim Pharmaceuticals Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| C
2
|
| Eli Lilly and Company
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
|
|
| C
3
|
| Sanofi-Synthelabo Inc, Aventis Pharmaceuticals
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0178
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act
|
|
|
|
|
| EC 1
|
| National Milk Producers Federation
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
2
|
| National Milk Producers Federation
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
|
|
|
|
|
| EC
11
|
| Mr. C.R. Schmink
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
12
|
| Mrs. Starr McGettigan
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
13
|
| My Family
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
14
|
| Mr. Tom George
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0121
|
| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
|
|
|
|
|
| LET
1
|
| HFZ-1 to RS Medical
|
| Vol #:
|
| 3
|
|
|
|
|
| 2005P-0224
|
| To request administrative action regarding the purported weight and fat loss benefits of dairy products
|
|
|
|
|
| WDL
1
|
| Physicians Committee for Responible Medicine
|
| Vol #:
|
| 2
|
|
|
|
|
| 2005P-0307
|
| ANDA Suitability for Warfarin Sodium Solution
|
|
|
| ACK
1
|
| HFA-305 to Morton Grove Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| Morton Grove Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005Q-0297
|
| Qualified Health Claim (QHC): Green Tea and Reduced Risk of Cardiovascular Disease
|
|
|
|
|
| LET
1
|
| HFS-800 to AAC Consulting Group
|
| Vol #:
|
| 5
|
|
|
|
|
| 2005V-0268
|
| Projector for a Laser Light Show
|
|
|
|
|
| VRA
1
|
| HFZ-200 to Alchemy Concert Systems Inc
|
| Vol #:
|
| 1
|
|
