| | | | | | | | | | |
|
| |
|
| Dockets Entered
On October 7, 2005
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1996M-0356
|
| Approval of Prosthesis for Endourethral Prosthesis
|
|
|
|
|
| 1997P-0498
|
| Label foods & beverages containing greater than 5mg caffeine
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
|
|
| 1999P-5106
|
| Identify Sources of Natural Flavorings
|
|
|
|
|
| 2000D-1598
|
| Voluntary Labeling for Bioengineered Foods
|
|
|
|
|
| 2000N-1396
|
| Bioengineered Foods Consumed By Humans or Animals
|
|
|
|
|
| 2000P-1322
|
| Food Labeling and Allergen Contamination Control
|
|
|
|
|
| 2000P-1491
|
| Amend Definition & Standard of Identy for Parmesan Cheese
|
|
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
|
|
| 2002D-0018
|
| Race and Ethnicity Data in Clinical Trials for FDA
|
|
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
|
|
| 2002N-0273
|
| Animal Proteins Prohibited in Ruminant Feed
|
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
|
|
| 2003F-0471
|
| Filing of Food Additive Petition (FAP 3A4749)
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| 2003P-0132
|
| Part 135 FDA regulations standard of identity frozen dessert
|
|
|
|
|
| 2004N-0081
|
| BSE Risk Materials in Foods and Cosmetics
|
|
|
|
|
| 2004P-0557
|
| ANDA for a generic version of Efudex Cream(fluorouracil) cream
|
|
|
|
|
| 2005D-0106
|
| Guidance for Industry on Systemic Lupus Erythematosus Developing Drugs for Treatment
|
|
|
|
|
| 2005D-0288
|
| International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management
|
|
|
|
|
| 2005N-0137
|
| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
|
|
|
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
|
|
|
|
|
| 2005N-0329
|
| Designation of New Animal Drugs for Minor Uses or Minor Species
|
|
|
|
|
| 2005N-0345
|
| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
|
|
|
|
|
| 2005N-0354
|
| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
|
|
|
|
| 2005P-0139
|
| Withdraw approvals of certain herdwide/flockwide uses of critically and highly important antibiotics pursuant to guidance #152
|
|
|
|
|
| 2005P-0267
|
| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to counter Flagrant Violations of the law by Pharmacies Compounding Bio-Identical Hormone replaement therapy drugs that endanger public health
|
|
|
|
|
| 1996M-0356
|
| Approval of Prosthesis for Endourethral Prosthesis
|
|
|
|
|
| AAV 1
|
| Number not used
|
| Vol #:
|
| 1
|
|
| |
|
| 1997P-0498
|
| Label foods & beverages containing greater than 5mg caffeine
|
|
|
|
|
| EMC 5
|
| M Arrigo
|
| Vol #:
|
| 1
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
| | | | | | | | |
|
| |
|
| LET
16616
|
| Daiwa Health Development Inc.
|
| Vol #:
|
| 149
|
|
|
|
|
| LET
16617
|
| Anabolic Laboratories, Inc.
|
| Vol #:
|
| 149
|
|
|
|
|
| LET
16618
|
| CanPre LLC
|
| Vol #:
|
| 149
|
|
|
|
|
| LET
16619
|
| Ortho Molecular Products, Inc.
|
| Vol #:
|
| 149
|
|
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
|
|
| EMC 611
|
| K Wright
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC 612
|
| J V Lee
|
| Vol #:
|
| 24
|
|
|
|
|
| 1999P-5106
|
| Identify Sources of Natural Flavorings
|
|
|
|
|
| EMC 213
|
| R S Gladu
|
| Vol #:
|
| 3
|
|
|
|
|
| 2000D-1598
|
| Voluntary Labeling for Bioengineered Foods
|
|
|
|
|
| EMC 12024
|
| A & V Heinrichs
|
| Vol #:
|
| 574
|
|
|
|
|
| 2000N-1396
|
| Bioengineered Foods Consumed By Humans or Animals
|
|
|
|
|
| EMC 11592
|
| D Ravera
|
| Vol #:
|
| 349
|
|
|
|
|
| EMC 11593
|
| A & V Heinrichs
|
| Vol #:
|
| 349
|
|
| |
|
| 2000P-1322
|
| Food Labeling and Allergen Contamination Control
|
|
|
|
|
| EMC 615
|
| D Hoaglin
|
| Vol #:
|
| 30
|
|
|
|
|
| EMC 616
|
| S Weible
|
| Vol #:
|
| 30
|
|
|
|
|
| 2000P-1491
|
| Amend Definition & Standard of Identy for Parmesan Cheese
|
|
|
|
|
| EMC 1
|
| B Sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
|
|
| EMC 1288
|
| T Laurence
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC 1289
|
| N T Miller
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC 1290
|
| L
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC 1291
|
| S Haynes
|
| Vol #:
|
| 6
|
|
| |
|
| 2002D-0018
|
| Race and Ethnicity Data in Clinical Trials for FDA
|
|
|
|
|
| EMC 6
|
| B Sachau
|
| Vol #:
|
| 2
|
|
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
|
|
| EMC 229
|
| C A Fawer
|
| Vol #:
|
| 4
|
|
|
|
|
| 2002N-0273
|
| Animal Proteins Prohibited in Ruminant Feed
|
|
|
|
|
| EMC 14
|
| B Sachau
|
| Vol #:
|
| 14
|
|
|
|
|
| EMC 15
|
| Number not used
|
| Vol #:
|
| 14
|
|
| | | | | | | | |
|
| |
|
| EMC
1146
|
| Pfizer Inc
|
| Vol #:
|
| 15
|
|
|
|
|
| 2004P-0557
|
| ANDA for a generic version of Efudex Cream(fluorouracil) cream
|
|
|
|
|
| LET
2
|
| Valeant Pharmaceuticals International
|
| Vol #:
|
| 1
|
|
| |
|
| 2005D-0106
|
| Guidance for Industry on Systemic Lupus Erythematosus Developing Drugs for Treatment
|
|
|
|
|
| EMC 5
|
| P Raemdonck
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0288
|
| International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management
|
|
|
|
|
| C
5
|
| GlaxoSmithKline
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
1
|
| Japan Society of Pharmaceutical Machinery & Engineering
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
2
Attachment
|
| Japan Society of Pharmaceutical Machinery & Engineering
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0137
|
| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
|
|
|
|
|
| EMC 3
|
| L Georges
|
| Vol #:
|
| 3
|
|
|
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
|
|
|
|
|
| EMC 292
|
| L J Barnes
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 293
|
| K Bishop
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 294
|
| J E Meskill
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 295
|
| K White
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 296
|
| M Mansfield
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 297
|
| M Mansfield
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 298
|
| D Hoaglin
|
| Vol #:
|
| 5
|
|
|
|
|
| 2005N-0329
|
| Designation of New Animal Drugs for Minor Uses or Minor Species
|
|
|
|
|
| EMC 1
|
| B Sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 2
|
| B Sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0345
|
| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
|
|
|
|
|
| C
52
|
| Congress of the United States
|
| Vol #:
|
| 9
|
|
|
|
|
| C 53
|
| L Howard
|
| Vol #:
|
| 9
|
|
|
|
|
| C 54
|
| R L LaChance
|
| Vol #:
|
| 9
|
|
|
|
|
| C 55
|
| J & P O'Brien
|
| Vol #:
|
| 9
|
|
|
|
|
| C 56
|
| C Coppi
|
| Vol #:
|
| 9
|
|
|
|
|
| C 57
|
| C A Duran
|
| Vol #:
|
| 9
|
|
|
|
|
| C 58
|
| C Miller
|
| Vol #:
|
| 9
|
|
|
|
|
| C 59
|
| Mrs C D Dean Jr
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 166
|
| M Dalton
|
| Vol #:
|
| 3
|
|
