| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On January 23, 2007
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1976N-0052N
|
| OTC Nasal Decongestants
|
|
|
|
|
| 1978N-0065
|
| Skin Bleaching Drug Products
|
|
|
|
|
| 1981N-0022
|
| OTC Weight Control Drug Products for Human Use
|
|
|
|
|
| 2000D-1598
|
| Voluntary Labeling for Bioengineered Foods
|
|
|
|
|
| 2000N-1396
|
| Bioengineered Foods Consumed By Humans or Animals
|
|
|
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
|
|
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
|
|
|
|
| 2005N-0403
|
| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
|
|
|
|
|
| 2005P-0432
|
| Ban all Non-medical Uses of the Antibacterial Agent Triclosan
|
|
|
|
|
| 2006N-0061
|
| Charging for Investigational Drugs
|
|
|
|
|
| 2006N-0062
|
| Expanded Access to Investigational Drugs for Treatment Use
|
|
|
|
|
| 2006P-0290
|
| Risk Management Program for Fentanyl Products
|
|
|
|
|
| 2006P-0291
|
| Determine whether Eloxatin (Oxaliplatin) has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
|
|
|
|
|
| 2006P-0298
|
| To permit an ANDA Suitability for Eloxatin (Oxaliplatin for injection)
|
|
|
|
|
| 2006P-0299
|
| Determine whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons
|
|
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
|
|
| 2007P-0033
|
| Amend the Nutrition Facts label on food products as it relates to trans fats.
|
|
| |
|
| 1976N-0052N
|
| OTC Nasal Decongestants
|
|
|
|
|
| LET 124
|
| Nelson Mullins Riley & Scarborough, LLP
|
| Vol #:
|
| 86
|
|
|
|
|
| 1978N-0065
|
| Skin Bleaching Drug Products
|
|
|
|
|
| C 79
|
| Women's Dermatologic Society
|
| Vol #:
|
| 20
|
|
|
|
|
| 1981N-0022
|
| OTC Weight Control Drug Products for Human Use
|
|
|
|
|
| LET 118
|
| Nelson Mullins Riley & Scarborough, LLP
|
| Vol #:
|
| 98
|
|
|
|
|
| 2000D-1598
|
| Voluntary Labeling for Bioengineered Foods
|
|
|
|
|
| C 10016
|
| L. Jacaruso
|
| Vol #:
|
| 580
|
|
|
|
|
| 2000N-1396
|
| Bioengineered Foods Consumed By Humans or Animals
| |
|
|
|
| C 9619
|
| L. Jacaruso
|
| Vol #:
|
| 415
|
|
|
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
|
|
|
|
| C 89
|
| G and G Placas
|
| Vol #:
|
| 9
|
|
|
|
|
| C 90
|
| M. Dubrey
|
| Vol #:
|
| 9
|
|
|
|
|
| C 91
|
| S. Moore
|
| Vol #:
|
| 9
|
|
|
|
|
| C 92
|
| W. Cordain
|
| Vol #:
|
| 9
|
|
| | | | | | | | |
|
| |
|
| C 93
|
| P. Budell
|
| Vol #:
|
| 9
|
|
|
|
|
| C 94
|
| A. Felix
|
| Vol #:
|
| 9
|
|
|
|
|
| C 95
|
| Integrative Medicine of Miami-Dade & Trinidad
|
| Vol #:
|
| 9
|
|
|
|
|
| C 96
|
| K. Cook
|
| Vol #:
|
| 9
|
|
|
|
|
| C 97
|
| S. Strauss
|
| Vol #:
|
| 9
|
|
|
|
|
| C 98
|
| J. Couch
|
| Vol #:
|
| 9
|
|
|
|
|
| C 99
|
| G. Philbrick
|
| Vol #:
|
| 9
|
|
|
|
|
| C 100
|
| S. Philbrick
|
| Vol #:
|
| 9
|
|
|
|
|
| C 101
|
| L. Brack
|
| Vol #:
|
| 9
|
|
|
|
|
| C 102
|
| S. Lesniak
|
| Vol #:
|
| 9
|
|
|
|
|
| C 103
|
| G and J Hoffmann
|
| Vol #:
|
| 9
|
|
|
|
|
| C 104
|
| L. Miller
|
| Vol #:
|
| 9
|
|
|
|
|
| C 105
|
| A. Hollier
|
| Vol #:
|
| 9
|
|
|
|
|
| C 106
|
| R. Wakefield
|
| Vol #:
|
| 9
|
|
|
|
|
| C 107
|
| G and W Hatcher
|
| Vol #:
|
| 9
|
|
|
|
|
| C 108
|
| J and B Geiger
|
| Vol #:
|
| 9
|
|
|
|
|
| C 109
|
| M. Vischer
|
| Vol #:
|
| 9
|
|
|
|
|
| C 110
|
| P. Mahnke
|
| Vol #:
|
| 9
|
|
|
|
|
| C 111
|
| V. Henderson
|
| Vol #:
|
| 9
|
|
| |
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
|
|
|
|
| C 667
|
| Celiac Sprue Association
|
| Vol #:
|
| 23
|
|
|
|
|
| C 668
|
| National Foundation for Celiac Awareness (NFCA)
|
| Vol #:
|
| 23
|
|
|
|
|
| CR 1
|
| National Foundation for Celiac Awareness (NFCA)
|
| Vol #:
|
| 23
|
|
|
|
|
| NPR 1
|
| FDA
|
| Vol #:
|
| 23
|
|
|
|
|
| 2005N-0403
|
| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
|
|
|
|
|
|
|
|
|
| C 23
|
| Sanofi-aventis US, LLC
|
| Vol #:
|
| 3
|
|
|
|
|
| C 24
|
| Cleveland Clinic Foundation
|
| Vol #:
|
| 3
|
|
|
|
|
| C 25
|
| Prest-O-Sales & Service, Inc.
|
| Vol #:
|
| 3
|
|
|
|
|
| C 26
|
| PharMEDium Services
|
| Vol #:
|
| 3
|
|
|
|
|
| C 27
|
| Cryogas
|
| Vol #:
|
| 3
|
|
|
|
|
| C 28
|
| Compressed Gas Association (CGA)
|
| Vol #:
|
| 3
|
|
| |
|
| 2005P-0432
|
| Ban all Non-medical Uses of the Antibacterial Agent Triclosan
|
|
|
|
|
| LET 2
|
| FDA/CDEr to Beyond Pesticides
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0061
|
| Charging for Investigational Drugs
|
|
| | | | | | | | |
|
| |
|
| C 2
|
| National Organization for Rare Disorders, Inc. (NORD)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0062
|
| Expanded Access to Investigational Drugs for Treatment Use
|
|
|
|
|
| C 4
|
| National Organization for Rare Disorders, Inc. (NORD)
|
| Vol #:
|
| 1
|
|
| |
|
| 2006P-0290
|
| Risk Management Program for Fentanyl Products
|
|
|
|
|
| LET 1
|
| FDA/CDER to Mylan Laboratories Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0291
|
| Determine whether Eloxatin (Oxaliplatin) has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
|
|
|
|
|
| LET 1
|
| FDA/CDER to Sicor Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0298
|
| To permit an ANDA Suitability for Eloxatin (Oxaliplatin for injection)
|
|
|
|
|
| LET 1
|
| FDA/CDER to AAC Consulting Group
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0299
|
| Determine whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons
|
|
|
|
|
| LET 1
|
| FDA/CDER to Rothwell, Figg, Ernst & Manbeck, P.C.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
|
|
| C 24
|
| Rose Acre Farms
|
| Vol #:
|
| 6
|
|
|
|
|
| C 25
|
| R. Downing
|
| Vol #:
|
| 6
|
|
|
|
|
| C 26
|
| CCF Brands
|
| Vol #:
|
| 6
|
|
| |
|
| 2007P-0033
|
| Amend the Nutrition Facts label on food products as it relates to trans fats.
|
|
|
|
|
| ACK 1
|
| DDM/FDA to Ellen M. Ashworth
|
| Vol #:
|
| 1
|
|
|
|
|
| CP 1
|
| Ellen M. Ashworth
|
| Vol #:
|
| 1
|
|
