| | | | | | | | | | |
|
|
| Dockets Entered
On May 11, 2006
Table of Contents
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1994V-0448
|
| Variance for L75 IR Laser Sight System
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
|
|
| 2002V-0523
|
| Laser Light Show
|
|
|
| 2005N-0437
|
| Medical Gas Containers and Closures; Current Good Manufacturing
|
|
|
| 2005N-0467
|
| Medical Devices; Radiology Devices; Reclassification of Bone Sonometers
|
|
|
| 2005P-0325
|
| Request Commissioner of Food and Drugs to amend its regulations related to sugar and alternative sweeteners
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
| 2005V-0222
|
| Laser Light Show
|
|
|
| 2006D-0012
|
| Guidance for Industry and FDA Staff; Pharmacogenetic Tests and Genetic Tests for Heritable Markers
|
|
|
| 2006N-0019
|
| Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device
|
|
|
| 2006N-0045
|
| Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing (NAT); Public Workshop; Request for Comments
|
|
|
| 2006P-0147
|
| Determine whether Risperdal M Tab (Risperidone) Orally Disintegrating Tablets, 3 mg and 4 mg (NDA No. 21-444), was voluntarily withdrawn or withheld from sale for safety or efficacy reasons
|
|
|
| 2006P-0201
|
| Cefotan (cefotetan injection), equivalent 1 g base/vial and 2 g base/vial, mfged by AstraZeneca has been voluntarily withdrawn from sale for safety and efficacy reasons
|
|
|
| 2006V-0143
|
| Laser Light Show
|
|
|
| 1994V-0448
|
| Variance for L75 IR Laser Sight System
|
|
|
| VRA 4
|
| FDA/CDRH to Surefire, LLC
|
| Vol #:
|
| 1
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| LET 17582
|
| GNC
|
| Vol #:
|
| 162
|
|
|
| LET 17583
|
| Alan James Group, Inc.
|
| Vol #:
|
| 162
|
|
|
| LET 17584
|
| Miracle Breakthrough Lab, Inc.
|
| Vol #:
|
| 162
|
|
|
| LET 17585
|
| Miracle Breakthrough Lab, Inc.
|
| Vol #:
|
| 162
|
|
|
| LET 17586
|
| Anabolic Laboratories, Inc.
|
| Vol #:
|
| 162
|
|
|
| LET 17587
|
| Anabolic Laboratories, Inc.
|
| Vol #:
|
| 162
|
|
|
| LET 17588
|
| Anabolic Laboratories, Inc.
|
| Vol #:
|
| 162
|
|
|
| LET 17589
|
| Arbonne International, LLC
|
| Vol #:
|
| 162
|
|
|
| LET 17590
|
| Arbonne International, LLC
|
| Vol #:
|
| 162
|
|
|
| LET 17591
|
| Market America, Inc.
|
| Vol #:
|
| 162
|
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
|
|
| C 1386
|
| L. Chamberlain, D.O.
|
| Vol #:
|
| 259
|
|
|
| 2002V-0523
|
| Laser Light Show
|
|
|
| VRA 2
|
| FDA/CDRH to Louisiana Arts and Science Museum
|
| Vol #:
|
| 1
|
|
|
| 2005N-0437
|
| Medical Gas Containers and Closures; Current Good Manufacturing
|
|
| | | | | | | | |
|
|
| C 9031
|
| P. Chabrowe
|
| Vol #:
|
| 132
|
|
|
| C 9032
|
| D. Deckert
|
| Vol #:
|
| 132
|
|
|
| C 9033
|
| P. Boucher
|
| Vol #:
|
| 132
|
|
|
| C 9034
|
| H. L. Elsen
|
| Vol #:
|
| 132
|
|
|
| C 9035
|
| B. L. Heiser
|
| Vol #:
|
| 132
|
|
|
| C 9036
|
| L. Fisher
|
| Vol #:
|
| 132
|
|
|
| C 9037
|
| M. Humer
|
| Vol #:
|
| 132
|
|
|
| C 9038
|
| J. Jacox
|
| Vol #:
|
| 132
|
|
|
| C 9039
|
| L. J. Carter
|
| Vol #:
|
| 132
|
|
|
| C 9040
|
| B. E. Raimond
|
| Vol #:
|
| 132
|
|
|
| C 9041
|
| N. Black
|
| Vol #:
|
| 132
|
|
|
| C 9042
|
| R. Black
|
| Vol #:
|
| 132
|
|
|
| C 9043
|
| D. A. Mitchell
|
| Vol #:
|
| 132
|
|
|
| C 9044
|
| M. Carina P. Kowalewski
|
| Vol #:
|
| 132
|
|
|
| C 9045
|
| D. Ballon
|
| Vol #:
|
| 132
|
|
|
| C 9046
|
| L. Houska
|
| Vol #:
|
| 132
|
|
|
| C 9047
|
| C. Chapman
|
| Vol #:
|
| 132
|
|
|
| C 9048
|
| R. M. Shoemaker
|
| Vol #:
|
| 132
|
|
|
| C 9049
|
| J. Simpson
|
| Vol #:
|
| 132
|
|
|
| C 9050
|
| P. A. Thurau
|
| Vol #:
|
| 132
|
|
|
| 2005V-0222
|
| Laser Light Show
|
|
|
| VRA 1
|
| FDA/CDRH to Roper Mountain Science Center
|
| Vol #:
|
| 1
|
|
|
| 2006D-0012
|
| Guidance for Industry and FDA Staff; Pharmacogenetic Tests and Genetic Tests for Heritable Markers
|
|
|
| C 4
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 1
|
|
|
| 2006N-0019
|
| Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device
|
|
|
| C 8
|
| Alphatec Spine, Inc.
|
| Vol #:
|
| 2
|
|
|
| 2006N-0045
|
| Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing (NAT); Public Workshop; Request for Comments
|
|
|
| C 1
|
| R. Seidenberg
|
| Vol #:
|
| 1
|
|
|
| 2006P-0147
|
| Determine whether Risperdal M Tab (Risperidone) Orally Disintegrating Tablets, 3 mg and 4 mg (NDA No. 21-444), was voluntarily withdrawn or withheld from sale for safety or efficacy reasons
|
|
|
|
|
|
| C 1
|
| D. Lowe
|
| Vol #:
|
| 1
|
|
|
| 2006P-0201
|
| Cefotan (cefotetan injection), equivalent 1 g base/vial and 2 g base/vial, mfged by AstraZeneca has been voluntarily withdrawn from sale for safety and efficacy reasons
|
|
|
| CP 1
|
| B. Braun Medical Inc.
|
| Vol #:
|
| 1
|
|