| | | | | | | | | | |
|
| |
|
| Dockets Entered
On August 9, 2006
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 2003N-0355
|
| Medical Devices; Exception from General Requirements for Informed Consent
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| 2006N-0219
|
| Clinical Trial Design Issues in the Development of Products for Treatment of Chronic Hepatitis C Infection
|
|
|
|
|
| 2006P-0151
|
| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
|
|
|
|
|
| 2006P-0209
|
| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
|
|
|
|
|
| 2006P-0223
|
| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
|
|
|
|
|
| 2006V-0317
|
| Laser Light Show
|
|
|
|
|
| 2003N-0355
|
| Medical Devices; Exception from General Requirements for Informed Consent
|
|
|
|
|
| C 1
|
| Association of Public Health Laboratories
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| C 18009
|
| M. Jackson
|
| Vol #:
|
| 194
|
|
|
|
|
| C 18010
|
| J. Styles
|
| Vol #:
|
| 194
|
|
|
|
|
| C 18011
|
| S. Griffith
|
| Vol #:
|
| 194
|
|
|
|
|
| C 18012
|
| C. Girio
|
| Vol #:
|
| 194
|
|
|
|
|
| C 18013
|
| A. Hoag
|
| Vol #:
|
| 194
|
|
|
|
|
| C 18014
|
| H. Staples
|
| Vol #:
|
| 194
|
|
|
|
|
| C 18015
|
| H. Marinac
|
| Vol #:
|
| 194
|
|
|
|
|
| EC 33259
|
| Mrs. Michelle Norton
|
| Vol #:
|
| 142
|
|
|
|
|
| EMC 3591
|
| C. Nash
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3592
|
| L. Tillinghast
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3593
|
| K. Benoure
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3594
|
| K. Zant
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3595
|
| W. Bishop
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3596
|
| T. Bishop
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3597
|
| K. Velde
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3598
|
| Dr. S. Hudson
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3599
|
| K. Henderson
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3600
|
| D. Sparks
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3601
|
| M. Tranchina
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3602
|
| M. Dudai
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3603
|
| A. Langley
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3604
|
| A. Lewis
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3605
|
| Dr. K. Kochler
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3606
|
| J. Weideman Sr.
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3607
|
| A. Lewis
|
| Vol #:
|
| 176
|
|
| | | | | | | | |
|
| |
|
| EMC 3608
|
| M. Ferguson
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3609
|
| D. Pratte
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3610
|
| C. Buchar
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3611
|
| K. Linedecker
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3612
|
| D. Bunger
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3613
|
| M. Bernardo
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3614
|
| S. Naylor
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3615
|
| A. Alvarez
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3616
|
| R. McGuckin
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3617
|
| L. Stanton
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3618
|
| N. Morris
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3619
|
| B. Schilling
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3620
|
| V. Kaas
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3621
|
| D. Detwiler
|
| Vol #:
|
| 176
|
|
|
|
|
| 2006N-0219
|
| Clinical Trial Design Issues in the Development of Products for Treatment of Chronic Hepatitis C Infection
|
|
|
|
|
| NM 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0151
|
| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
|
|
|
|
|
| C 2
|
| Public CItizen;COmmand Trust et al.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0209
|
| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
|
|
|
|
|
| C 2
|
| Valent Pharmaceuticals International (Valeant)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0223
|
| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
|
|
|
|
|
|
|
|
|
| EMC 23
|
| T. Adams
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 24
|
| C. Jackson
|
| Vol #:
|
| 2
|
|
|
|
|
| 2006V-0317
|
| Laser Light Show
|
|
|
|
|
| ACK 1
|
| FDA/ DDM to Linden Laser Systems
|
| Vol #:
|
| 1
|
|
|
|
|
| VAR 1
|
| Linden Laser Systems
|
| Vol #:
|
| 1
|
|
