| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On December 5, 2005
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1976N-0052G
|
| OTC general comments & combinations
|
|
|
|
|
| 2001D-0044
|
| Clinical Laboratory Improvement Amendments of 1988
|
|
|
|
|
| 2004H-0322
|
| Civil Money Penalty Re: Ecumed Health Group, Inc.
|
|
|
|
|
| 2004P-0183
|
| Nutrient Content Claim: Expand Lean Definition
|
|
|
|
|
| 2004P-0452
|
| Regulate the use of coding on food labels
|
|
|
|
|
| 2005D-0330
|
| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
|
|
|
|
|
| 2005D-0340
|
| Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment
|
|
|
|
|
| 2005D-0385
|
| Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
|
|
|
|
|
| 2005N-0394
|
| FDAs Communication of Drug Safety Information; Public Hearing
|
|
|
|
|
| 2005N-0444
|
| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Dandruff Control Ingredient
|
|
|
|
|
| 2005N-0445
|
| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Acne Ingredient
|
|
|
|
|
| 2005P-0204
|
| deny the pre-market approval applications of Mentor Corporation and Inamed Corporation for approval of silicone-gel filled breast implant products
|
|
|
|
|
| 1976N-0052G
|
| OTC general comments & combinations
|
|
|
|
|
| EMC
3
|
| BDI Marketing Inc (BDI)
|
| Vol #:
|
| 35
|
|
|
|
|
| 2001D-0044
|
| Clinical Laboratory Improvement Amendments of 1988
|
|
|
|
|
| C
42
|
| Dade Behring Inc
|
| Vol #:
|
| 3
|
|
|
|
|
| C
43
|
| Focus Diagnostics
|
| Vol #:
|
| 3
|
|
|
|
|
| C 44
|
| R Ozmon
|
| Vol #:
|
| 3
|
|
|
|
|
| EC
4
|
| Alameda County Medical Center/Highland Genl Hosp
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
2
|
| Krouwer Consulting
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
3
|
| Center for Medicare & Medicaid Services, DHHS
|
| Vol #:
|
| 3
|
|
|
|
|
| 2004H-0322
|
| Civil Money Penalty Re: Ecumed Health Group, Inc.
|
|
|
|
|
| CS 18
|
| HFA-305 to Parties
|
| Vol #:
|
| 10
|
|
|
|
|
| MO 15
|
| Center for Devices and Radiological Health, Ecumed Health Group, Inc, Amador Reyes, Juan Carrai, R
|
| Vol #:
|
| 10
|
|
|
|
|
| OR 17
|
| Administrative Law Judge
|
| Vol #:
|
| 10
|
|
| |
|
| 2004P-0183
|
| Nutrient Content Claim: Expand Lean Definition
|
|
|
|
|
| BKG 1
|
| Background Information for NPR 1
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004P-0452
|
| Regulate the use of coding on food labels
|
|
|
|
|
| PDN 2
|
| HFC-1 to B Abraham
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0330
|
| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
|
|
|
|
|
| C
5
|
| Baylor Medical Center at Irving
|
| Vol #:
|
| 3
|
|
|
|
|
| EC
1
|
| Scott
|
| Vol #:
|
| 3
|
|
| | | | | | | | |
|
|
|
|
| EC
2
|
| University of Michigan
|
| Vol #:
|
| 3
|
|
|
|
|
| EC
3
|
| Heartpumper, Inc.
|
| Vol #:
|
| 3
|
|
| |
|
| 2005D-0340
|
| Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment
|
|
|
|
|
| C
1
|
| American Academy of Dermatology Association
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0385
|
| Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
|
|
| |
|
| C
3
|
| Wyeth Pharmaceuticals
|
| Vol #:
|
| 1
|
|
|
|
|
| C 4
|
| D Luce
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
4
|
| NACDS
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
5
|
| Alert Marketing, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
6
|
| Americas Blood Centers
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
7
|
| Johnson and Johnson
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
8
|
| Mr. David Luce
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
1
|
| Merck & Co Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
2
|
| Pfizer Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0394
|
| FDAs Communication of Drug Safety Information; Public Hearing
|
|
|
|
|
| EC
6
|
| Mr. Charles Carpenter
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
7
|
| Mrs. betty sicher
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0444
|
| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Dandruff Control Ingredient
|
|
|
|
|
| BKG
1
|
| Background
|
| Vol #:
|
| 1
|
|
|
|
|
| NRD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0445
|
| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Acne Ingredient
|
|
|
|
|
| BKG
1
|
| Background
|
| Vol #:
|
| 1
|
|
|
|
|
| NRD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0204
|
| deny the pre-market approval applications of Mentor Corporation and Inamed Corporation for approval of silicone-gel filled breast implant products
|
|
|
|
|
| LET
1
|
| HFZ-1 to Zuckerman Spaeder, LLP
|
| Vol #:
|
| 1
|
|
