| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On September 28, 2005
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1976N-0052G
|
| OTC general comments & combinations
|
|
|
|
|
| 2003N-0496
|
| Food Labeling: Health Claims; Dietary Guidance
|
|
|
|
|
| 2004N-0355
|
| Scientific Considerations Related to Developing Follow-on Protein Products
|
|
|
|
|
| 2005D-0240
|
| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
|
|
|
|
|
| 2005N-0137
|
| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
|
|
|
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
|
|
|
|
|
| 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-0402
|
| Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic-depressive illness."
|
|
|
|
|
|
|
|
|
|
|
| 1976N-0052G
|
| OTC general comments & combinations
|
|
|
|
|
| EC
1
|
| American Council on Regulatory Compliance
|
| Vol #:
|
| 35
|
|
|
|
|
| 2003N-0496
|
| Food Labeling: Health Claims; Dietary Guidance
|
|
|
|
|
| RPT
1
|
| Working Paper: Effects of Strength of Science Disclaimers on the Communication Impacts of Health Claims
|
| Vol #:
|
| 7
|
|
|
|
|
| 2004N-0355
|
| Scientific Considerations Related to Developing Follow-on Protein Products
|
|
|
|
|
| C
16
|
| Hyman, Phelps & McNamara PC
|
| Vol #:
|
| 5
|
|
| |
|
| 2005D-0240
|
| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
|
|
|
|
|
| EC
2
|
| Stony Brook University School of Dental Medicine
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0137
|
| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
|
|
|
|
|
| EC 52
|
| Mrs. Janet Adams
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 53
|
| Mrs. LeeAnn Smith
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 54
|
| Mrs. laurie zimmer
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 55
|
| Ms. Lee Vinsel
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 56
|
| Ms. Patricia Hamblin
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 57
|
| None
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 58
|
| Miss. Ercilia Campos
|
| Vol #:
|
| 3
|
|
|
|
|
| EC
59
|
| ThyCa: Thyroid Cancer Survivors' Association, Inc.
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 60
|
| Ms. vivien kao
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 61
|
| Thyroid Cancer Survivor
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 62
|
| Ms. M. Sprung
|
| Vol #:
|
| 3
|
|
|
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
|
|
|
|
|
| C 658
|
| M L Kelsey
|
| Vol #:
|
| 23
|
|
|
|
|
| C 659
|
| N Trutschnble
|
| Vol #:
|
| 23
|
|
| | | | | | | | |
|
|
|
|
| C 660
|
| M Crofutt
|
| Vol #:
|
| 23
|
|
|
|
|
| C 661
|
| B Saboski
|
| Vol #:
|
| 23
|
|
|
|
|
| 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
|
|
|
|
|
| EC 514
|
| Mrs. Bobbie Patray
|
| Vol #:
|
| 6
|
|
|
|
|
| EC 516
|
| Ms. Elise katrib
|
| Vol #:
|
| 6
|
|
|
|
|
| EC 517
|
| Mr. Justin Wax
|
| Vol #:
|
| 6
|
|
|
|
|
| EC 518
|
| Ms. Brigid Kowalczyk
|
| Vol #:
|
| 6
|
|
|
|
|
| EC 519
|
| Ms. Gwen Wilson
|
| Vol #:
|
| 6
|
|
|
|
|
| EC
520
|
| St. John Vianney Seminary
|
| Vol #:
|
| 6
|
|
|
|
|
| EC 521
|
| Mrs. Barbara Harburg
|
| Vol #:
|
| 6
|
|
|
|
|
| EC 522
|
| Ms. Elizabeth Dolinski
|
| Vol #:
|
| 6
|
|
|
|
|
| EC 523
|
| Mrs. L Petrosa
|
| Vol #:
|
| 6
|
|
|
|
|
| EC 524
|
| Dr. Daniel Goldman
|
| Vol #:
|
| 6
|
|
|
|
|
| EREG 10
|
| Michael Riley
|
| Vol #:
|
| 6
|
|
|
|
|
| EREG
11
|
| State of Maine
|
| Vol #:
|
| 6
|
|
|
|
|
| EREG 12
|
| Jane Whitwam
|
| Vol #:
|
| 6
|
|
|
|
|
| EREG 13
|
| Brenda Taylor
|
| Vol #:
|
| 6
|
|
|
|
|
| EREG
14
|
| Crisis Pregnancy Center
|
| Vol #:
|
| 6
|
|
|
|
|
| EREG 15
|
| Devon Gallagher
|
| Vol #:
|
| 6
|
|
|
|
|
| EREG 16
|
| Mother, United States Citizen
|
| Vol #:
|
| 6
|
|
|
|
|
| EREG 17
|
| None
|
| Vol #:
|
| 6
|
|
|
|
|
| 2005N-0354
|
| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
|
|
|
|
| EC 1
|
| Dr. William Davids
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0402
|
| Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic- depressive illness."
|
|
|
|
|
|
|
|
|
| ACK
1
|
| HFA-305 to Arnold & Porter
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| Ross J. Baldessarini, M.D. & Frederick K. Goodwin, M.D.
|
| Vol #:
|
| 1
|
|
