| | | | | | | | | | |
|
|
| Dockets Entered
On December 8, 2005
Table of Contents
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1976N-0052G
|
| OTC general comments & combinations
|
|
|
| 1994F-0153
|
| Safe use of n-octanol, Synthetic Fatty Alcohols
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| 2004N-0535
|
| Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request
|
|
|
| 2005D-0434
|
| Guidance for Industry and Food and Drug Administration; Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens
|
|
|
| 2005N-0186
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; State Enforcement Notifications
|
|
|
| 2005N-0354
|
| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
|
|
| 2005N-0457
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of a Claim for Generally Recognized as Safe Exemption Based on a Generally Recognized as Safe Determination
|
|
|
|
|
|
| 2005P-0048
|
| Professional labeling for aspirin dosing in order to specify the morefavorable benefit/risk profile of aspirin doses of 75-150 mg/day for secondary cardiovascular prevention, 5-=150 mg/day for seconda
|
|
|
|
| 2005P-0121
|
| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
|
|
|
| 1976N-0052G
|
| OTC general comments & combinations
|
|
|
| C
233
|
| DMD Pharmaceuticals (DMD)
|
| Vol #:
|
| 35
|
|
|
| 1994F-0153
|
| Safe use of n-octanol, Synthetic Fatty Alcohols
|
|
|
| BKG
1
|
| References 1 - 6
|
| Vol #:
|
| 2
|
|
|
| FONS
1
|
| Fonsi
|
| Vol #:
|
| 2
|
|
|
| NFR
1
|
| FDA
|
| Vol #:
|
| 2
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| SUP 1
|
| F. Kummerow
|
| Vol #:
|
| 10
|
|
|
| 2004N-0535
|
| Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request
|
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
|
|
| 2005D-0434
|
| Guidance for Industry and Food and Drug Administration; Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens
|
|
|
| GDL
1
|
| Guideline
|
| Vol #:
|
| 1
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2005N-0186
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; State Enforcement Notifications
|
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
|
|
| 2005N-0354
|
| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
|
|
| C 4
|
| M. Morrison
|
| Vol #:
|
| 4
|
|
|
| 2005N-0457
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of a Claim for Generally Recognized as Safe Exemption Based on a Generally Recognized as Safe Determination
|
|
|
|
|
|