| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On September 7, 2005
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1995S-0158
|
| Community Disclosure of Institutional Review Boards
|
|
|
|
|
| 1995S-0316
|
| 75-Day Premarket Notifications for New Dietary Ingredients
|
|
|
|
|
| 2001D-0044
|
| Clinical Laboratory Improvement Amendments of 1988
|
|
|
|
|
| 2003D-0221
|
| Class II Special Controls Guidance Document: Endotoxin Activity Assay
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| 2004D-0333
|
| Emergency Use Authorization of Medical Products
|
|
|
|
|
| 2004N-0081
|
| BSE Risk Materials in Foods and Cosmetics
|
|
|
|
|
| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
|
|
|
|
| 2004P-0379
|
| Determine whether Penthrane inhalation has been voluntarily withdrawn from sale for safety or efficacy reasons
|
|
|
|
|
| 2005D-0122
|
| Guidance for Industry on Exploratory IND Studies
|
|
|
|
|
| 2005D-0174
|
| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
|
|
|
|
|
| 2005D-0334
|
| Guidance for Industry on the Pediatric Research Equity Act
|
|
|
|
|
| 2005M-0359
|
| P040044 - Matrix VSG System, Model MX-100
|
|
|
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
|
|
|
|
|
| 2005N-0335
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority -- 21 CFR Part 810
|
|
|
|
|
| 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
|
|
|
|
|
| 2005P-0006
|
| ANDA Suitability Petition for Bumetanide Injection, USP 10mg/40 mL
|
|
|
|
|
| 2005P-0094
|
| Remove the drug Iressa (gefitnib; AstraZeneca) from the market immediately
|
|
|
|
|
| 2005P-0095
|
| ANDA 505(b)(2) application for any generic version or other pharmaceutical alternative of Venofer(Iron sucrose injection USP
|
|
|
|
|
| 2005P-0096
|
| ANDA 77-421 Loratadine Syrup- Hives relief
|
|
|
|
|
| 2005P-0267
|
| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
|
|
|
|
|
| 2005P-0278
|
| prior notice of imports (21 CFR part 1,subpart I) and establishment and maintenance of records (21CFR Part 1,subpart J).
|
|
|
|
|
| 2005P-0322
|
| Immediately deny approval of the NDA for INCRELEX
|
|
| |
|
| 1995S-0158
|
| Community Disclosure of Institutional Review Boards
|
|
|
|
|
| SUP
43
|
| Northfield Laboratories BB IND #10719
|
| Vol #:
|
| 47
|
|
|
|
|
| 1995S-0316
|
| 75-Day Premarket Notifications for New Dietary Ingredients
|
|
|
|
|
| RPT
285
|
| Shannon Minerals Inc
|
| Vol #:
|
| 223
|
|
|
|
|
| RPT
286
|
| Shannon Minerals Inc
|
| Vol #:
|
| 224
|
|
|
|
|
| RPT
287
|
| Shannon Minerals Inc
|
| Vol #:
|
| 225
|
|
|
|
|
| RPT
288
|
| Shannon Minerals Inc
|
| Vol #:
|
| 226
|
|
|
|
|
| 2001D-0044
|
| Clinical Laboratory Improvement Amendments of 1988
|
|
|
|
|
| GDL
2
|
| Guidance
|
| Vol #:
|
| 3
|
|
|
|
|
| NAD
2
|
| FDA
|
| Vol #:
|
| 3
|
|
| |
|
| 2003D-0221
|
| Class II Special Controls Guidance Document: Endotoxin Activity Assay
|
|
| | | | | | | | |
|
| |
|
| EMC 1016
|
| S Peterfreund
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 1017
|
| C Fox
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 1018
|
| J Thompson
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 1019
|
| L Goldklang
|
| Vol #:
|
| 11
|
|
|
|
|
| 2004D-0333
|
| Emergency Use Authorization of Medical Products
|
|
|
|
|
| C
3
|
| U. S. Consumer Products Safety Commission
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0081
|
| BSE Risk Materials in Foods and Cosmetics
|
|
|
|
|
| ANS
1
|
| HFW-1 to Hon. Jon S. Corzine, United States Senate
|
| Vol #:
|
| 13
|
|
|
|
|
| ANS
2
|
| HFW-1 to Hon. Frank R Lautenberg, United States Senate
|
| Vol #:
|
| 13
|
|
|
|
|
| BKG
2
References
|
| Background Material
|
| Vol #:
|
| 16
|
|
|
|
|
| C
148
|
| United States Senate
|
| Vol #:
|
| 13
|
|
|
|
|
| C
149
|
| United States Senate
|
| Vol #:
|
| 13
|
|
|
|
|
| NFR
1
|
| FDA
|
| Vol #:
|
| 13
|
|
|
|
|
| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
|
|
|
|
| ANS
1
|
| HFW-1 to Hon Jon S Corzine, United States Senate
|
| Vol #:
|
| 23
|
|
|
|
|
| ANS
2
|
| HFW-1 to Hon Frank R Lautenberg, United States Senate
|
| Vol #:
|
| 23
|
|
|
|
|
| C
207
|
| United States Senate
|
| Vol #:
|
| 23
|
|
|
|
|
| C
208
|
| United States Senate
|
| Vol #:
|
| 23
|
|
|
|
|
| 2004P-0379
|
| Determine whether Penthrane inhalation has been voluntarily withdrawn from sale for safety or efficacy reasons
|
|
|
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0122
|
| Guidance for Industry on Exploratory IND Studies
|
|
|
|
|
| C
17
|
| Novo Nordisk Inc
|
| Vol #:
|
| 1
|
|
| |
|
| 2005D-0174
|
| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
|
|
|
|
|
| C
6
|
| Ohio Department of Mental Health, Office of Support Services
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0334
|
| Guidance for Industry on the Pediatric Research Equity Act
|
|
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005M-0359
|
| P040044 - Matrix VSG System, Model MX-100
|
|
|
|
|
| AAV
1
|
| AccessClosure, Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
|
|
|
|
|
| EMC
166
|
| University of Pittsburgh Drug Information center
|
| Vol #:
|
| 5
|
|
| | | | | | | | |
|
| |
|
| AMD
1
|
| Boehringer Ingelheim Ben Venue Laboratories
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0094
|
| Remove the drug Iressa (gefitnib; AstraZeneca) from the market immediately
|
|
|
|
|
| LET
1
|
| HFD-5 to Public Citizen Health Research Group
|
| Vol #:
|
| 1
|
|
| |
|
| 2005P-0095
|
| ANDA 505(b)(2) application for any generic version or other pharmaceutical alternative of Venofer(Iron sucrose injection USP
|
|
|
|
|
| LET
2
|
| HFD-5 to Luitpold Pharmaceuticals Inc
|
| Vol #:
|
| 2
|
|
|
|
|
| 2005P-0096
|
| ANDA 77-421 Loratadine Syrup- Hives relief
|
|
|
|
|
| LET
1
|
| HFD-5 to Silarx Pharmaceuticals Inc
|
| Vol #:
|
| 2
|
|
|
|
|
| 2005P-0267
|
| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
|
|
|
|
|
| C 19
|
| A. Hong Chan
|
| Vol #:
|
| 9
|
|
|
|
|
| 2005P-0278
|
| prior notice of imports (21 CFR part 1,subpart I) and establishment and maintenance of records (21CFR Part 1,subpart J).
|
|
|
|
|
| C
1
|
| International Foodservice Distributors Association (IFDA)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0322
|
| Immediately deny approval of the NDA for INCRELEX
|
|
|
|
|
| PDN
1
|
| HFD-1 to Insmed Incorporated
|
| Vol #:
|
| 3
|
|
