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| Dockets Entered
On September 7, 2005
Table of Contents
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| Docket #
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| Title
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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| 2003D-0221
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| Class II Special Controls Guidance Document: Endotoxin Activity Assay
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2004D-0333
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| Emergency Use Authorization of Medical Products
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| 2004P-0379
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| Determine whether Penthrane inhalation has been voluntarily withdrawn from sale for safety or efficacy reasons
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| 2005D-0174
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| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
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| 2005D-0334
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| Guidance for Industry on the Pediatric Research Equity Act
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| 2005M-0359
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| P040044 - Matrix VSG System, Model MX-100
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| 2005N-0335
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority -- 21 CFR Part 810
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| 2005N-0345
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| 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
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| 2005P-0006
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| ANDA Suitability Petition for Bumetanide Injection, USP 10mg/40 mL
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| 2005P-0094
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| Remove the drug Iressa (gefitnib; AstraZeneca) from the market immediately
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| 2005P-0095
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| ANDA 505(b)(2) application for any generic version or other pharmaceutical alternative of Venofer(Iron sucrose injection USP
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| 2005P-0096
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| ANDA 77-421 Loratadine Syrup- Hives relief
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| 2005P-0278
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| prior notice of imports (21 CFR part 1,subpart I) and establishment and maintenance of records (21CFR Part 1,subpart J).
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| 2005P-0322
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| Immediately deny approval of the NDA for INCRELEX
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| SUP
43
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| Northfield Laboratories BB IND #10719
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| Vol #:
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| 47
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT
285
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| Shannon Minerals Inc
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| Vol #:
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| 223
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| RPT
286
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| Shannon Minerals Inc
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| Vol #:
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| 224
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| RPT
287
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| Shannon Minerals Inc
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| Vol #:
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| 225
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| RPT
288
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| Shannon Minerals Inc
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| Vol #:
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| 226
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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| GDL
2
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| Guidance
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| Vol #:
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| 3
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| NAD
2
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| FDA
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| Vol #:
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| 3
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| 2003D-0221
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| Class II Special Controls Guidance Document: Endotoxin Activity Assay
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| EMC 1016
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| S Peterfreund
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| Vol #:
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| 11
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| EMC 1017
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| C Fox
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| Vol #:
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| 11
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| EMC 1018
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| J Thompson
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| Vol #:
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| 11
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| EMC 1019
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| L Goldklang
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| Vol #:
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| 11
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| 2004D-0333
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| Emergency Use Authorization of Medical Products
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| C
3
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| U. S. Consumer Products Safety Commission
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| Vol #:
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| 1
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| ANS
1
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| HFW-1 to Hon. Jon S. Corzine, United States Senate
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| Vol #:
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| 13
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| ANS
2
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| HFW-1 to Hon. Frank R Lautenberg, United States Senate
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| Vol #:
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| 13
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| BKG
2
References
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| Background Material
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| Vol #:
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| 16
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| C
148
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| United States Senate
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| Vol #:
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| 13
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| C
149
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| United States Senate
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| Vol #:
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| 13
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| NFR
1
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| FDA
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| Vol #:
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| 13
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| ANS
1
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| HFW-1 to Hon Jon S Corzine, United States Senate
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| Vol #:
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| 23
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| ANS
2
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| HFW-1 to Hon Frank R Lautenberg, United States Senate
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| Vol #:
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| 23
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| C
207
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| United States Senate
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| Vol #:
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| 23
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| C
208
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| United States Senate
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| Vol #:
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| 23
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| 2004P-0379
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| Determine whether Penthrane inhalation has been voluntarily withdrawn from sale for safety or efficacy reasons
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| C
17
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| Novo Nordisk Inc
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| Vol #:
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| 1
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| 2005D-0174
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| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
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| C
6
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| Ohio Department of Mental Health, Office of Support Services
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| Vol #:
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| 1
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| 2005D-0334
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| Guidance for Industry on the Pediatric Research Equity Act
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| GDL
1
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| Guidance
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2005M-0359
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| P040044 - Matrix VSG System, Model MX-100
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| AAV
1
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| AccessClosure, Inc
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| Vol #:
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| 1
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| EMC
166
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| University of Pittsburgh Drug Information center
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| Vol #:
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| 5
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| AMD
1
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| Boehringer Ingelheim Ben Venue Laboratories
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| Vol #:
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| 1
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| 2005P-0094
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| Remove the drug Iressa (gefitnib; AstraZeneca) from the market immediately
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| LET
1
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| HFD-5 to Public Citizen Health Research Group
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| Vol #:
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| 1
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| 2005P-0095
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| ANDA 505(b)(2) application for any generic version or other pharmaceutical alternative of Venofer(Iron sucrose injection USP
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| LET
2
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| HFD-5 to Luitpold Pharmaceuticals Inc
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| Vol #:
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| 2
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| 2005P-0096
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| ANDA 77-421 Loratadine Syrup- Hives relief
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| LET
1
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| HFD-5 to Silarx Pharmaceuticals Inc
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| Vol #:
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| 2
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| C 19
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| A. Hong Chan
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| Vol #:
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| 9
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| 2005P-0278
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| prior notice of imports (21 CFR part 1,subpart I) and establishment and maintenance of records (21CFR Part 1,subpart J).
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| C
1
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| International Foodservice Distributors Association (IFDA)
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| Vol #:
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| 1
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| 2005P-0322
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| Immediately deny approval of the NDA for INCRELEX
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| PDN
1
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| HFD-1 to Insmed Incorporated
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| Vol #:
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| 3
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