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| Dockets Entered
On November 15, 2004
Table of Contents
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| Docket #
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| Title
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2003D-0290
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| Compounding of Drugs for Use in Animals Compliance Policy Guide
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| 2003P-0176
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| Follow-Up Approval of Therapeutic Protein Products
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| 2003P-0574
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| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| 2004D-0377
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| International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
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| 2004F-0066
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| Filing of Food Additive Petition (FAP 4A4754) Food Additives Permitted in Food on an Interim Basis or in Contact With Food Pending Additional Study; Mannitol
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| 2004P-0171
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| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
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| 2004P-0231
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| Deny approval of NDA 21-426 for Ominitrop 5.8 mg somatropin [ rDNA origin ] for injection, lyophilized powder and diluent with preservative
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| 2004P-0349
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| Action on Products containing added Mercury
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| 2004V-0505
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| Laser Light Show
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| SF
9
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| GCF-1
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| Vol #:
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| 444
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| 2003D-0290
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| Compounding of Drugs for Use in Animals Compliance Policy Guide
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| C 11
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| K and J Roach
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| Vol #:
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| 1
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| 2003P-0176
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| Follow-Up Approval of Therapeutic Protein Products
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| C
2
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| Barr Laboratories, Inc.
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| Vol #:
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| 2
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| 2003P-0574
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| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
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| C
9
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| WEBB Consulting, LLC
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| Vol #:
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| 2
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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| C
2
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| Bed Safety Consulting, Inc.
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| Vol #:
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| 1
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| 2004D-0377
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| International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
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| C
2
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| GlaxoSmithKline
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| Vol #:
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| 1
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| 2004F-0066
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| Filing of Food Additive Petition (FAP 4A4754) Food Additives Permitted in Food on an Interim Basis or in Contact With Food Pending Additional Study; Mannitol
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| BKG
1
Reference 2, 3
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| Background
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| 1
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| C
194
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| Pet Food Institute
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| Vol #:
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| 23
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| C
3
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| Amgen, Inc. (Amgen)
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| Vol #:
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| 1
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| C
4
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| Vol #:
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| 1
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| C
5
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| Sicor, Inc.
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| Vol #:
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| 1
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| C
6
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| Pfizer, Inc.
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| Vol #:
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| 1
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| 2004P-0171
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| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
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| C
5
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| Barr Laboratories, Inc.
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| Vol #:
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| 1
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| C
6
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| Vol #:
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| 1
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| 2004P-0231
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| Deny approval of NDA 21-426 for Ominitrop 5.8 mg somatropin [ rDNA origin ] for injection, lyophilized powder and diluent with preservative
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| C
2
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| Barr Laboratories, Inc.
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| Vol #:
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| 1
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| LET
1
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| HFD-005 to Morgan Lewis & Bocklus LLP
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| Vol #:
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| 1
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| 2004P-0349
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| Action on Products containing added Mercury
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| SUP
1
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| Coalition for Mercury-free Drugs (CoMeD)
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| Vol #:
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| 1
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| 2004V-0505
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| Laser Light Show
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| ACK
1
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| HFA-305 to XEFX Productions
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| Vol #:
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| 1
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| VAR
1
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| XEFX Productions
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| Vol #:
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| 1
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