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| Dockets Entered
On October 30, 2003
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1999N-1168
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| Public Health Impact of Foodborne Listeria Monocytogenes
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| 2000P-0586
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| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2002D-0467
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| Blood products safety cases known/suspected West Nile Virus
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| 2002N-0276
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| Bioterrorism Preparedness;Registration of Food Facilities
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| 2002N-0534
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| Medical Device User Fee and Modernization Act of 2002
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| 2003D-0165
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| Current Good Manufacturing Practices for Medical Gases
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| 2003D-0263
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| Draft Guidance for Industry: Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protecti
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| 2003D-0364
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| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Annual Reports for NDAs and ANDAs
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| 2003D-0367
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| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic FormatbHuman Pharmaceutical Applications and Related Submissions
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| 2003D-0380
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| Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability
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| 2003D-0382
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| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
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| 2003N-0211
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| Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2003P-0089
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| Loratadine in 10 Milligrams Orally Disintegrating Tablets
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| 2003P-0160
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| FDA to send letter ruling refusing to approve loratadine tab
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| 2003P-0275
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| Reclassify Cyclosporine (CSA) as Non-antibiotic Drug
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| 2003P-0321
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| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| 2003P-0501
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| Pyridostigmine Bromide Tablets, 30mg for the of myasthenia gravis (ANDA) voluntarily withdrawn from sale for safety or efficacy reasons
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| 2003Q-0401
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| Qualified Health Claim (QHC) Omega-3 Fatty Acids and Coronoary Heart Disease Health Claim
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
11402
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| Cooper, Inc.
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| Vol #:
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| 87
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| LET
11403
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 87
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| 1999N-1168
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| Public Health Impact of Foodborne Listeria Monocytogenes
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| NAD
2
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| FDA
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| Vol #:
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| 23
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| RA
1
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| Risk Assessment
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| Vol #:
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| 23
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| C 10001
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| Steven & Yasmin Myers
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| Vol #:
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| 580
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| C 10002
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| Jesse Brown et al.
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| Vol #:
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| 580
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| C 1343
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| Clay Olson
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| Vol #:
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| 233
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| C 1344
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| Jim and Virginia Wagner
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| Vol #:
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| 233
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| C 1345
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| Leland Merk
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| Vol #:
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| 233
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| C 1346
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| Virginia and Jim Wagner
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| Vol #:
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| 233
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| C 1347
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| Todd Hauser
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| Vol #:
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| 233
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| C 1348
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| Monica L. Riordan
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| Vol #:
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| 233
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| C 1349
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| Sylvia B. Haven
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| Vol #:
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| 233
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| C 1350
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| Clay Olson
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| Vol #:
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| 233
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| C 1351
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| Monica L. Riordan
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| Vol #:
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| 233
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| C 1352
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| 10 signatures
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| Vol #:
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| 233
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| C 1353
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| Jeannie Nelson
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| Vol #:
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| 233
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| 2002D-0467
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| Blood products safety cases known/suspected West Nile Virus
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| C
1
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| American Assn of Blood Banks (AABB)
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| Vol #:
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| 1
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| 2002N-0276
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| Bioterrorism Preparedness;Registration of Food Facilities
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| C
164
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| Australian Government
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| Vol #:
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| 15
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| NFR 1
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| Number not used
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| Vol #:
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| 1
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| C
232
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| Australian Government
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| Vol #:
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| 17
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| 2002N-0534
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| Medical Device User Fee and Modernization Act of 2002
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| C
37
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| Advanced Medical Technology Assn (AdvaMed)
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| Vol #:
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| 2
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| 2003D-0165
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| Current Good Manufacturing Practices for Medical Gases
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| C
26
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| Air Liquide America, LP (ALA)
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| Vol #:
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| 1
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| 2003D-0263
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| Draft Guidance for Industry: Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protecti
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2003D-0364
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| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Annual Reports for NDAs and ANDAs
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| C
1
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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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| 2003D-0367
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| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic FormatbHuman Pharmaceutical Applications and Related Submissions
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| C
2
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| Hoffman-La Roche, Inc.
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| Vol #:
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| 1
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| C
3
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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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| 2003D-0380
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| Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability
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| C
1
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| Merck KGaA
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| Vol #:
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| 1
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| C
2
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| Purdue Pharma, LP
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| Vol #:
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| 1
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| 2003D-0382
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| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
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| C
3
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| Genomic Profiling Systems, Inc.
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| Vol #:
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| 1
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| C
4
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| Bayer HealthCare, LLC
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| Vol #:
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| 1
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| 2003N-0211
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| Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma
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| C
6
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| American Red Cross
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| Vol #:
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| 1
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| C
7
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| Plasma Protein Therapeutics Assn (PPTA)
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| Vol #:
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| 1
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| C
8
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| America's Blood Centers (ABC)
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| Vol #:
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| 1
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| C
9
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| Armed Services Blood Program Office (ASBPO)
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| Vol #:
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| 1
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| C
10
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| Aventis Bio-Services
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| Vol #:
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| 1
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| C
2
Enclosure
1, 2, 3,
4, 5
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| National Oilseed Processors Assn (NOPA)
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| Vol #:
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| 1
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| C
3
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| American Feed Industry Assn (AFIA)
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| Vol #:
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| 1
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| C
4
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| Land O' Lakes Farmland Feed, LLC (LOLFL)
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| Vol #:
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| 1
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| 2003P-0089
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| Loratadine in 10 Milligrams Orally Disintegrating Tablets
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| PDN
1
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| HFD-001 to Zuckerman Spaeder, LLP
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| Vol #:
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| 1
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| 2003P-0160
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| FDA to send letter ruling refusing to approve loratadine tab
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| LET
1
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| HFD-005 to Frommer Lawrence & Haug, LLP
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| Vol #:
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| 1
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| 2003P-0275
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| Reclassify Cyclosporine (CSA) as Non-antibiotic Drug
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| CV 1
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| Declaration of Diane D-S, Tang-Liu, PhD
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| Vol #:
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| 1
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| CV 2
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| Declaration of H. Dwight Cavanagh, MD, PhD
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| Vol #:
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| 1
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| 2003P-0321
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| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
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| C
8
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| Three Rivers Pharmaceuticals LLC & Par Pharmaceutical, Inc.
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| Vol #:
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| 2
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| C
2
Attachment
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| University of Iowa
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| Vol #:
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| 1
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| 2003P-0501
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| Pyridostigmine Bromide Tablets, 30mg for the of myasthenia gravis (ANDA) voluntarily withdrawn from sale for safety or efficacy reasons
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| ACK 1
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| HFA-305 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| CP
1
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2003Q-0401
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| Qualified Health Claim (QHC) Omega-3 Fatty Acids and Coronoary Heart Disease Health Claim
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| C
1
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| Nu-Mega Ingredients Pty Ltd (Nu Mega)
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| Vol #:
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| 2
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