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| Dockets Management
Dockets Entered On August 5, 2003
Table of Contents |
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| Docket #
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| Title
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| 1978N-0036L
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| OTC Laxative
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| 1989N-0106
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| Shellac and Shellac Wax
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| 1991D-0425
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| Guideline for Clinical Evaluation of Analgesic Drugs; Avail.
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutritin
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| 1998N-1109
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| Mercury Compounds in Drugs and Food
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| 2000P-1322
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| Food Labeling and Allergen Contamination Control
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| 2002D-0385
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| Approval of Labeling for Foods Treated by Irradiation
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| 2002D-0526
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| Guidance for drug Chemistry, Manufacturing, Control Info.
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| 2002N-0511
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| Proposal to Debar Thomas R. Theodore;Notice of Opportunity
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| 2003D-0112
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| Independent Consultants for Biotechnology Clinical Trias
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| 2003D-0228
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| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 1 b Reviewable Units for Fast Track Products Under PDUFA
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| 2003D-0229
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| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 b Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
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| 2003D-0236
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| Draft "Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis;" Availability
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| 2003E-0036
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| Patent Extension Application for SPECTRACEF No. 4,839,350
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| 2003N-0143
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| Continued Over-the-Counter Status of Ipecac Syrup
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| 2003P-0291
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| Enforce the law and prevent unlaw sale of contact lens
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| 2003P-0296
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| Romano Cheese for Manufacturing Deviating From Identity Standard; Temporary Permit for Market Testing
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| 1978N-0036L
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| OTC Laxative
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| NPR
9
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| FDA
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| Vol #:
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| 121
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| 1989N-0106
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| Shellac and Shellac Wax
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| C
5
Attachment
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| McKenna Long & Aldridge L.L.P.
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| Vol #:
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| 1
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| 1991D-0425
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| Guideline for Clinical Evaluation of Analgesic Drugs; Avail.
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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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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutritin
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| C
97
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| International Dairy Foods Assn (IDFA)
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| Vol #:
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| 7
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| C
98
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| National Milk Producers Federation (NMPF)
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| Vol #:
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| 7
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| 1998N-1109
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| Mercury Compounds in Drugs and Food
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| N
2
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| FDA
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| Vol #:
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| 2
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 6794
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| Mrs. Rita Flygar
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| Vol #:
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| 291
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| C 6795
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| no signature
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| Vol #:
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| 291
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| C 10000
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| Carol Anne Campbell
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| Vol #:
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| 580
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| 2000P-1322
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| Food Labeling and Allergen Contamination Control
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| C 537
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| Ms. Julia Baresch
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| Vol #:
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| 30
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| 2002D-0385
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| Approval of Labeling for Foods Treated by Irradiation
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| C
17
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| Phoenix Regulatory Associates, Ltd.
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| Vol #:
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| 1
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| 2002D-0526
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| Guidance for drug Chemistry, Manufacturing, Control Info.
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| C
16
Attachment
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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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| 2002N-0511
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| Proposal to Debar Thomas R. Theodore;Notice of Opportunity
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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-0112
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| Independent Consultants for Biotechnology Clinical Trias
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| C
2
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| Biotechnology Industry Organization (BIO)
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| Vol #:
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| 1
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| 2003D-0228
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| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 1 b Reviewable Units for Fast Track Products Under PDUFA
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| C
4
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| PhRMA
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| Vol #:
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| 1
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| 2003D-0229
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| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 b Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
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| C
4
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| PhRMA
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| Vol #:
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| 1
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| 2003D-0236
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| Draft "Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis;" Availability
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| C
3
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| Mayo Clinic
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| Vol #:
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| 1
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| 2003E-0036
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| Patent Extension Application for SPECTRACEF No. 4,839,350
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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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| 2003N-0143
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| Continued Over-the-Counter Status of Ipecac Syrup
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| C 7
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| Richard C. Dart, MD, PhD
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| Vol #:
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| 1
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