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| Dockets Entered
On September 22, 2003
Table of Contents
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| Docket #
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| Title
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| 2003D-0060
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| Part11, Electronic records, electronic signatures scope
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| 2003D-0163
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| Blood Product Safety in Cases of Suspected SARS,Severe Acute
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| 2003D-0379
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| Draft Guidance for Industry on Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition; Availability
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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| Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability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| Draft Guidance for Industry on Sterile Drug Products Produced by Aseptic Processing
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| 2003D-0385
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| Guidance for Industry: Comparability Protocols b
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| 2003D-0386
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| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| 2003V-0435
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| Laser Light Show
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| 2003D-0060
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| Part11, Electronic records, electronic signatures scope
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| GDL
2
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| Final Guidance
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| 2003D-0163
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| Blood Product Safety in Cases of Suspected SARS,Severe Acute
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| GDL
2
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| Guidance
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| 2003D-0379
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| Draft Guidance for Industry on Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition; Availability
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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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| 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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|
|
|
|
| GDL
1
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| Draft 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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| 2003D-0382
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| Draft Guidance for Industry on Sterile Drug Products Produced by Aseptic Processing
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|
|
|
|
| GDL
1
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| Draft 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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| 2003D-0385
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| Guidance for Industry: Comparability Protocols b
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| GDL
1
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| Draft 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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| 2003D-0386
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| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
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|
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| GDL
1
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| Draft 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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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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