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| Dockets Entered
On October 20, 2005
Table of Contents
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| Docket #
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| Title
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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| International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
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| 2004D-0378
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| International Conference on Harmonisation; Draft Guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
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| 2005D-0362
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| Guidance for Industry on Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies
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| 2005P-0423
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| Immediately add a black box warning regarding the risks of drug-induced blindness for the three phosphodiesterase 5 inhibitors that are prescribed for the treatment of erectile dysfuntion
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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| International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
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| GDL
2
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| Gu8idance
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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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| 2004D-0378
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| International Conference on Harmonisation; Draft Guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
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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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| 2005D-0362
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| Guidance for Industry on Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies
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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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| 2005P-0423
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| Immediately add a black box warning regarding the risks of drug-induced blindness for the three phosphodiesterase 5 inhibitors that are prescribed for the treatment of erectile dysfuntion
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| ACK
1
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| HFA-305 to Public Citzen's Health Research Group
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| 1
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| CP
1
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| Public Citzen's Health Research Group
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| Vol #:
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| 1
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