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| Dockets Entered
On September 20, 2007
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| Docket #
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| Title
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| 2006N-0238
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| Debarment of Maria Anne Kirkman Campbell
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| 2006P-0123
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| Request that all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products
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| 2007N-0229
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Current Good Manufacturing Practice Quality System Regulations
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| 2007N-0262
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
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| 2007P-0097
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| Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
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| 2007P-0112
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| Stay the implementation of recommendations currently being provided by CDER staff to companies concerning conduct of clinical trials and proposed statistical analyses for the efficacy requirements of
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| 2007P-0352
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| FDA withdrawn the commercial marketing authorization for oral sodium phosphate (OSP) products for bowel cleansing and reclassify all OSP products for bowel cleansing as prescription only medicines
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| 2006N-0238
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| Debarment of Maria Anne Kirkman Campbell
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| LET 6
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| A. Campbell M.D.
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| Vol #:
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| 1
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| 2006P-0123
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| Request that all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products
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| LET 2
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| Federal Government
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| 1
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| 2007N-0229
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Current Good Manufacturing Practice Quality System Regulations
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| N 2
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| FDA
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| 1
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| 2007N-0262
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
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| BKG 1
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| Background Material
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| 2
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| EA 1
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| Environmental Assessment
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| 1
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| FONS 1
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| FONSI
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| 1
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| NPR 1
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| FDA
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| 1
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| 2007P-0097
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| Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
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| C 1
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| South Dakota Legislature
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| 1
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| 2007P-0112
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| Stay the implementation of recommendations currently being provided by CDER staff to companies concerning conduct of clinical trials and proposed statistical analyses for the efficacy requirements of
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| LET 1
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| Federal Government
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| 1
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| 2007P-0352
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| FDA withdrawn the commercial marketing authorization for oral sodium phosphate (OSP) products for bowel cleansing and reclassify all OSP products for bowel cleansing as prescription only medicines
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| ACK 1
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| FDA/ DDM to HellerEhrman LLP
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| 1
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| CP 1
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| HellerEhrman LLP
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| Vol #:
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| 1
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