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| Dockets Entered
On July 25, 2005
Table of Contents
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| Docket #
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| Title
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 1998C-0431
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| Synthetic Iron Oxide
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| 2002D-0492
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| Clinical Trials for Therapeutics in Adult Healthy Volunteers
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| 2005D-0155
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| Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| 2005N-0065
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| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| 2005P-0035
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| authorizing Phelon Parts, Inc., to purchase and use nitrous oxide gas as part of the manufacturing process of the Phelon Group
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| 2005P-0107
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| Glycoprotein IIb/IIIa Inhibitors - Tirofiban, Lamifiban, Eptifibatide, and Abciximab for Acute Coronary Syndromes in Women
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT
277
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| BAU, Inc
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| Vol #:
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| 214
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| RPT
278
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| U S Nutra LLC
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| Vol #:
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| 215
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| 1998C-0431
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| Synthetic Iron Oxide
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| BKG
1
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| REFERENCES
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| Vol #:
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| 1
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| NFR
1
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| FDA
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| Vol #:
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| 1
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| C 12840
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| Kofi Amankwa
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| Vol #:
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| 806
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| 2002D-0492
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| Clinical Trials for Therapeutics in Adult Healthy Volunteers
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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-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| C
3
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| Wyeth Pharmaceuticals
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| Vol #:
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| 1
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| 2005D-0155
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| Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
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| C
2
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| Methodist Healthcare Institutional Review Board
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| Vol #:
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| 1
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| C
3
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| National Community Pharmacists Assn (NCPA)
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| Vol #:
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| 1
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| C
4
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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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| C
5
Attachment
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| National Council on Patient Information and Education (NCPIE)
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| Vol #:
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| 1
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| | | | | | | | |
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| 2005N-0065
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| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
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| C
3
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| Danish Institute for Fisheries Research
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| Vol #:
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| 1
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| LET 1
Confidential
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| Pfizer, Inc.
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| Vol #:
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| 1
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| 2005P-0035
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| authorizing Phelon Parts, Inc., to purchase and use nitrous oxide gas as part of the manufacturing process of the Phelon Group
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| LET
1
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| HFD-005 to Phelon Parts, Inc.
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| Vol #:
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| 1
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| 2005P-0107
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| Glycoprotein IIb/IIIa Inhibitors - Tirofiban, Lamifiban, Eptifibatide, and Abciximab for Acute Coronary Syndromes in Women
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| C
1
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| Guilford Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| TS
1
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| King & Spalding LLP
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| Vol #:
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| 1
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