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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety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