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| Dockets Entered
On October 24, 2005
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 1999P-0033
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| Combat the spread of transmissible spongiform encephalopathy
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2002D-0018
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| Race and Ethnicity Data in Clinical Trials for FDA
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| 2004N-0439
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| Current Good Manufacturing Practice for Positron Emission Tomography Drugs
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| 2004P-0452
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| Regulate the use of coding on food labels
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| 2004Q-0102
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| Qualified Health Claim: Calcium and Kidney/urinary stones
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| 2005D-0195
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| Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9
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| 2005D-0240
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| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
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| 2005D-0310
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| Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events
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| 2005D-0324
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| International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries
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| 2005N-0311
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| Critical Path Initiative; Developing Prevention Therapies; Planning of Workshop
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| 2005N-0349
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| FDA Survey of Current Manufacturing Practices in the Food Industry
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| 2005P-0116
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| To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
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| 2005P-0139
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| Withdraw approvals of certain herdwide/flockwide uses of critically and highly important antibiotics pursuant to guidance #152
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| 2005P-0429
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| re-evaluate the prescribing info/package insert for new tramadol and tramadol as schedule III drugs under the Controlled Substances Act of 1970 as amended
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16680
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| Enzymatic Therapy
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| Vol #:
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| 149
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| LET
16681
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| New Chapter, Inc.
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| Vol #:
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| 150
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| EMC 4382
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| Jana
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| Vol #:
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| 320
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| EMC 4383
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| J. Miller
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| Vol #:
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| 320
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| EMC 4384
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| D. Elliott
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| Vol #:
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| 320
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| EMC 4385
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| M. Gaudry
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| Vol #:
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| 320
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| EMC 4386
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| C. Abbate
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| Vol #:
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| 320
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| EMC 543
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| Mission Possible International
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| Vol #:
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| 8
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| EMC
544
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| Calorie Control Council
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| Vol #:
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| 8
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 1139
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| No signature
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| Vol #:
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| 11
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| EMC 1140
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| No signature
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| Vol #:
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| 11
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| EMC 1141
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| J. Casey
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| Vol #:
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| 11
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| EMC 1142
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| J. Casey
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| Vol #:
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| 11
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| EMC 1143
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| K. Lasko
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| Vol #:
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| 11
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| C 46
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| L. Schwarz
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| Vol #:
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| 5
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| C 47
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| M. Schwarz
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| Vol #:
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| 5
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| 2004N-0439
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| Current Good Manufacturing Practice for Positron Emission Tomography Drugs
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| C
1
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| North Shore/LIJ Research Institute
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| Vol #:
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| 1
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| 2004P-0452
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| Regulate the use of coding on food labels
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| LET 2
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| HFS-822 to Bunny Abraham
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| Vol #:
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| 1
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| 2004Q-0102
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| Qualified Health Claim: Calcium and Kidney/urinary stones
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| PDN
1
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| HFS-800 to Emord & Associates P.C.
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| Vol #:
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| 7
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| 2005D-0195
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| Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9
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| EMC
1
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| National Electrical Manufacturers Association (NEMA)
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| Vol #:
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| 1
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| 2005D-0240
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| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
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| C 4
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| Dr. D. Kinane, BDS,PhD,FDS,RCPS,FDS RCS
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| Vol #:
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| 1
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| 2005D-0310
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| Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events
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| C
1
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| Stanford University
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| Vol #:
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| 1
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| 2005D-0324
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| International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries
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| EMC
1
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| Abbott Laboratories (Abbott)
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| Vol #:
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| 1
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| 2005N-0311
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| Critical Path Initiative; Developing Prevention Therapies; Planning of Workshop
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| C
1
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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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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| C 113
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| M. Henning
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| Vol #:
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| 14
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| C 114
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| J. Clark, M.D., FACOG
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| Vol #:
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| 14
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| EMC 199
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| B. VanDyke
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| Vol #:
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| 3
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| EMC 200
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| P. Burstadt
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| Vol #:
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| 3
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| EMC 201
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| R. Dolislager
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| Vol #:
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| 3
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| EMC 202
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| S. Johnson
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| Vol #:
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| 3
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| 2005N-0349
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| FDA Survey of Current Manufacturing Practices in the Food Industry
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| C
1
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| Food Products Association (FPA)
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| Vol #:
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| 1
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| 2005P-0116
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| To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
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| C 4
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| B. Bouts, R.Ph., M.D., F.A.C.P.
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| Vol #:
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| 2
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| EMC 7
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| K. Mullin
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| Vol #:
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| 2
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| 2005P-0139
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| Withdraw approvals of certain herdwide/flockwide uses of critically and highly important antibiotics pursuant to guidance #152
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| EMC 768
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| M. Feldman
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| Vol #:
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| 3
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| C
33
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| American Society of Anesthesiologists (ASA)
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| Vol #:
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| 13
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| 2005P-0429
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| re-evaluate the prescribing info/package insert for new tramadol and tramadol as schedule III drugs under the Controlled Substances Act of 1970 as amended
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| ACK
1
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| HFA-305 to Dr. Najib Babul
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| Vol #:
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| 1
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| CP
1
References
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| Cinergen
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| Vol #:
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| 1
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