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| Dockets Entered
On February 10, 2004
Table of Contents
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| Docket #
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| Title
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| 1995P-0099
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| Permit term Polyols in Lieu of Sugar Alcohols on Food Label
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
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| 1996P-0143
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| Amend food labeling regs to permit removal of ingredients of
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| 1997P-0056
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| Caloric value not more than two per gram for soluble fiber
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998D-1146
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| Microbial effects of antimicrobial new animal drugs/human sa
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1999F-4372
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| National Fisheries Institute and the Louisiana Dep of Agricu
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| 1999F-5321
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| Food Safety & Inspection service safe use of ionizing radiai
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| 1999F-5322
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| Ionizing Radiation for the Treatment of Food
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| 1999F-5522
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| Ionizing radiation /control of Food-borne pathogens safe use
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| 1999P-4613
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| Revoke the Regulation That Approved Posilac
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| 2000P-0685
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| Revise of Yogurt Standards
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| 2001F-0047
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| Foodborne pathogens in raw-frozen-cooked-partially cooked
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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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-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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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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| 2003N-0338
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| Obesity
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| 2003N-0341
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| Requirements for Submission of In Vivo Bioequivalence Data
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| 2003N-0482
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Mammography Facilities, Standards, and Lay Summaries for Patients
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| 2003N-0496
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| Food Labeling: Health Claims; Dietary Guidance
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| 2003P-0274
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| In re Tier 1 initial Approval Program
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| 2003P-0321
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| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| 2003P-0363
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| Professional and Patient Labeling for Hearing Aid Devices
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| 2003P-0387
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| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
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| 2003P-0438
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| change the regulatory status of prenatal listening devices commonly called 'Doppler Fetoscopes' under 21 CFR 5.10
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| 2003P-0479
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| Allow importation of Canadian versions of drugs that are approved to the United States
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| | | | | | | | |
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| EMC 1211
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| G. Case
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| Vol #:
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| 377
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| EMC 1212
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| G. Case
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| Vol #:
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| 377
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| EMC 1213
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| B. Davis
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| Vol #:
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| 377
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| EMC 1214
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| M. Tice
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| Vol #:
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| 377
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| EMC 1215
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| C. Murray
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| Vol #:
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| 377
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| EMC 1216
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| R. Polanowski
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| Vol #:
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| 377
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| 1995P-0099
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| Permit term Polyols in Lieu of Sugar Alcohols on Food Label
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| EMC
1
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| Calorie Control Council
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| Vol #:
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| 1
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
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| EMC
261
Attachment
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| American Herbal Products Assn, Council for Responsible Nutrition and National Nutritional Foods Ass
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| Vol #:
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| 41
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| 1996P-0143
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| Amend food labeling regs to permit removal of ingredients of
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| EMC
1
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| Calorie Control Council
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| Vol #:
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| 1
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| 1997P-0056
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| Caloric value not more than two per gram for soluble fiber
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| EMC
1
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| Calorie Control Council
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| Vol #:
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| 2
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
12633
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12634
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12635
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12636
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 103
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| LET
12637
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 103
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| LET
12638
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 103
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| LET
12639
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| MuscleTech Research and Development, Inc.
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| Vol #:
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| 103
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| LET
12640
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12641
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12642
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12643
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12644
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12645
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12646
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12647
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12648
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12649
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| NBTY Inc.
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| Vol #:
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| 103
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| 1998D-1146
|
| Microbial effects of antimicrobial new animal drugs/human sa
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|
| | | | | | | | |
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| EMC
29
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| International Dairy Foods Assn (IDFA)
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| Vol #:
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| 2
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| EMC
30
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| Dairy & Food Culture Technologies
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| Vol #:
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| 2
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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|
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|
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| EMC 5769
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| Mike Lenkowski
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| Vol #:
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| 789
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| EMC 5770
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| Benjamin Carl
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| Vol #:
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| 789
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| EMC 5771
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| Benjamin Carl
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| Vol #:
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| 789
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| EMC 5772
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| Tigre Lusardi
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| Vol #:
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| 789
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| 2001F-0047
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| Foodborne pathogens in raw-frozen-cooked-partially cooked
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| EMC 467
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| R. Thurstin
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| Vol #:
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| 8
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| EMC 468
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| D. Lozier
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| Vol #:
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| 8
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| EMC 2946
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| J. Schmitt
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| Vol #:
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| 130
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| EMC 2947
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| D. Myers
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| Vol #:
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| 130
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| EMC 3155
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| H. Stucky
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| Vol #:
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| 252
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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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| EMC 1217
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| L. Kelly
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| Vol #:
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| 5
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| EMC 146
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| A. Adams
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| Vol #:
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| 3
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 309
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| Dr. B. Martini
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| Vol #:
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| 6
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| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 129
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| D. Tanner
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| Vol #:
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| 3
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| EMC 130
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| C. Rye
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| Vol #:
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| 3
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| EMC 131
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| No signature
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| Vol #:
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| 3
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| EMC 132
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| K. Grube
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| Vol #:
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| 3
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| EMC 133
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| M. Vanderville
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| Vol #:
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| 3
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| EMC 134
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| I. Walker, MD
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| Vol #:
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| 3
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|
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| 2003N-0338
|
| Obesity
|
|
|
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| EMC
51
|
| Calorie Control Council
|
| Vol #:
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| 10
|
|
|
|
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| 2003N-0341
|
| Requirements for Submission of In Vivo Bioequivalence Data
|
|
| | | | | | | | |
|
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|
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| EMC
2
|
| Hogan & Hartson, LLP
|
| Vol #:
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| 1
|
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| 2003N-0482
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Mammography Facilities, Standards, and Lay Summaries for Patients
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|
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| N
2
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| FDA
|
| Vol #:
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| 1
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|
|
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| 2003N-0496
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| Food Labeling: Health Claims; Dietary Guidance
|
|
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|
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| EMC 6
|
| M. Weeks
|
| Vol #:
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| 6
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|
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| 2003P-0274
|
| In re Tier 1 initial Approval Program
|
|
|
|
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| EMC 38
|
| P. McMahon
|
| Vol #:
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| 4
|
|
|
|
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| 2003P-0321
|
| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
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|
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|
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| EMC 84
|
| A. Thornburg
|
| Vol #:
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| 3
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| EMC 85
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| J. Lynch
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| Vol #:
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| 3
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| EMC 86
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| No signature
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| Vol #:
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| 3
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| EMC 87
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| No signature
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| Vol #:
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| 3
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| EMC 88
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| C. Wheldon
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| Vol #:
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| 3
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| EMC 89
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| B. Drury
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| Vol #:
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| 3
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| EMC 90
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| D. Motley
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| Vol #:
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| 3
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| EMC 91
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| D. Kopel
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| Vol #:
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| 3
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| EMC
92
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| Hepatitis Education Project
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| Vol #:
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| 3
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| EMC 93
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| S. Turner
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| Vol #:
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| 3
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| EMC 94
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| S. Griffin
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| Vol #:
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| 3
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| EMC 95
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| F. Leenknecht
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| Vol #:
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| 3
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| EMC 96
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| F. Leenknecht
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| Vol #:
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| 3
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| EMC 97
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| O. Shachar, MD
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| Vol #:
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| 3
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|
|
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| 2003P-0362
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| Over-the-counter Hearing Aids
|
|
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|
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| EMC
38
|
| Audiology Foundation of America
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| Vol #:
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| 2
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| EMC
39
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| Hearing Centers Network
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| Vol #:
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| 2
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|
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| EMC
40
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| International Hearing Society (IHS)
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| Vol #:
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| 2
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|
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| 2003P-0363
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| Professional and Patient Labeling for Hearing Aid Devices
|
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| EMC
15
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| Audiology Foundation of America (AFA)
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| Vol #:
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| 1
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| EMC
16
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| Hearing Centers Network
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| Vol #:
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| 1
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|
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| EMC
17
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| International Hearing Society (IHS)
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| Vol #:
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| 1
|
|
|
|
|
| 2003P-0387
|
| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
|
|
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| EMC
6
|
| American Thyroid Assn
|
| Vol #:
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| 1
|
|
| | | | | | | | |
|
|
|
|
| 2003P-0438
|
| change the regulatory status of prenatal listening devices commonly called 'Doppler Fetoscopes' under 21 CFR 5.10
|
|
|
|
|
| EMC 1
|
| R. Thomsen, MD
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0479
|
| Allow importation of Canadian versions of drugs that are approved to the United States
|
|
|
|
|
| EMC 38
|
| D. Nelson
|
| Vol #:
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| 1
|
|
|
|
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| 2004D-0027
|
| Guidance for Industry on Time and Extent Applications
|
|
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
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| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
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| 1
|
|
|
|
|
| 2004D-0042
|
| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
|
|
|
|
|
| BKG
1
|
| Background Material
|
| Vol #:
|
| 1
|
|
|
|
|
| BKG
2
|
| Background Material
|
| Vol #:
|
| 1
|
|
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| GDL
2
|
| guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| GDL
3
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0006
|
| Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release
|
|
|
|
|
| SUP
2
|
| Purdue Pharma L P
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0061
|
| Take actions to establish guidance and clarify requirements for abbreviated new drug applications with regard to levothyroxine sodium products
|
|
|
|
|
| ACK 1
|
| HFA-305 to Reed Smith, LLP
|
| Vol #:
|
| 1
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|
|
|
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| CP
1
|
| Jerome Stevens Pharmaceuticals, Inc.
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| Vol #:
|
| 1
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|
