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| Dockets Entered
On September 14, 2004
Table of Contents
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| Docket #
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| Title
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| 1996N-0417
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| CGMP in Mfg. Packing
or Holding Dietary Supplements
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| 1997S-0163
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| Dietary Supplements,
Courtesy Letters (Letters of Objection)
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| 1999P-5106
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| Identify Sources of
Natural Flavorings
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| 2000D-1598
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| Voluntary Labeling
for Bioengineered Foods
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| 2000N-1396
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| Bioengineered Foods
Consumed By Humans or Animals
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| 2000N-1571
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| Enrofloxacin for Poultry:
Opportunity for Hearing
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| 2001P-0075
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| Switch Status of Emergency
Contraceptives from Rx to OTC
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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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| 2004D-0193
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| Guidance for Industry: Eligibility
Determination for Donors of Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps)
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|
|
| 2004D-0377
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| International Conference
on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc
Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic
Drugs
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|
|
|
|
| 2004D-0378
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| International
Conference on Harmonisation; Draft Guidance on S7B Nonclinical Evaluation
of the Potential for Delayed Ventricular Repolarization (QT Interval
Prolongation) by Human Pharmaceuticals
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|
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| 2004N-0184
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| Requirements Pertaining to Sampling
and Private Laboratories Used in Connection With Importing Food
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| 2004N-0264
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| Federal Measures to
Mitigate BSE Risks: Considerations for Further Action
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|
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| 2004P-0409
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| metoclopramide hydrochloride
orally disintegrating tablets 5 mg & 10 mg suitable for ANDA
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| 2004P-0417
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| ANDA Doryx (coated
doxycycline hyclate pellets) in powder or other fill present
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| 2004P-0418
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| Atorvastatin Calcium
Capsules, 10mg, 20mg, 40mg, and 80mg for an abbreviated new drug application
(ANDA)
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| 2004P-0419
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| de nova classification of NeoGram
Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model
MS-8970
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| 2004S-0233
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| Stimulating Innovation
in Medical Technologies
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|
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| 1996N-0417
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| CGMP in Mfg. Packing
or Holding Dietary Supplements
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| EMC 264
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| H. Buchanan
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| Vol #:
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| 43
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| 1997S-0163
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| Dietary Supplements,
Courtesy Letters (Letters of Objection)
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| LET
772
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| HFS-800 to Jarrow
Formulas
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| Vol #:
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| 23
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| LET
773
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| HFS-800 to Heather
& Company for IBS, LLC
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| Vol #:
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| 23
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| LET
774
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| HFS-800 to BioZak,
Inc
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| Vol #:
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| 23
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| LET
775
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| HFS-800 to Highland
Laboratories
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| Vol #:
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| 23
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| LET
776
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| HFS-800 to Dietary
Supplement Systems Global, Inc
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| Vol #:
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| 23
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| LET
777
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| HFS-800 to Vital Nutrients
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| Vol #:
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| 23
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| LET
778
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| HFS-800 to Daily Wellness
Company
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| Vol #:
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| 23
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| 1999P-5106
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| Identify Sources
of Natural Flavorings
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| EMC 205
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| A. Bartholomew
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| Vol #:
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| 3
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| 2000D-1598
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| Voluntary Labeling
for Bioengineered Foods
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| EMC 12019
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| T. Dover
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| Vol #:
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| 574
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| 2000N-1396
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| Bioengineered Foods
Consumed By Humans or Animals
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| EMC 11573
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| T. Dover
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| Vol #:
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| 349
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| 2000N-1571
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| Enrofloxacin for
Poultry: Opportunity for Hearing
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|
| | | | | | | | |
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| |
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| EMC 10296
|
| E. McGovern
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| Vol #:
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| 287
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| EMC 10297
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| B. Fanney
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| Vol #:
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| 287
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| EMC 10298
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| G. Sandifer
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| Vol #:
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| 287
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| EMC 10299
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| J. Sidfrid
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| Vol #:
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| 287
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| EMC 10300
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| E. Edenfield
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| Vol #:
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| 287
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| EMC 10301
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| S. Young
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| Vol #:
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| 287
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| EMC 10302
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| E. Seitz
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| Vol #:
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| 287
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| EMC 10303
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| S. Hisry
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| Vol #:
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| 287
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| EMC 10304
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| K. Colburn
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| Vol #:
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| 287
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| EMC 10305
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| K. Plant
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| Vol #:
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| 287
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| EMC 10306
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| S. Moore
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| Vol #:
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| 287
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| EMC 10307
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| S. Fischer
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| Vol #:
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| 287
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| EMC 10308
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| C. Evans
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| Vol #:
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| 287
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|
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| EMC 10309
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| S. Burton
|
| Vol #:
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| 287
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|
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| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
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| EMC 1245
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| N. Abromson
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| Vol #:
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| 5
|
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| 2004D-0193
|
| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
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|
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| EC
2
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| HIV Medicine Association
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| Vol #:
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| 1
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| EC
3
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| The Sperm Bank of California
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| Vol #:
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| 1
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| EC
4
Attachment
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| Assoc for Professionals in Infection Control
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| Vol #:
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| 1
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| EC 5
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| Mr. Jonathan Givner
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| Vol #:
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| 1
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| EC
6
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| America's Blood Centers
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| Vol #:
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| 1
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| EC
7
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| AABB
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| Vol #:
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| 1
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| 2004D-0377
|
| International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
|
|
|
|
|
|
|
|
|
| GDL
1
|
| Guidance
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| Vol #:
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| 1
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|
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|
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| NAD
1
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| FDA
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| Vol #:
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| 1
|
|
|
|
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| 2004D-0378
|
| International Conference on Harmonisation; Draft Guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
|
|
|
|
|
|
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
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| 1
|
|
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|
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| NAD
1
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| FDA
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| Vol #:
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| 1
|
|
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| 2004N-0184
|
| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
|
|
|
|
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| EC
2
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| National Coalition of Food Importing Associations
|
| Vol #:
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| 2
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
|
| | | | | | | | |
|
| |
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| C
132
|
| Penn State University
|
| Vol #:
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| 22
|
|
|
|
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| 2004P-0409
|
| metoclopramide hydrochloride orally disintegrating tablets 5 mg & 10 mg suitable for ANDA
|
|
|
|
|
| ACK
1
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| HFA-305 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
|
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| |
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| 2004P-0417
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| ANDA Doryx (coated doxycycline hyclate pellets) in powder or other fill present
|
|
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| ACK
1
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| HFA-305 to F H Faulding & Co. Limited t/a Mayne Pharma Int'l
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| Vol #:
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| 1
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| CP
1
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| F H Faulding & Co. Limited t/a Mayne Pharma Int'l
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| Vol #:
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| 1
|
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| 2004P-0418
|
| Atorvastatin Calcium Capsules, 10mg, 20mg, 40mg, and 80mg for an abbreviated new drug application (ANDA)
|
|
|
|
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| ACK
1
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| HFA-305 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| CP
1
Attachment 1,
2, 3
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| Lachman Consultant Services, Inc.
|
| Vol #:
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| 1
|
|
|
|
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| 2004P-0419
|
| de nova classification of NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model MS-8970
|
|
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| CP
1
|
| PerkinElmer Life and Analytical Sciences
|
| Vol #:
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| 1
|
|
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| PAV
1
|
| HFZ-440 to PerkinElmer Life and Analytical Sciences
|
| Vol #:
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| 1
|
|
|
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| 2004S-0233
|
| Stimulating Innovation in Medical Technologies
|
|
|
|
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| EC
6
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| Cardionetics Ltd
|
| Vol #:
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| 2
|
|
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| EC
7
Attachment
|
| Blue Cross and Blue Shield Association
|
| Vol #:
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| 2
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| EC
8
Attachment
|
| Association of Community Cancer Centers
|
| Vol #:
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| 2
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| EC
9
Attachment
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| Advanced Medical Technology Association
|
| Vol #:
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| 2
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| EC
10
Attachment
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| FasterCures
|
| Vol #:
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| 2
|
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| EC
11
|
| Medical Product Innovation
|
| Vol #:
|
| 2
|
|
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| EC
12
Attachment
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| BIO
|
| Vol #:
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| 2
|
|
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| EC
13
|
| Value Group
|
| Vol #:
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| 2
|
|
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| EC
14
|
| Boston Scientific Corporation
|
| Vol #:
|
| 2
|
|
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| EC
15
Attachment
|
| SAS Institute
|
| Vol #:
|
| 2
|
|
