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| Dockets Entered
On June 4, 2004
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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| |
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| 1998N-0583
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| Exports: Notification and Recordkeeping requirements
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| |
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| |
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| 2003D-0309
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| Guidance for Industry and FDA staff: Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions [ 510(k)s] for Reprocessed Single-Use Medical Devices:
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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-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| 2003N-0567
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| Cardiovascular and Neurological Devices; Reclassification of Two Embolization Devices
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| |
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| |
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| 2003P-0531
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| Issue a report providing the necessary information on pill weight tolerances and/or variations caused by reformulations
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| |
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| 2003P-0555
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| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
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| |
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| 2004D-0001
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| Global Harmonization Task Force, Study Group 1, 2, 3 and 4; New Proposed and Final Documents; Availability
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| |
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| |
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| 2004D-0035
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| Guidance for Industry on the Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis
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| |
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| 2004D-0042
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| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
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| |
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| 2004D-0117
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| International Conference on Harmonisation; Draft Guidance on E2E Pharmacovigilance Planning
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| |
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| 2004D-0118
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| International Conference on Harmonisation; Draft Guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
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| |
|
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| 2004D-0156
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| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Guidance for Industry on b
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| |
|
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| 2004D-0192
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| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Using Screening Human Donors of Blood and Blood Components Draft Guidance
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| |
|
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| 2004M-0203
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| BP030025 / 0 Trinity Biotech Uni-Gold Recombigen HIV, Uni-Gold Recombigen HIV Positive and Negative Controls
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| |
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| 2004N-0049
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| |
|
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| 2004N-0115
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| Prescription Drug Importation Study
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| |
|
|
| 2004N-0133
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| Part 11, Electronic Record; Electronic Signatures; Public Meeting
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| |
|
|
| 2004N-0184
|
| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
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| |
|
|
| 2004N-0194
|
| DEFINITION OF PRIMARY MODE OF ACTION OF A COMBINATION PRODUCT
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| |
|
|
| 2004N-0217
|
| Nutrient content claims: DHA, EPA, and ALA (Omega-3 Fatty Acids)
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| |
|
|
| 2004P-0008
|
| Protection from Chlorinated Dibenzo-p-dioxins and Chlorodibenzofurans
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| |
|
|
| 2004P-0036
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| Office of Mental Health be deemed pharmacies of other health care entities language of 503(d)(3)(A)(ii), and be allwed to inventory and dispense drug samples to its patients
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| |
|
|
| 2004P-0075
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| Prohibit the marketing and distribution of Authorized Generics until the expiraration of the first generic applicant's exclusivity period.
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| |
|
|
| 2004P-0085
|
| Esmolol Hydrochloride for injection ,2,500 mg/vital in a lyophilized form is suitable for evaluation under an ANDA
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| |
|
|
| 2004P-0105
|
| Nutrient Content Claim: Total Carbohydrate Content of Foods
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| |
|
|
| 2004P-0107
|
| Nutrient Content Claim: Carbohydrate Content of Foods
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| |
|
|
| 2004P-0110
|
| Nutrient Content Claim: Carbohydrate Content of Foods
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| |
|
|
| 2004P-0113
|
| immediately remove from the market rosuvastatin (Crestor-AstraZeneca) before additional cases of life-threatening rhabdomyolysis and kidney/failure damage occur
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| |
|
|
| 2004P-0127
|
| ANADA suitability for ANTIROBE (clindamycin hydrochloride) capsules for dogs and cats (NADA 120-161)
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| |
|
|
| 2004P-0130
|
| ANADA for AMOXI-TABS (amoxicillin) for dogs and cats
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| |
|
|
| 2004P-0136
|
| ANADA Suitability Petition for Florfenicol Injectable Solution
|
|
| | | | | | | | |
| |
|
|
| 2004P-0202
|
| Notify State & Federal regulators of GRAS requirements of milk protein Concentrade
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| |
|
|
| 2004P-0220
|
| determine that the reference listed drug Zithromax (azithromycin) oral capsules,NDAS 50-670 was not withdrawn from sale for reasons related to safety or effectiveness
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| |
|
|
| 2004P-0223
|
| Whole Grain Descriptive Claims
|
| |
|
|
| 2004V-0191
|
| Laser Light Show
|
| |
|
|
| 2004V-0255
|
| Laser Display Device
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| LET
14090
|
| Integrative Therapeutics Inc.
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| Vol #:
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| 121
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| |
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| LET
14091
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| Integrative Therapeutics Inc.
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| Vol #:
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| 121
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| |
|
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| LET
14092
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| Enzymatic Therapy
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| Vol #:
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| 121
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| |
|
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| LET
14093
|
| Bayer HealthCare LLC
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| Vol #:
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| 121
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| |
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|
| 1998N-0583
|
| Exports: Notification and Recordkeeping requirements
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| |
|
|
| BKG
1
Tab 1, 2,
3
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| Background Material
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| Vol #:
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| 4
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| |
|
|
| NAP
1
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| FDA
|
| Vol #:
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| 4
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| |
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
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| |
|
|
| EXB 70
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| Center for Veterinary Medicine
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| Vol #:
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| 409
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| |
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| EXB 71
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| Center for Veterinary Medicine
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| Vol #:
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| 409
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| |
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| EXB 72
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| Center for Veterinary Medicine
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| Vol #:
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| 409
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| |
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| EXB 73
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| Center for Veterinary Medicine
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| Vol #:
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| 409
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| |
|
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| EXB 74
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| Center for Veterinary Medicine
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| Vol #:
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| 409
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| |
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| EXB 75
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| Center for Veterinary Medicine
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| Vol #:
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| 409
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| |
|
|
| EXB 76
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| Center for Veterinary Medicine
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| Vol #:
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| 409
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| |
|
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| EXB 77
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| Center for Veterinary Medicine
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| Vol #:
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| 409
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| |
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| EXB 78
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| Center for Veterinary Medicine
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| Vol #:
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| 409
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| |
|
|
| 2003D-0309
|
| Guidance for Industry and FDA staff: Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions [ 510(k)s] for Reprocessed Single-Use Medical Devices:
|
|
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|
|
|
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|
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| GDL
1
|
| Guidance
|
| Vol #:
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| 1
|
| |
|
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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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| |
|
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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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| |
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|
| C 25
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| F. Kummerow, PhD
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| Vol #:
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| 7
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| |
|
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| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| |
|
|
| C 106
|
| J. M. Korsmo
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| Vol #:
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| 15
|
| |
|
|
| 2003N-0567
|
| Cardiovascular and Neurological Devices; Reclassification of Two Embolization Devices
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|
| | | | | | | | |
| |
|
|
| C
1
Attachment
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| Boston Scientific Neurovascular
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| Vol #:
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| 1
|
| |
|
|
| 2003P-0270
|
| Prohibit False and Misleading Labeling
|
| |
|
|
| C
73
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| Compassion Over Killing
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| Vol #:
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| 6
|
| |
|
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| C 74
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| Dr. and Mrs M. Sinclair
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| Vol #:
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| 6
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| |
|
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| C 75
|
| Form Letters
|
| Vol #:
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| 8
|
| |
|
|
| 2003P-0531
|
| Issue a report providing the necessary information on pill weight tolerances and/or variations caused by reformulations
|
| |
|
|
| LET
1
|
| HFD-005 to Fulcrum, Inc.
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| Vol #:
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| 1
|
| |
|
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| 2003P-0555
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| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
|
| |
|
|
| C 14
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| S. Douglas
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| Vol #:
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| 2
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| |
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| C 15
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| J. Rose
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| Vol #:
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| 2
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| |
|
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| C 16
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| L. Knutsen
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| Vol #:
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| 2
|
| |
|
|
| 2004D-0001
|
| Global Harmonization Task Force, Study Group 1, 2, 3 and 4; New Proposed and Final Documents; Availability
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| |
|
|
| C
1
|
| Cook Group, Inc. (Cook)
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| Vol #:
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| 2
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| |
|
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| C
2
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| Abbott Laboratories
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| Vol #:
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| 2
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| |
|
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| C
3
|
| Advanced Medical Technology Assn (AdvaMed)
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| Vol #:
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| 2
|
| |
|
|
| 2004D-0002
|
| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
|
| |
|
|
| C
15
|
| Command Trust Network, Inc.
|
| Vol #:
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| 2
|
| |
|
|
| C
16
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| Inamed Corporation (Inamed)
|
| Vol #:
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| 2
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| |
|
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| C
17
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| The Sheridan Group
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| Vol #:
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| 2
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| |
|
|
| C 18
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| L. Feng, M.D.
|
| Vol #:
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| 2
|
| |
|
|
| 2004D-0035
|
| Guidance for Industry on the Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis
|
| |
|
|
| C
6
|
| Pharmaceutical Research and Manfacturers of America (PhRMA)
|
| Vol #:
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| 1
|
| |
|
|
| 2004D-0042
|
| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
|
| |
|
|
| C
28
|
| America's Health Insurance Plans (AHIP)
|
| Vol #:
|
| 2
|
| |
|
|
| C
29
|
| TAP Pharmaceutical Products, Inc (TAP)
|
| Vol #:
|
| 2
|
| |
|
|
| NEC
1
|
| FDA
|
| Vol #:
|
| 3
|
| |
|
|
| 2004D-0117
|
| International Conference on Harmonisation; Draft Guidance on E2E Pharmacovigilance Planning
|
| |
|
|
| C
2
|
| Plasma Protein Therapeutics Assn (PPTA)
|
| Vol #:
|
| 1
|
| |
|
|
| C
3
|
| Novartis Pharmaceuticals, Corp.
|
| Vol #:
|
| 1
|
| |
|
|
| C
4
|
| Schering-Plough
|
| Vol #:
|
| 1
|
| |
|
|
| C
5
|
| GlaxoSmithKline (GSK)
|
| Vol #:
|
| 1
|
| |
|
|
| C
6
|
| HIV Vaccine Trials Network
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| C
7
|
| Abbott Laboratories (Abbott)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004D-0118
|
| International Conference on Harmonisation; Draft Guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
|
| |
|
|
| C
1
|
| Aventis Pharmaceuticals, Inc. (Aventis)
|
| Vol #:
|
| 1
|
| |
|
|
| C
2
|
| Genentech, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004D-0156
|
| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Guidance for Industry on b
|
| |
|
|
| C
2
|
| Keep Antibiotics Working (KAW)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004D-0192
|
| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Using Screening Human Donors of Blood and Blood Components Draft Guidance
|
|
|
|
|
|
|
| |
|
|
| C
1
|
| Mayo Clinic
|
| Vol #:
|
| 1
|
| |
|
|
| 2004M-0203
|
| BP030025 / 0 Trinity Biotech Uni-Gold Recombigen HIV, Uni-Gold Recombigen HIV Positive and Negative Controls
|
| |
|
|
| AAV
1
|
| HFM-310 to Trinity Biotech plc
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0049
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
|
|
|
|
|
|
| |
|
|
| C 4
|
| J.M. Korsmo
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0115
|
| Prescription Drug Importation Study
|
| |
|
|
| C
28
|
| National Association of Boards of Pharmacy (NABP)
|
| Vol #:
|
| 19
|
| |
|
|
| C
29
|
| Flex Products, Inc
|
| Vol #:
|
| 19
|
| |
|
|
| 2004N-0133
|
| Part 11, Electronic Record; Electronic Signatures; Public Meeting
|
| |
|
|
| C
6
|
| Hoffman-La Roche, Ltd
|
| Vol #:
|
| 2
|
| |
|
|
| C
7
|
| Aventis Pharmaceuticals, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| C
8
|
| GlaxoSmithKline (GSK)
|
| Vol #:
|
| 2
|
| |
|
|
| 2004N-0184
|
| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
|
| |
|
|
| C
1
|
| Quality Systems Consultants, Inc. (QSC)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0194
|
| DEFINITION OF PRIMARY MODE OF ACTION OF A COMBINATION PRODUCT
|
| |
|
|
| EXT
1
|
| Advanced Medical Technology Assn (AdvaMed)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0217
|
| Nutrient content claims: DHA, EPA, and ALA (Omega-3 Fatty Acids)
|
| |
|
|
| C
1
|
| Insitute of Medicine (IOM)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0008
|
| Protection from Chlorinated Dibenzo-p-dioxins and Chlorodibenzofurans
|
| |
|
|
| C
2
|
| Kinsale Environment Watch
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0036
|
| Office of Mental Health be deemed pharmacies of other health care entities language of 503(d)(3)(A)(ii), and be allwed to inventory and dispense drug samples to its patients
|
|
| | | | | | | | |
| |
|
|
| PAV
1
|
| HFC-1 to State of Louisiana Department of Health and Hospitals
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0075
|
| Prohibit the marketing and distribution of Authorized Generics until the expiraration of the first generic applicant's exclusivity period.
|
| |
|
|
| C
2
|
| Johnson & Johnson
|
| Vol #:
|
| 1
|
| |
|
|
| C
3
|
| Generic Pharmaceutical Assn (GPhA)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0085
|
| Esmolol Hydrochloride for injection ,2,500 mg/vital in a lyophilized form is suitable for evaluation under an ANDA
|
| |
|
|
| C
1
|
| Baxter Healthcare Corporation (Baxter)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0105
|
| Nutrient Content Claim: Total Carbohydrate Content of Foods
|
| |
|
|
| C
2
|
| Nestle USA, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| C
3
|
| Low Carb Creations
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0107
|
| Nutrient Content Claim: Carbohydrate Content of Foods
|
| |
|
|
| C
2
|
| Nestle USA, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| C
3
|
| Low Carb Creations
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0110
|
| Nutrient Content Claim: Carbohydrate Content of Foods
|
| |
|
|
| C
2
|
| Nestle USA, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| C
3
|
| Low Carb Creations
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0113
|
| immediately remove from the market rosuvastatin (Crestor-AstraZeneca) before additional cases of life-threatening rhabdomyolysis and kidney/failure damage occur
|
| |
|
|
| C
1
|
| Public Citizen
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0127
|
| ANADA suitability for ANTIROBE (clindamycin hydrochloride) capsules for dogs and cats (NADA 120-161)
|
| |
|
|
| PDN
1
|
| HFV-100 to Smart Drug Systems, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0130
|
| ANADA for AMOXI-TABS (amoxicillin) for dogs and cats
|
| |
|
|
| WDL
1
|
| Smart Drug Systems, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0136
|
| ANADA Suitability Petition for Florfenicol Injectable Solution
|
| |
|
|
| PAV
1
|
| HFV-100 to Intervet, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0202
|
| Notify State & Federal regulators of GRAS requirements of milk protein Concentrade
|
| |
|
|
| C 1
|
| J. Kinsman
|
| Vol #:
|
| 1
|
| |
|
|
| C 2
|
| J. Fitzgerald
|
| Vol #:
|
| 1
|
| |
|
|
| C 3
|
| Form Letters
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0220
|
| determine that the reference listed drug Zithromax (azithromycin) oral capsules,NDAS 50-670 was not withdrawn from sale for reasons related to safety or effectiveness
|
| |
|
|
| CR
1
|
| Wapner,Newman,Wigrizer,Brecher
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0223
|
| Whole Grain Descriptive Claims
|
|
| | | | | | | | |
| |
|
|
| CR
1
|
| General Mills, Inc.
|
| Vol #:
|
| 5
|
| |
|
|
| 2004V-0191
|
| Laser Light Show
|
| |
|
|
| VRA
1
|
| HFZ-300 to New Jersey State Museum Planetarium
|
| Vol #:
|
| 1
|
| |
|
|
| 2004V-0255
|
| Laser Display Device
|
| |
|
|
| ACK
1
|
| HFA-305 to Texas State Technical College
|
| Vol #:
|
| 1
|
| |
|
|
| VAR
1
|
| Texas State Technical College
|
| Vol #:
|
| 1
|
|
|
