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| Dockets Entered
On March 28, 2006
Table of Contents
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| Docket #
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| Title
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| 1976N-0052N
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| OTC Nasal Decongestants
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| 1981N-0022
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| OTC Weight Control Drug Products for Human Use
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| 1989V-0516
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| Laser Light Show Re: Omnichrome Laser
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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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| |
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| 2001D-0489
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| Establishment & Operation of Clinical Trial Monitoring Comm
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| |
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| 2004N-0230
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| Food; Current Good Manufacturing Practice Regulations; Public Meetings
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| |
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| |
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| 2005D-0481
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| Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Do
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| 2005N-0285
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| Current Good Manufacturing Practice Regulation and Investigational New Drugs
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| |
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| 2005N-0329
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| Designation of New Animal Drugs for Minor Uses or Minor Species
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| |
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| 2005N-0395
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| Agency Information Collection: Guidance on Formal Meetings with Sponsors and Applicants for PDUFA
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| 2005N-0484
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, and Distributor Reporting
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| 2005N-0507
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| Agency Emergency Processing Under OMB Review; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable
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| 2005P-0182
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| Withdraw April 14, 2003, Warning Letter, CBER 03-010, addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA
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| 2005P-0325
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| Request Commissioner of Food and Drugs to amend its regulations related to sugar and alternative sweeteners
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| 2005P-0402
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| Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic-depressive illness."
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2005P-0436
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| ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.
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| 1976N-0052N
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| OTC Nasal Decongestants
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| C 248
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| Bayer Healthcare, LLC
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| Vol #:
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| 92
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| 1981N-0022
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| OTC Weight Control Drug Products for Human Use
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| C 123
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| Block Drug Company (Block)
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| Vol #:
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| 93
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| C 124
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| GlaxoSmithKline Consumer Healthcare, LP (GSK)
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| Vol #:
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| 93
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| C 125
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| Wyeth Consumer Healthcare
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| Vol #:
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| 93
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| C 126
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| Bayer Healthcare, LLC
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| Vol #:
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| 104
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| 1989V-0516
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| Laser Light Show Re: Omnichrome Laser
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| VRA 9
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| HFZ-200 to Mr. Faith's Sound and Light Inc.
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| Vol #:
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| 1
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|
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 17396
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| Market America, Inc.
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| Vol #:
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| 160
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| | | | | | | | |
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| LET 17397
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| Enzymatic Therapy
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| Vol #:
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| 160
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| |
|
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| LET 17398
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| Enzymatic Therapy
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| Vol #:
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| 160
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| |
|
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| LET 17399
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| Enzymatic Therapy
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| Vol #:
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| 160
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| |
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| LET 17400
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| Nature's Way Products, Inc.
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| Vol #:
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| 160
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| |
|
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| LET 17401
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| Jarrow Formulas
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| Vol #:
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| 160
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| |
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| LET 17402
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| Jarrow Formulas
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| Vol #:
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| 160
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| |
|
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| LET 17403
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| Jarrow Formulas
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| Vol #:
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| 160
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| |
|
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| LET 17404
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| Jarrow Formulas
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| Vol #:
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| 160
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| |
|
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| LET 17405
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| Jarrow Formulas
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| Vol #:
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| 160
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| |
|
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| LET 17406
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| Jarrow Formulas
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| Vol #:
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| 160
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| |
|
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| LET 17407
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| Jarrow Formulas
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| Vol #:
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| 160
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| |
|
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| LET 17408
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| Jarrow Formulas
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| Vol #:
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| 160
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| |
|
|
| LET 17409
|
| Jarrow Formulas
|
| Vol #:
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| 160
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| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| C 7526
|
| D. Lytle
|
| Vol #:
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| 320
|
| |
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| |
|
|
| C 18257
|
| C. Baird
|
| Vol #:
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| 516
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| |
|
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| C 18258
|
| A. Gonzalez
|
| Vol #:
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| 516
|
| |
|
|
| 2000P-1211
|
| Establish Mandatory Pre-Market Safety Testing for GE Foods
|
| |
|
|
| C 12850
|
| C. Baird
|
| Vol #:
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| 806
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| |
|
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| C 12851
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| A. Gonzalez
|
| Vol #:
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| 806
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|
| |
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| 2001D-0489
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| Establishment & Operation of Clinical Trial Monitoring Comm
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| |
|
|
| BKG 1
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| Background Material
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| Vol #:
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| 2
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| |
|
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| NAD 2
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| FDA
|
| Vol #:
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| 2
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| |
|
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| 2004N-0230
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| Food; Current Good Manufacturing Practice Regulations; Public Meetings
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| |
|
|
| C 643
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| United Fresh Fruit & Vegetable Association (United)
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| Vol #:
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| 11
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| |
|
|
| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| |
|
|
| CR 1
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| Amended Transcript of 11/16/2004 Public Meeting
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| Vol #:
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| 4
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| |
|
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| TR 1
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| Transcript of 11/16/2004 Public Meeting
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| Vol #:
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| 3
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| |
|
|
| 2005D-0481
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| Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Do
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| C 9
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| Center for Environmental Health and Communities for a Better Environment
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| Vol #:
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| 1
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|
| | | | | | | | |
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| 2005N-0285
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| Current Good Manufacturing Practice Regulation and Investigational New Drugs
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| |
|
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| C 3
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| Plasma Protein Therapeutics Association (PPTA)
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| Vol #:
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| 1
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| |
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| 2005N-0329
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| Designation of New Animal Drugs for Minor Uses or Minor Species
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| |
|
|
| REF 1
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| OMB Review for September 27, 2005 (70 FR 56394)
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| Vol #:
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| 1
|
|
| |
|
| 2005N-0395
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| Agency Information Collection: Guidance on Formal Meetings with Sponsors and Applicants for PDUFA
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| |
|
|
| NAL 1
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| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2005N-0484
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, and Distributor Reporting
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|
|
| |
|
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| N 2
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| FDA
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| Vol #:
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| 1
|
|
| |
|
| 2005N-0507
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| Agency Emergency Processing Under OMB Review; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable
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|
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|
|
|
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| |
|
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| NAL 1
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| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2005P-0182
|
| Withdraw April 14, 2003, Warning Letter, CBER 03-010, addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA
|
| |
|
|
| LET 5
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| Simpson Woolley McConachie LLP
|
| Vol #:
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| 2
|
| |
|
|
| 2005P-0325
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| Request Commissioner of Food and Drugs to amend its regulations related to sugar and alternative sweeteners
|
| |
|
|
| C 1
|
| Chandler-Gilbert Community College
|
| Vol #:
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| 2
|
|
| |
|
| 2005P-0402
|
| Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic- depressive illness."
|
|
|
|
|
|
|
| |
|
|
| LET 1
|
| HFD-005 to Arnold & Porter LLP
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| Vol #:
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| 5
|
| |
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| |
|
|
| C 4263
|
| T. Stone
|
| Vol #:
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| 69
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| |
|
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| C 4264
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| L. Stone
|
| Vol #:
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| 69
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| |
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| C 4265
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| M. Shibicky
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| Vol #:
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| 69
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| |
|
|
| C 4266
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| J. Waterman
|
| Vol #:
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| 69
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| |
|
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| C 4267
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| V. Ogden
|
| Vol #:
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| 69
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| |
|
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| C 4268
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| J. Hartman
|
| Vol #:
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| 69
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| |
|
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| C 4269
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| B. Lakowski
|
| Vol #:
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| 69
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| |
|
|
| C 4270
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| M. Michels
|
| Vol #:
|
| 69
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| |
|
|
| C 4271
|
| J. Lindlow
|
| Vol #:
|
| 69
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| |
|
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| C 4272
|
| K. Lynch
|
| Vol #:
|
| 69
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| |
|
|
| C 4273
|
| K. Pellissier
|
| Vol #:
|
| 69
|
| |
|
|
| C 4274
|
| J. Waterman
|
| Vol #:
|
| 69
|
| |
|
|
| C 4275
|
| K. Rabe
|
| Vol #:
|
| 69
|
|
| | | | | | | |
|
| |
|
| C 4276
|
| C. Clarke
|
| Vol #:
|
| 69
|
| |
|
|
| C 4277
|
| D. Moore
|
| Vol #:
|
| 69
|
| |
|
|
| C 4278
|
| M. Simpson
|
| Vol #:
|
| 69
|
| |
|
|
| C 4279
|
| E. Womaek
|
| Vol #:
|
| 69
|
| |
|
|
| C 4280
|
| M. Buchanan
|
| Vol #:
|
| 69
|
| |
|
|
| C 4281
|
| D. Shufeldt
|
| Vol #:
|
| 69
|
| |
|
|
| C 4282
|
| F. Newberry
|
| Vol #:
|
| 69
|
| |
|
|
| C 4283
|
| S. Tanner
|
| Vol #:
|
| 69
|
| |
|
|
| C 4284
|
| J. Lake
|
| Vol #:
|
| 69
|
| |
|
|
| C 4285
|
| S. Lunder
|
| Vol #:
|
| 69
|
| |
|
|
| C 4286
|
| B. Berrick
|
| Vol #:
|
| 69
|
| |
|
|
| C 4287
|
| W. Ross
|
| Vol #:
|
| 69
|
| |
|
|
| C 4288
|
| R. Kimbol
|
| Vol #:
|
| 69
|
| |
|
|
| C 4289
|
| J. Johnson
|
| Vol #:
|
| 69
|
| |
|
|
| C 4290
|
| J. Hutchins
|
| Vol #:
|
| 69
|
| |
|
|
| C 4291
|
| A. Silverthorne
|
| Vol #:
|
| 69
|
| |
|
|
| C 4292
|
| L. Cato
|
| Vol #:
|
| 69
|
| |
|
|
| C 4293
|
| L. Karolefski
|
| Vol #:
|
| 69
|
| |
|
|
| C 4294
|
| C. Kellison
|
| Vol #:
|
| 69
|
| |
|
|
| C 4295
|
| A. Hart
|
| Vol #:
|
| 69
|
| |
|
|
| C 4296
|
| S. Sirien
|
| Vol #:
|
| 69
|
| |
|
|
| C 4297
|
| N. Rountree
|
| Vol #:
|
| 69
|
| |
|
|
| C 4298
|
| S. Stull
|
| Vol #:
|
| 69
|
| |
|
|
| C 4299
|
| K. Plait
|
| Vol #:
|
| 69
|
| |
|
|
| C 4300
|
| J. Carlson, MD
|
| Vol #:
|
| 69
|
| |
|
|
| C 4301
|
| C. Larson
|
| Vol #:
|
| 69
|
| |
|
|
| C 4302
|
| M. Moore
|
| Vol #:
|
| 69
|
| |
|
|
| C 4303
|
| L. Rynearson
|
| Vol #:
|
| 69
|
| |
|
|
| C 4304
|
| S. Childress
|
| Vol #:
|
| 69
|
| |
|
|
| C 4305
|
| B. Radtke
|
| Vol #:
|
| 69
|
| |
|
|
| C 4306
|
| J. Growney, M.D.
|
| Vol #:
|
| 69
|
| |
|
|
| C 4307
|
| S. Barbee
|
| Vol #:
|
| 69
|
| |
|
|
| C 4308
|
| M. Sand
|
| Vol #:
|
| 69
|
| |
|
|
| C 4309
|
| S. Pinsley, DO
|
| Vol #:
|
| 69
|
| |
|
|
| C 4310
|
| S. Branoff
|
| Vol #:
|
| 69
|
| |
|
|
| C 4311
|
| B. Voobhees
|
| Vol #:
|
| 69
|
| |
|
|
| C 4312
|
| M. Caskey
|
| Vol #:
|
| 69
|
|
| | | | | | | |
|
| |
|
| C 4313
|
| G. Nicholsen
|
| Vol #:
|
| 69
|
| |
|
|
| C 4314
|
| J. Stangel, MD
|
| Vol #:
|
| 69
|
| |
|
|
| C 4315
|
| J. Moore
|
| Vol #:
|
| 69
|
| |
|
|
| C 4316
|
| C. Smith
|
| Vol #:
|
| 69
|
| |
|
|
| C 4317
|
| E. Woodyard
|
| Vol #:
|
| 69
|
| |
|
|
| C 4318
|
| J. Snow, R.Ph.
|
| Vol #:
|
| 69
|
| |
|
|
| C 4319
|
| N. Fountain
|
| Vol #:
|
| 69
|
| |
|
|
| C 4320
|
| J. Carrier
|
| Vol #:
|
| 69
|
| |
|
|
| C 4321
|
| M. Harrington
|
| Vol #:
|
| 69
|
| |
|
|
| C 4322
|
| G. Bailey
|
| Vol #:
|
| 69
|
| |
|
|
| C 4323
|
| C. Schmidt
|
| Vol #:
|
| 69
|
| |
|
|
| C 4324
|
| N. Abrams
|
| Vol #:
|
| 69
|
| |
|
|
| C 4325
|
| M. Maxwell, MD
|
| Vol #:
|
| 69
|
| |
|
|
| C 4326
|
| D. Waddell
|
| Vol #:
|
| 69
|
| |
|
|
| C 4327
|
| E. MArquardt, M.D.
|
| Vol #:
|
| 69
|
| |
|
|
| C 4328
|
| M. Canteberry
|
| Vol #:
|
| 69
|
| |
|
|
| C 4329
|
| B. Morrison
|
| Vol #:
|
| 69
|
| |
|
|
| C 4330
|
| E. Sutchiffe
|
| Vol #:
|
| 69
|
| |
|
|
| C 4331
|
| V. Thackwell
|
| Vol #:
|
| 69
|
| |
|
|
| C 4332
|
| J. Taylor
|
| Vol #:
|
| 69
|
| |
|
|
| C 4333
|
| C. Modine
|
| Vol #:
|
| 69
|
| |
|
|
| C 4334
|
| B. Jones
|
| Vol #:
|
| 69
|
| |
|
|
| C 4335
|
| S. Imershein, MD
|
| Vol #:
|
| 69
|
| |
|
|
| C 4336
|
| S. Bush
|
| Vol #:
|
| 69
|
| |
|
|
| C 4337
|
| S. Bush
|
| Vol #:
|
| 69
|
| |
|
|
| C 4338
|
| J. Costello
|
| Vol #:
|
| 69
|
| |
|
|
| C 4339
|
| A. Beisser
|
| Vol #:
|
| 69
|
| |
|
|
| C 4340
|
| B. Marks
|
| Vol #:
|
| 69
|
| |
|
|
| C 4341
|
| K. Cook
|
| Vol #:
|
| 69
|
| |
|
|
| C 4342
|
| K. Browning
|
| Vol #:
|
| 69
|
| |
|
|
| C 4343
|
| T. Grigg
|
| Vol #:
|
| 69
|
| |
|
|
| C 4344
|
| D. Boggeri
|
| Vol #:
|
| 69
|
| |
|
|
| C 4345
|
| M. Lyles
|
| Vol #:
|
| 69
|
| |
|
|
| C 4346
|
| Y. Quinories
|
| Vol #:
|
| 69
|
| |
|
|
| C 4347
|
| Y. Quinories
|
| Vol #:
|
| 69
|
| |
|
|
| C 4348
|
| S. Brown
|
| Vol #:
|
| 69
|
| |
|
|
| C 4349
|
| S. Rich
|
| Vol #:
|
| 69
|
|
| | | | | | | | |
|
| |
|
| C 4350
|
| M. Lamarche
|
| Vol #:
|
| 69
|
| |
|
|
| C 4351
|
| B. Danney
|
| Vol #:
|
| 69
|
| |
|
|
| C 4352
|
| S. Kupersmith
|
| Vol #:
|
| 69
|
| |
|
|
| C 4353
|
| D. Eidenier
|
| Vol #:
|
| 69
|
| |
|
|
| C 4354
|
| M & J Bettenoonrt
|
| Vol #:
|
| 69
|
| |
|
|
| C 4355
|
| M & J Bettenoonrt
|
| Vol #:
|
| 69
|
| |
|
|
| C 4356
|
| R. Marshall
|
| Vol #:
|
| 69
|
| |
|
|
| C 4357
|
| D. MArshall
|
| Vol #:
|
| 69
|
| |
|
|
| C 4358
|
| S. Estes
|
| Vol #:
|
| 69
|
| |
|
|
| C 4359
|
| K. Wavering
|
| Vol #:
|
| 69
|
| |
|
|
| C 4360
|
| J. Scarborough
|
| Vol #:
|
| 69
|
| |
|
|
| C 4361
|
| A. Vining
|
| Vol #:
|
| 69
|
| |
|
|
| C 4362
|
| P. Tonkin
|
| Vol #:
|
| 69
|
| |
|
|
| C 4363
|
| C. Kellett
|
| Vol #:
|
| 69
|
| |
|
|
| C 4364
|
| T. Mitchell
|
| Vol #:
|
| 69
|
| |
|
|
| C 4365
|
| S. Farver
|
| Vol #:
|
| 69
|
| |
|
|
| C 4366
|
| L. Bakos
|
| Vol #:
|
| 69
|
| |
|
|
| C 4367
|
| D. Francois
|
| Vol #:
|
| 69
|
| |
|
|
| C 4368
|
| R. Belle, RN
|
| Vol #:
|
| 69
|
| |
|
|
| C 4369
|
| S. Tanner
|
| Vol #:
|
| 69
|
| |
|
|
| C 4370
|
| T. Eilling, MD
|
| Vol #:
|
| 69
|
| |
|
|
| C 4371
|
| C. Sachs
|
| Vol #:
|
| 69
|
| |
|
|
| C 4372
|
| D. Kelley
|
| Vol #:
|
| 69
|
| |
|
|
| C 4373
|
| B. Thurman
|
| Vol #:
|
| 69
|
| |
|
|
| C 4374
|
| K. Phillips
|
| Vol #:
|
| 69
|
| |
|
|
| 2005P-0436
|
| ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.
|
| |
|
|
| C 2
|
| Buc & Beardsley
|
| Vol #:
|
| 1
|
|
|
