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| Dockets Entered
On March 19, 2007
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| Docket #
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| Title
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| 1976N-0052G
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| OTC general comments & combinations
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| 1995G-0321
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| 25-hydroxyvitamin D3 be affirmed as GRAS
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1999P-4613
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| Revoke the Regulation That Approved Posilac
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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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| 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-0324
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| New Animal Drugs; Removal of Obsolete and Redundant Regulations
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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-0573
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| Draft Animal Cloning Risk Assessment
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| 2004N-0257
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| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
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| 2004P-0349
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| Action on Products containing added Mercury
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| 2004P-0464
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| Vitamin D & Calcium & Reduced Risk of Osteoporosis
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| 2005N-0373
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| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| 2005P-0237
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| Re-Listing Petition to determine that two strenghths, 50 mg and 250 mg lamotrigene oral tablets, were not withdrawn due to safety nor efficacy concerns
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| 2006D-0480
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| Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
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| 2006D-0526
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| International Conference on Harmonisation; Draft Guidance on E15 Terminology in Pharmacogenomics
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| 2006N-0061
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| Charging for Investigational Drugs
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| 2006N-0062
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| Expanded Access to Investigational Drugs for Treatment Use
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| 2006N-0130
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Trans Fatty Acids in Nutrition Labeling
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| 2006N-0472
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
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| 2006N-0525
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| Supplements and Other Changes to an Approved Application
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| 2006P-0124
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| Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
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| 2006P-0173
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| Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product
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|
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| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
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|
|
|
| 2006P-0423
|
| Regulate Labeling and Packaging of Acetaminophen/APAP Containing Products
|
|
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|
|
| 2006P-0535
|
| Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
|
|
|
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|
| 2007D-0040
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| Guidance for Industry on Developing Products for Weight Management
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|
|
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|
| 2007D-0080
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| Guidance for Industry on Indexing Structured Product Labeling
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| 2007N-0073
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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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| 2007P-0100
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| Abbreviated New Drug Application (ANDA) filing of Ciprofloxacin Hydrochloride Capsules, 100mg, 250mg, and 750mg
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| | | | | | | | |
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| |
|
| 1976N-0052G
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| OTC general comments & combinations
|
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|
|
|
| NFR 5
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| FDA
|
| Vol #:
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| 35
|
|
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|
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| 1995G-0321
|
| 25-hydroxyvitamin D3 be affirmed as GRAS
|
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|
|
| EMC 1
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| B. Sachau
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| Vol #:
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| 1
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|
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| EMC 2
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| B. Achau
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| Vol #:
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| 1
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| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
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| EMC 4441
|
| A. Travis
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| Vol #:
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| 320
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|
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| 1999P-4613
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| Revoke the Regulation That Approved Posilac
|
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| EMC 2434
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| A. Devik
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| Vol #:
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| 46
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|
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| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
|
|
| EMC 1339
|
| G. Cadrett
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| Vol #:
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| 6
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|
|
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| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
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|
|
| EMC 776
|
| Mission Possible International
|
| Vol #:
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| 10
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|
|
|
|
| EMC 777
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| Mission Possible International
|
| Vol #:
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| 10
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|
|
|
|
| EMC 778
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| Mission Possible International
|
| Vol #:
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| 10
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|
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|
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| EMC 779
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| Mission Possible International
|
| Vol #:
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| 10
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|
|
|
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 1455
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| C. Rowland
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| Vol #:
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| 12
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| EMC 1456
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| G. Thomas
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| Vol #:
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| 12
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|
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| EMC 1457
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| A. Flynn
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| Vol #:
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| 12
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| EMC 1458
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| B. Chavis
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| Vol #:
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| 12
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| EMC 1459
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| M. Brewer
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| Vol #:
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| 12
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|
|
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| EMC 1460
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| J. Goliboski
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| Vol #:
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| 12
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|
|
|
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| EMC 1461
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| No Submitter
|
| Vol #:
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| 12
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|
|
|
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| EMC 1462
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| K. James
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| Vol #:
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| 12
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|
|
|
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| 2003N-0324
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| New Animal Drugs; Removal of Obsolete and Redundant Regulations
|
|
|
|
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| APE 1
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| PennField Oil Company/PennField Animal Health
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| Vol #:
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| 1
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|
|
|
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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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|
|
|
|
| EREG 3
|
| C. Van Schalkwyk
|
| Vol #:
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| 15
|
|
|
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
|
|
|
|
| EC 3509
|
| Ms. Sonia Ramirez
|
| Vol #:
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| 21
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|
| | | | | | | | |
|
| |
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| EC 1821
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| Mr. John Bowen
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| Vol #:
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| 31
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|
|
|
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| EC 1822
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| Mrs. Jennifer Marrandette
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| Vol #:
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| 31
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|
|
|
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| EREG 48
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| Celiac Sprue Association
|
| Vol #:
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| 32
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|
|
|
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| EREG 49
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| CSA Celiacs
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| Vol #:
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| 32
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|
|
|
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| 2005N-0354
|
| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
|
|
|
|
| EMC 592
|
| The National Medical Association
|
| Vol #:
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| 12
|
|
|
|
|
| 2005N-0373
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| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
|
|
|
|
|
| EMC 2
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| S. Rainbolt-Kren
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| Vol #:
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| 8
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|
|
|
|
| EMC 3
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| R. Ihnen
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| Vol #:
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| 8
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|
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|
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| EMC 4
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| Biotechnology Industry Organization
|
| Vol #:
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| 8
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|
|
|
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| EREG 5
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| FedEx Express
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| Vol #:
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| 8
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|
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| EREG 6
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| Pharmaceutical Research and Manufactuers of America
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| Vol #:
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| 8
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|
| |
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
|
|
|
|
|
|
|
|
|
|
|
| C 98
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| National Welders Supply Company
|
| Vol #:
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| 10
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|
|
|
|
| EMC 6
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| C. Robinson
|
| Vol #:
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| 6
|
|
|
|
|
| EMC 7
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| Consumer Healthcare Products Association
|
| Vol #:
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| 6
|
|
|
|
|
| EMC 8
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| National Marrow Donor Program
|
| Vol #:
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| 6
|
|
|
|
|
| EMC 9
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| Animal Health Insititute
|
| Vol #:
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| 6
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|
|
|
|
| EMC 10
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| CVS Pharmacy
|
| Vol #:
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| 6
|
|
|
|
|
| EMC 11
|
| Johnson & Johnson Pharmaceutical Group
|
| Vol #:
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| 6
|
|
|
|
|
| EMC 12
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| Wolters Kluwer Health
|
| Vol #:
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| 6
|
|
|
|
|
| 2005P-0237
|
| Re-Listing Petition to determine that two strenghths, 50 mg and 250 mg lamotrigene oral tablets, were not withdrawn due to safety nor efficacy concerns
|
|
|
|
|
| LET 2
|
| FDA/CDER to Pharmaceutical Patent Attorneys
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
|
|
| C 14
|
| XDx Inc
|
| Vol #:
|
| 1
|
|
| |
|
| 2006D-0480
|
| Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
|
|
|
|
|
| C 1
|
| Mayo Clinic
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0526
|
| International Conference on Harmonisation; Draft Guidance on E15 Terminology in Pharmacogenomics
|
|
|
|
|
| EMC 1
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0061
|
| Charging for Investigational Drugs
|
|
|
|
|
| C 8
|
| Baxter Healthcare Corporation
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| C 9
|
| America's Health Insurance Plans (AHIP)
|
| Vol #:
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| 1
|
|
|
|
|
| C 10
|
| Toucan Capital Corp
|
| Vol #:
|
| 1
|
|
|
|
|
| C 11
|
| TAP Pharmaceutical Products Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| C 12
|
| R Reinhard
|
| Vol #:
|
| 1
|
|
|
|
|
| C 13
|
| Plasma Protein Therapeutics Association (PPTA)
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 12
|
| Abigail Alliance
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 13
|
| California Dept. of Health Services
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 14
|
| California Dept. of Health Services
|
| Vol #:
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| 1
|
|
|
|
|
| EC 15
|
| Pharm Res
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 16
|
| FIU International Business Student
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 17
|
| Johnson and Johnson
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 18
|
| FIU Busines Student
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 19
|
| GlaxoSmithKline
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 20
|
| N/A
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 21
|
| Sepracor Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 22
|
| Blue Cross and Blue Shield Association
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 23
|
| National Patient Advocate Foundation
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 24
|
| Cancer Leadership Council
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 25
|
| Cystic Fibrosis Foundation
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 26
|
| American Society of Clinical Oncology (ASCO)
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 27
|
| PPTA
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 28
|
| Mr. James Ingram
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 29
|
| Toucan Capital
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 2
|
| R. Reinhard
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0062
|
| Expanded Access to Investigational Drugs for Treatment Use
|
|
|
|
|
| C 14
|
| R Chamblin
|
| Vol #:
|
| 1
|
|
|
|
|
| C 15
|
| Baxter Healthcare Corporation
|
| Vol #:
|
| 1
|
|
|
|
|
| C 16
|
| Hemophilia Federation of America
|
| Vol #:
|
| 1
|
|
|
|
|
| C 17
|
| America's Health Insurance Plans (AHIP)
|
| Vol #:
|
| 1
|
|
|
|
|
| C 18
|
| B Wilson
|
| Vol #:
|
| 1
|
|
|
|
|
| C 19
|
| R Wilson
|
| Vol #:
|
| 1
|
|
|
|
|
| C 20
|
| TAP Pharmaceutical Products Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| C 21
|
| Toucan Capital Corp.
|
| Vol #:
|
| 1
|
|
|
|
|
| C 22
|
| Plasma Protein Therapeutics Association (PPTA)
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 60
|
| Mr. Roger Luca
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 61
|
| Mrs. Lynn Youngblom
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| EREG 2
|
| S. Slotterbeck
|
| Vol #:
|
| 1
|
|
|
|
|
| EREG 3
|
| Greater New York Hospital Association
|
| Vol #:
|
| 1
|
|
| |
|
| 2006N-0130
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Trans Fatty Acids in Nutrition Labeling
|
|
|
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0352
|
| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
|
|
|
|
|
| LET 11
|
| FDA to Hon James P Moran, House of Representatives
|
| Vol #:
|
| 36
|
|
|
|
|
| 2006N-0472
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
|
|
|
|
|
|
|
|
|
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
| |
|
| 2006N-0525
|
| Supplements and Other Changes to an Approved Application
|
|
|
|
|
| EMC 2
|
| Consumer Healthcare Products Association
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0124
|
| Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
|
|
|
|
|
| EMC 2
|
| ViroPharma Incorporated
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0173
|
| Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product
|
|
|
|
|
|
|
|
|
|
|
| SUP 3
|
| Wyeth Pharmaceuticals
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
|
|
| C 70
|
| K Hoyt
|
| Vol #:
|
| 7
|
|
|
|
|
| C 71
|
| R Fuentes
|
| Vol #:
|
| 7
|
|
|
|
|
| C 72
|
| A Lopez
|
| Vol #:
|
| 7
|
|
|
|
|
| C 73
|
| S Schwartz
|
| Vol #:
|
| 7
|
|
|
|
|
| 2006P-0423
|
| Regulate Labeling and Packaging of Acetaminophen/APAP Containing Products
|
|
|
|
|
| SUP 1
|
| Pharmacists Plannning Services, Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0535
|
| Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
|
|
|
|
|
| LET 2
|
| Coalition for Mercury Free Drugs
|
| Vol #:
|
| 1
|
|
| |
|
| 2007D-0040
|
| Guidance for Industry on Developing Products for Weight Management
|
|
|
|
|
| C 1
|
| University of Alabama At Birmingham, Duke University Medical Centre
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007D-0080
|
| Guidance for Industry on Indexing Structured Product Labeling
|
|
|
|
|
| GDL 1
|
| Draft Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
|
