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Dockets Management

Dockets Entered On January 8, 2008
Docket # Title
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2004P-0448 DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)
2005N-0272 Irradiation in the Production, Processing & Handling of Food
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
2006F-0409 Safe Use of Cetylpyridinium Chloride as an Antimicrobial Agent in a Pre-chiller or Post-chiller Solution for Application to Raw Poultry Carcasses (FAP 6A4767)
2006N-0168 Food Labeling: Reference Daily Intakes & Daily Reference Values
2006N-0238 Debarment of Maria Anne Kirkman Campbell
2006P-0124 Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2007D-0419 Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Draft Guidance
2007D-0449 Guidance for Food and Drug Administration Advisory Committee Members and Food and Drug Administration Staff: Voting Procedures for Advisory Committee Meetings
2007D-0492 Guidance for Industry and Food and Drug Administration; Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
2007N-0432 Foodborne Listeria monocytogenes in Soft-Ripened Cheese, Risk Assessment of the Public Health Impact; Request for Comments and for Scientific Data and Information
2007N-0464 Health Claims and Qualified Health Claims; Dietary Lipids and Cancer, Soy Protein and Coronary Heart Disease, Antioxidant Vitamins and Certain Cancers, and Selenium and Certain Cancers; Reevaluation;
2007N-0471 Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
2007P-0085 Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
2007P-0297 Request to reconsider the failure to approve Provenge
2007P-0320 Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
2007P-0429 Take action to strengthen FDA regulation of controlled prescription drugs, and help minimize the risks of diversion of controlled prescription drugs, by issuing new rules
2007P-0500 Revoke the GRAS standing of the food additive Monosodium Glutamate
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 21296 Isaac Marcum Vol #: 183
LET 21297 Isaac Marcum Vol #: 183
LET 21298 Isaac Marcum Vol #: 183
LET 21299 Isaac Marcum Vol #: 183
LET 21300 Isaac Marcum Vol #: 183
LET 21301 Isaac Marcum Vol #: 183
LET 21302 Isaac Marcum Vol #: 183
LET 21303 Isaac Marcum Vol #: 183
LET 21304 Isaac Marcum Vol #: 183
LET 21305 Isaac Marcum Vol #: 183
LET 21306 Isaac Marcum Vol #: 183
2004P-0448 DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)
LET 8 Hill Dermaceuticals, Inc. Vol #: 1
2005N-0272 Irradiation in the Production, Processing & Handling of Food
C 3753 J. Sowinski et al Vol #: 61
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
EC 2125 B Sachau Vol #: 35
2006F-0409 Safe Use of Cetylpyridinium Chloride as an Antimicrobial Agent in a Pre-chiller or Post-chiller Solution for Application to Raw Poultry Carcasses (FAP 6A4767)
EC 13 Mrs. J Michael Vol #: 1
2006N-0168 Food Labeling: Reference Daily Intakes & Daily Reference Values
C 10 Shire Pharmaceuticals Vol #: 1
2006N-0238 Debarment of Maria Anne Kirkman Campbell
LET 7 FDA/CDER to Maria Anne Kirkman Campbell, M.D. Vol #: 1
2006P-0124 Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
SUP 4 ViroPharma Inc. Vol #: 2
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 526 Animal Humane Society Vol #: 14
2007D-0419 Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Draft Guidance
C 2 Novartis Pharmaceuticals Corporation Vol #: 1
EC 5 Merck Vol #: 1
2007D-0449 Guidance for Food and Drug Administration Advisory Committee Members and Food and Drug Administration Staff: Voting Procedures for Advisory Committee Meetings
EC 2 American Veterinary Medical Association Vol #: 1
2007D-0492 Guidance for Industry and Food and Drug Administration; Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
EC 1 Number not used Vol #: 1
2007N-0432 Foodborne Listeria monocytogenes in Soft-Ripened Cheese, Risk Assessment of the Public Health Impact; Request for Comments and for Scientific Data and Information
EC 2 European Commission Vol #: 1
2007N-0464 Health Claims and Qualified Health Claims; Dietary Lipids and Cancer, Soy Protein and Coronary Heart Disease, Antioxidant Vitamins and Certain Cancers, and Selenium and Certain Cancers; Reevaluation;
EC 2 Sunopta Grain and Food Vol #: 1
EC 3 Devansoy, Inc. Vol #: 1
EC 4 Pacific Soybean Vol #: 1
EC 5 SoyLink Vol #: 1
EC 6 SoyLink Vol #: 1
EC 7 Physicians Pharmaceuticals, Inc. Vol #: 1
2007N-0471 Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
EC 7 Mrs. Kathy Allen Vol #: 1
EC 8 Ms. Kavitha Balakrishnan Vol #: 1
EC 9 Mr. Leo Hallan Vol #: 1
EC 10 Mr. Angelo Limnios Vol #: 1
EC 11 Mr. Michael Lykins Vol #: 1
EC 12 spinal cord injured Vol #: 1
EC 13 Mr. Stephan Blanchard Vol #: 1
EC 14 www.stepnow.org Vol #: 1
EC 15 Mrs. Mariane Hinds Vol #: 1
EC 16 Mrs. Donna Sullivan Vol #: 1
EC 17 Mr. Paolo Cipolla Vol #: 1
EC 18 Mrs. Ann Waldersen Vol #: 1
EC 19 Mr. mark evans Vol #: 1
EC 20 Mrs. Patricia DeMatteo Vol #: 1
EC 21 Miss. arcangela stefanetti Vol #: 1
EC 22 Mr. Rick James Vol #: 1
EC 23 Mr. Ben Weatherman Vol #: 1
EC 24 Mr. Kim Donadei Vol #: 1
EC 25 Mr. Sean Normandeau Vol #: 1
EC 26 Mr. Lonnie Bissonnette Vol #: 1
2007P-0085 Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
C 367 Number Not Used Vol #: 102
2007P-0297 Request to reconsider the failure to approve Provenge
EC 150 Mr. Lawrence Shultz Vol #: 1
EC 151 Mr. Paul Gornall Vol #: 1
2007P-0320 Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
EC 22 Physicians for Social Responsibility Vol #: 1
2007P-0429 Take action to strengthen FDA regulation of controlled prescription drugs, and help minimize the risks of diversion of controlled prescription drugs, by issuing new rules
EC 1 COPES FOUNDATION Vol #: 1
2007P-0500 Revoke the GRAS standing of the food additive Monosodium Glutamate
EC 1 B. Sachau Vol #: 1

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