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Dockets Management

Dockets Entered On December 26, 2007
Docket # Title
1978N-0038 Sunscreen Drug Products
1998D-0307 Exports/Imports under FDA export reform/enhancement Act 1996
2002D-0049 Disclosure of Conflicts of Interest for Special Gov, Employe
2004Q-0151 Qualified Health Claim (QHC): soy protein and cancer
2005P-0450 Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
2007C-0474 DSM Nutritional Products, Inc.; Filing of Color Additive Petition
2007D-0364 Impact-Resistant Lenses: Questions and Answers Guidance
2007D-0365 Guidance for Industry on The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 Current Good Manufacturing Practice (CGMP)
2007D-0367 Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval
2007D-0386 Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
2007D-0388 Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protec
2007D-0396 Drug-Induced Liver Injury: Premarketing Clinical Evaluation;Draft Guidance
2007D-0419 Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Draft Guidance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
2007N-0353 Drug Products Containing Hydrocodone; Enforcement Action Dates
2007N-0356 BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
2007N-0412 Adolescent Over-the-Counter Drug Product Use
2007N-0417 Acarbose Tablets and 180-day exclusivity
2007N-0472 Agency Emergency Processing Under OMB Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
2007N-0480 Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Products Marketed Life Cycle; Public Workshop
2007P-0047 Amend the Dosage of Oral Phenylephrine Listed in the Final Monogrph on Oral Decongestants
2007P-0400 Formally ban unnaturally synthesized fluoride compounds sold for consumption through oral ingestion
1978N-0038 Sunscreen Drug Products
C 714 Shiseido America Technocenter Vol #: 176
C 715 Unilever Vol #: 176
C 716 Energizer Personal Care Vol #: 176
C 717 CHPA, Personal Care Products Council Vol #: 179
EC 2717 Natural Resources Defense Council Vol #: 176
EC 2718 DSM Nutritional Products Ltd Vol #: 176
EC 2719 Northwestern University Vol #: 176
EC 2720 BASF Vol #: 176
EC 2721 Beauty Cosmedics, Inc. Vol #: 176
EC 2722 The Procter Vol #: 176
EC 2723 Kobo Products Inc. Vol #: 176
EC 2724 Croda Inc. Vol #: 176
EC 2725 Croda Inc. Vol #: 176
EREG 18 Johnson & Jonson Consumer & Personel Products Worldwide Vol #: 176
1998D-0307 Exports/Imports under FDA export reform/enhancement Act 1996
EC 65 Ms. Diane Dinsmore Vol #: 2
2002D-0049 Disclosure of Conflicts of Interest for Special Gov, Employe
EC 2 American Society of Clinical Oncology Vol #: 1
2004Q-0151 Qualified Health Claim (QHC): soy protein and cancer
C 106 V. & M. Toso Vol #: 9
2005P-0450 Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
EC 39 Ms. karla mcbride Vol #: 1
EC 40 Not Applicable Vol #: 1
EC 41 Dr. Caryl Nowson Vol #: 1
2007C-0474 DSM Nutritional Products, Inc.; Filing of Color Additive Petition
NCR 1 FDA Vol #: 1
2007D-0364 Impact-Resistant Lenses: Questions and Answers Guidance
EXT 1 Vision Council of America (VCA) Vol #: 1
2007D-0365 Guidance for Industry on The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 Current Good Manufacturing Practice (CGMP)
EC 3 Hanson Research Corp. Vol #: 1
2007D-0367 Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval
EC 1 Sanofi-aventis Vol #: 1
2007D-0386 Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
EC 1 Boehringer Ingelheim Pharmaceuticals, Inc. Vol #: 1
EC 2 CHPA Vol #: 1
EC 3 Drug Safety Alliance Vol #: 1
EC 4 The Wood Burditt Group Vol #: 1
EC 5 Alcon Vol #: 1
2007D-0388 Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protec
EC 6 Hyman, Phelps Vol #: 1
EC 7 Natural Solutions Foundation Vol #: 1
2007D-0396 Drug-Induced Liver Injury: Premarketing Clinical Evaluation;Draft Guidance
C 5 Swedich MPA Vol #: 1
EC 2 Merck Vol #: 1
EC 3 GlaxoSmithKline Vol #: 1
EC 4 Boehringer Ingelheim Pharmaceuticals, Inc Vol #: 1
EC 5 Sanofi-aventis U.S. Inc Vol #: 1
EC 6 Pharm Res Vol #: 1
2007D-0419 Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Draft Guidance
EC 1 Leiden University Medical Center 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 1 American Society of Clinical Oncology Vol #: 1
2007N-0353 Drug Products Containing Hydrocodone; Enforcement Action Dates
ACK 1 FDA/DDM to GRAS/E Coalition Vol #: 1
PRC 1 GRAS/E Coalition Vol #: 1
2007N-0356 BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
EC 130 American Society of Consultant Pharmacists Vol #: 5
EC 131 Medco Health Solutions, Inc. Vol #: 5
EC 132 American Society of Health-System Pharmacists Vol #: 5
EC 133 AANMA Vol #: 5
EC 134 American Geriatrics Society Vol #: 5
EC 135 Miss. Laurie Tansman Vol #: 5
EC 136 Reproductive Health Technologies Project Vol #: 5
EC 137 Food Marketing Institute Vol #: 5
EC 138 North Carolina Medical Society Vol #: 5
EC 139 Organization of Teratology Information Specialists Vol #: 5
EC 140 Pharmacy Access Partnership Vol #: 5
EC 141 Rite Aid Corporation Vol #: 5
EC 142 Mr. Lawrence Joseph Vol #: 5
EC 143 Academy of Managed Care Pharmacy Vol #: 5
EC 144 Express Scripts, Inc. Vol #: 5
EC 145 Pharmaceutical Care Management Association Vol #: 5
EC 146 Consumer Healthcare Products Association Vol #: 5
EC 147 Ibis Reproductive Health Vol #: 5
EC 148 NACDS Vol #: 5
EC 149 American Pharmacists Association Vol #: 5
EC 150 American Pharmacists Association Vol #: 5
EC 151 Emron, LLC Vol #: 5
2007N-0412 Adolescent Over-the-Counter Drug Product Use
LST 1 FDA Vol #: 1
2007N-0417 Acarbose Tablets and 180-day exclusivity
LST 1 Number erronously used Vol #: 1
LST 2 Number erronously used Vol #: 1
LST 3 Number erronously used Vol #: 1
2007N-0472 Agency Emergency Processing Under OMB Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
NCR 1 FDA Vol #: 1
2007N-0480 Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Products Marketed Life Cycle; Public Workshop
NM 1 FDA Vol #: 1
2007P-0047 Amend the Dosage of Oral Phenylephrine Listed in the Final Monogrph on Oral Decongestants
C 1 American Academy of Pediatrics Vol #: 1
2007P-0400 Formally ban unnaturally synthesized fluoride compounds sold for consumption through oral ingestion
EC 3 Mrs. stephanie joseph Vol #: 1

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