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| Dockets Entered
On December 26, 2007
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| Docket #
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| Title
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| 1978N-0038
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| Sunscreen Drug Products
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| 1998D-0307
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| Exports/Imports under FDA export reform/enhancement Act 1996
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| 2002D-0049
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| Disclosure of Conflicts of Interest for Special Gov, Employe
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| 2005P-0450
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| 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
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| 2007C-0474
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| DSM Nutritional Products, Inc.; Filing of Color Additive Petition
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| 2007D-0364
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| Impact-Resistant Lenses: Questions and Answers Guidance
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| 2007D-0365
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| Guidance for Industry on The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 Current Good Manufacturing Practice (CGMP)
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| 2007D-0367
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| Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval
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| 2007D-0386
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| Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
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| 2007D-0388
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| 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
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| 2007D-0396
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| Drug-Induced Liver Injury: Premarketing Clinical Evaluation;Draft Guidance
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| 2007D-0419
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| Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Draft Guidance
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| 2007D-0449
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| Guidance for Food and Drug Administration Advisory Committee Members and Food and Drug Administration Staff: Voting Procedures for Advisory Committee Meetings
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| 2007N-0353
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| Drug Products Containing Hydrocodone; Enforcement Action Dates
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| 2007N-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| 2007N-0412
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| Adolescent Over-the-Counter Drug Product Use
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| 2007N-0417
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| Acarbose Tablets and 180-day exclusivity
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| 2007N-0472
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| Agency Emergency Processing Under OMB Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
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| 2007N-0480
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| Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Products Marketed Life Cycle; Public Workshop
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| 2007P-0047
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| Amend the Dosage of Oral Phenylephrine Listed in the Final Monogrph on Oral Decongestants
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| 2007P-0400
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| Formally ban unnaturally synthesized fluoride compounds sold for consumption through oral ingestion
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| 1978N-0038
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| Sunscreen Drug Products
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| C 714
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| Shiseido America Technocenter
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| Vol #:
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| 176
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| C 715
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| Unilever
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| Vol #:
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| 176
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| C 716
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| Energizer Personal Care
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| Vol #:
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| 176
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| C 717
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| CHPA, Personal Care Products Council
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| Vol #:
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| 179
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| EC 2717
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| Natural Resources Defense Council
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| Vol #:
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| 176
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| EC 2718
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| DSM Nutritional Products Ltd
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| Vol #:
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| 176
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| EC 2719
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| Northwestern University
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| Vol #:
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| 176
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| EC 2720
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| BASF
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| Vol #:
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| 176
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| EC 2721
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| Beauty Cosmedics, Inc.
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| Vol #:
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| 176
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| EC 2722
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| The Procter
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| Vol #:
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| 176
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| EC 2723
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| Kobo Products Inc.
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| Vol #:
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| 176
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| EC 2724
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| Croda Inc.
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| Vol #:
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| 176
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| EC 2725
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| Croda Inc.
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| Vol #:
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| 176
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| EREG 18
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| Johnson & Jonson Consumer & Personel Products Worldwide
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| Vol #:
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| 176
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| 1998D-0307
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| Exports/Imports under FDA export reform/enhancement Act 1996
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| EC 65
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| Ms. Diane Dinsmore
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| Vol #:
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| 2
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| 2002D-0049
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| Disclosure of Conflicts of Interest for Special Gov, Employe
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| EC 2
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| American Society of Clinical Oncology
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| Vol #:
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| 1
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| C 106
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| V. & M. Toso
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| Vol #:
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| 9
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| 2005P-0450
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| 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
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| EC 39
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| Ms. karla mcbride
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| Vol #:
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| 1
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| EC 40
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| Not Applicable
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| Vol #:
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| 1
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| EC 41
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| Dr. Caryl Nowson
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| Vol #:
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| 1
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| 2007C-0474
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| DSM Nutritional Products, Inc.; Filing of Color Additive Petition
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| NCR 1
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| FDA
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| Vol #:
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| 1
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| 2007D-0364
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| Impact-Resistant Lenses: Questions and Answers Guidance
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| EXT 1
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| Vision Council of America (VCA)
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| Vol #:
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| 1
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| 2007D-0365
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| Guidance for Industry on The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 Current Good Manufacturing Practice (CGMP)
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| EC 3
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| Hanson Research Corp.
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| Vol #:
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| 1
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| 2007D-0367
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| Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval
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| EC 1
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| Sanofi-aventis
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| Vol #:
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| 1
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| 2007D-0386
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| Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
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| EC 1
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| Boehringer Ingelheim Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| EC 2
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| CHPA
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| Vol #:
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| 1
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| EC 3
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| Drug Safety Alliance
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| Vol #:
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| 1
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| EC 4
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| The Wood Burditt Group
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| Vol #:
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| 1
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| EC 5
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| Alcon
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| Vol #:
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| 1
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| 2007D-0388
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| 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
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| EC 6
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| Hyman, Phelps
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| Vol #:
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| 1
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| EC 7
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| Natural Solutions Foundation
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| Vol #:
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| 1
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| 2007D-0396
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| Drug-Induced Liver Injury: Premarketing Clinical Evaluation;Draft Guidance
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| C 5
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| Swedich MPA
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| Vol #:
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| 1
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| EC 2
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| Merck
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| Vol #:
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| 1
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| EC 3
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| GlaxoSmithKline
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| Vol #:
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| 1
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| EC 4
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| Boehringer Ingelheim Pharmaceuticals, Inc
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| Vol #:
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| 1
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| EC 5
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| Sanofi-aventis U.S. Inc
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| Vol #:
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| 1
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| EC 6
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| Pharm Res
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| Vol #:
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| 1
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| 2007D-0419
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| Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Draft Guidance
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| EC 1
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| Leiden University Medical Center
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| Vol #:
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| 1
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| 2007D-0449
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| Guidance for Food and Drug Administration Advisory Committee Members and Food and Drug Administration Staff: Voting Procedures for Advisory Committee Meetings
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| EC 1
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| American Society of Clinical Oncology
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| Vol #:
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| 1
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| 2007N-0353
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| Drug Products Containing Hydrocodone; Enforcement Action Dates
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| ACK 1
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| FDA/DDM to GRAS/E Coalition
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| Vol #:
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| 1
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| PRC 1
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| GRAS/E Coalition
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| Vol #:
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| 1
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| 2007N-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| EC 130
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| American Society of Consultant Pharmacists
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| Vol #:
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| 5
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| EC 131
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| Medco Health Solutions, Inc.
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| Vol #:
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| 5
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| EC 132
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| American Society of Health-System Pharmacists
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| Vol #:
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| 5
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| EC 133
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| AANMA
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| Vol #:
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| 5
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| EC 134
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| American Geriatrics Society
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| Vol #:
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| 5
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| EC 135
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| Miss. Laurie Tansman
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| Vol #:
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| 5
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| EC 136
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| Reproductive Health Technologies Project
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| Vol #:
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| 5
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| EC 137
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| Food Marketing Institute
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| Vol #:
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| 5
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| EC 138
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| North Carolina Medical Society
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| Vol #:
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| 5
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| EC 139
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| Organization of Teratology Information Specialists
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| Vol #:
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| 5
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| EC 140
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| Pharmacy Access Partnership
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| Vol #:
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| 5
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| EC 141
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| Rite Aid Corporation
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| Vol #:
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| 5
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| EC 142
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| Mr. Lawrence Joseph
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| Vol #:
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| 5
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| EC 143
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| Academy of Managed Care Pharmacy
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| Vol #:
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| 5
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| EC 144
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| Express Scripts, Inc.
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| Vol #:
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| 5
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| EC 145
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| Pharmaceutical Care Management Association
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| Vol #:
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| 5
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| EC 146
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| Consumer Healthcare Products Association
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| Vol #:
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| 5
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| EC 147
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| Ibis Reproductive Health
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| Vol #:
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| 5
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| EC 148
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| NACDS
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| Vol #:
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| 5
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| EC 149
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| American Pharmacists Association
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| Vol #:
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| 5
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| EC 150
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| American Pharmacists Association
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| Vol #:
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| 5
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| EC 151
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| Emron, LLC
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| Vol #:
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| 5
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| 2007N-0412
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| Adolescent Over-the-Counter Drug Product Use
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| LST 1
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| FDA
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| Vol #:
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| 1
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| 2007N-0417
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| Acarbose Tablets and 180-day exclusivity
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| LST 1
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| Number erronously used
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| Vol #:
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| 1
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| LST 2
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| Number erronously used
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| Vol #:
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| 1
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| LST 3
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| Number erronously used
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| Vol #:
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| 1
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| 2007N-0472
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| Agency Emergency Processing Under OMB Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
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| NCR 1
|
| FDA
|
| Vol #:
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| 1
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|
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| 2007N-0480
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| Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Products Marketed Life Cycle; Public Workshop
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| NM 1
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| FDA
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| Vol #:
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| 1
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| 2007P-0047
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| Amend the Dosage of Oral Phenylephrine Listed in the Final Monogrph on Oral Decongestants
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| C 1
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| American Academy of Pediatrics
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| Vol #:
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| 1
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| 2007P-0400
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| Formally ban unnaturally synthesized fluoride compounds sold for consumption through oral ingestion
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| EC 3
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| Mrs. stephanie joseph
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| Vol #:
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| 1
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