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Dockets Management

Dockets Entered On December 4, 2007
Docket # Title
1995N-0362 CGMP Certain Requirements for Finished Pharmaceuticals
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
2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
2006N-0168 Food Labeling: Reference Daily Intakes & Daily Reference Values
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2007F-0454 General Mills, Inc.; Filing of Food Additive Petition
2007N-0280 Amendment to the CGMP Regulations for Finished Pharmaceuticals
2007N-0343 Electronic Nonclinical Study Data Submission; Notice of Pilot Project
2007N-0348 Establishing a Docket for the Development of Safety and Effectiveness Assessments of Vaccines Used for Pandemic Influenza
2007N-0356 BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
2007N-0453 DSM Nutritional Products, Inc.; Filing of Color Additive Petition
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-0224 Take special consideration when reviewing amy application for a generic version of AMBIEN CR (zolpidem tartrate extended-release tablets)
2007P-0251 Petition for a policy statement requiring that all future advisory committee meetings discussing specific products include an oral scientific presentation by FDA staff on the products reviewed, includ
2007P-0438 Declare Angel Parfum, Angel Eau du Toilette and other Angel related fragranced products be declared misbranded and have their importation ceased until their safety can be independently verified
2007P-0470 Administrative action regarding CLOMID (clomiphene citrate), NDA 16-131 and its generics
1995N-0362 CGMP Certain Requirements for Finished Pharmaceuticals
NWL 1 FDA Vol #: 5
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 14 Wageningen University Vol #: 1
EC 15 Ms. Elizabeth Dufraine Vol #: 1
EC 16 Mr. Robert Perou Vol #: 1
EC 17 Mrs. Karen Lucas Vol #: 1
EC 18 Mrs. yolanda steward Vol #: 1
EC 19 Mr. Douglas Kolozsvari Vol #: 1
EC 20 Mr. Matthew Conlon Vol #: 1
EC 21 Mr. Stephen Hart Vol #: 1
EC 22 Radboud University Nijmeren Medical Centre Vol #: 1
EC 23 Menzies Research Institute Vol #: 1
EC 24 Georgian Society of Hypertension Vol #: 1
EC 25 Federico II Univ of Naples, Dept.Clin. Exp. Med. Vol #: 1
2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
C 25 National Venture Capital Associaton Vol #: 3
2006N-0168 Food Labeling: Reference Daily Intakes & Daily Reference Values
EC 105 Mr. Michael Jones Vol #: 1
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 491 M. Athinson Vol #: 14
2007F-0454 General Mills, Inc.; Filing of Food Additive Petition
NFL 1 FDA Vol #: 1
2007N-0280 Amendment to the CGMP Regulations for Finished Pharmaceuticals
NFR 1 FDA Vol #: 1
NPR 1 FDA Vol #: 1
2007N-0343 Electronic Nonclinical Study Data Submission; Notice of Pilot Project
EC 2 Merck Research Laboratories Vol #: 1
2007N-0348 Establishing a Docket for the Development of Safety and Effectiveness Assessments of Vaccines Used for Pandemic Influenza
EC 1 GlaxoSmithKline Vol #: 1
EC 2 Sanofi Pasteur Vol #: 1
EC 3 MedImmune, Inc. Vol #: 1
2007N-0356 BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
EC 112 Asthma and Allergy Foundation of America Vol #: 2
EC 113 Mr. Neil Abrahams Vol #: 2
EC 114 National Community Pharmacists Association Vol #: 2
EC 115 Dr. Geeta Khare Vol #: 2
EC 116 Center for Consumer Self Care,UCSF Sch.of Pharmacy Vol #: 2
EC 117 American Association of Clinical Endocrinologists Vol #: 2
EC 118 National Alliance of State Pharmacy Associations Vol #: 2
2007N-0453 DSM Nutritional Products, Inc.; Filing of Color Additive Petition
NFL 1 FDA 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 359 L. Gibbons Vol #: 102
2007P-0224 Take special consideration when reviewing amy application for a generic version of AMBIEN CR (zolpidem tartrate extended-release tablets)
LET 1 Jane A. Axelrad Vol #: 2
2007P-0251 Petition for a policy statement requiring that all future advisory committee meetings discussing specific products include an oral scientific presentation by FDA staff on the products reviewed, includ
EC 3 none Vol #: 1
2007P-0438 Declare Angel Parfum, Angel Eau du Toilette and other Angel related fragranced products be declared misbranded and have their importation ceased until their safety can be independently verified
EC 13 Mr. Dennis Stevens Vol #: 3
EC 14 Sam-1 Trust Vol #: 3
EC 15 Ms. Dani Cleve-Norton Vol #: 3
2007P-0470 Administrative action regarding CLOMID (clomiphene citrate), NDA 16-131 and its generics
ACK 1 FDA/DDM to Terence J. Mix, Esq. Vol #: 1
CP 1 Terence J. Mix, Esq. Vol #: 1

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