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Dockets Management

Dockets Entered On November 9, 2007
Docket # Title
1978N-0038 Sunscreen Drug Products
1996N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements
2000D-0084 Guidance for Industry: Special Protocol Assessment
2000D-1598 Voluntary Labeling for Bioengineered Foods
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
2007D-0233 Guidance for Industry on Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document
2007D-0419 Draft Guidance for Industry on Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment
2007E-0445 Patent Extension Application for Neupro, U.S. Patent No. 6,884,434
2007M-0366 BP060001/0, CryoSeal FS System
2007N-0277 Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
2007N-0343 Electronic Nonclinical Study Data Submission; Notice of Pilot Project
2007N-0356 BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
2007N-0422 Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program
2007N-0430 Agency Emergency Processing Under OMB Review; Common EMEA/FDA Application Form for Orphan Medicinal Product Designation (form FDA 3671)
2007P-0037 Declare that Loratadine Orally-Dissolving Strips, 5mg and 10mg, for an abbreviated new drug application (ANDA)
2007P-0333 Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa
2007P-0400 Formally ban unnaturally synthesized fluoride compounds sold for consumption through oral ingestion
1978N-0038 Sunscreen Drug Products
C 626 The Aaqembly State of New York Albany Vol #: 163
C 627 Lynn Economic Opporyunity, Inc. Vol #: 163
C 628 Holliknoll Farm Vol #: 163
C 629 Skin Cancer Foundation Vol #: 163
C 630 American Academy of Dermatology Vol #: 163
C 631 Ellington Gift Baskets Vol #: 163
C 632 DSM Nutritional Products, Ltd. Vol #: 163
C 633 Aquea Scientific Vol #: 163
C 634 Dermatology surgery Vol #: 163
C 635 Morgan Lewis Counselors At Law Vol #: 163
C 636 Commonwealth of Virginia House of Delegates Richmond Vol #: 163
C 637 Commonwealth of Virginia House of Delegates Richmond Vol #: 163
EXT 18 Cosmetic, Toiletry, and Frogrance Association Vol #: 163
1996N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements
C 287 Number not used Vol #: 54
C 288 Number not used Vol #: 54
2000D-0084 Guidance for Industry: Special Protocol Assessment
C 9 Novo Nordisk Vol #: 1
2000D-1598 Voluntary Labeling for Bioengineered Foods
C 10025 A. Bergner Vol #: 580
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
C 4250 B. J. Montgomery Vol #: 40
C 4251 S. Sechler Vol #: 40
C 4252 S. L. Gray Vol #: 40
C 4253 N. Vazquez Vol #: 40
2007D-0233 Guidance for Industry on Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document
C 1 Novo Nordisk Vol #: 1
2007D-0419 Draft Guidance for Industry on Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2007E-0445 Patent Extension Application for Neupro, U.S. Patent No. 6,884,434
APP 1 The United States Patent Trade Office Vol #: 1
LET 1 Schwarz Pharma Limited Vol #: 1
2007M-0366 BP060001/0, CryoSeal FS System
NAD 1 FDA Vol #: 1
2007N-0277 Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
C 2 Private Label Manufacturers Association (PLMA) Vol #: 1
2007N-0343 Electronic Nonclinical Study Data Submission; Notice of Pilot Project
LET 2 Sanofi aventis Vol #: 1
2007N-0356 BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
C 4 American Osteopathic Association Vol #: 1
2007N-0422 Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program
N 1 FDA Vol #: 1
2007N-0430 Agency Emergency Processing Under OMB Review; Common EMEA/FDA Application Form for Orphan Medicinal Product Designation (form FDA 3671)
N 1 FDA Vol #: 1
2007P-0037 Declare that Loratadine Orally-Dissolving Strips, 5mg and 10mg, for an abbreviated new drug application (ANDA)
WDL 1 Lachman Consultant Services, Inc. Vol #: 1
2007P-0333 Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa
ACK 11 FDA/DDM to Shawn Bryant Vol #: 1
ACK 12 FDA/DDM to James Whaler Vol #: 1
CP 11 Shawn Bryant Vol #: 1
CP 12 James Whaler Vol #: 1
2007P-0400 Formally ban unnaturally synthesized fluoride compounds sold for consumption through oral ingestion
C 1 R. D. Sauerheber Vol #: 1

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