| | | | | | | | | | |
|
|
| 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| Draft Guidance for Industry on Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment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)
|
|