| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On March 30, 2007
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1995S-0158
|
| Community Disclosure of Institutional Review Boards
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| 2000V-1576
|
| AN/PEQ-2A, Target Pointer-Illuminator/Aiming Light
|
|
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
|
|
| 2002P-0122
|
| Request Rulemaking on Functional Foods & Establish Adv. Com.
|
|
|
|
|
| 2002V-0230
|
| Laser Light Show, Laser Fantasy International-Rainbow I Proj
|
|
|
|
|
| 2002V-0347
|
| Laser light show
|
|
|
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
|
|
|
|
| 2003V-0293
|
| Laser Light Show
|
|
|
|
|
| 2004P-0448
|
| DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)
|
|
|
|
|
| 2005H-0271
|
| Civil Money Penalty: TMJ Implants, Inc.
|
|
|
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
|
|
|
|
| 2005N-0373
|
| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
|
|
| 2006N-0062
|
| Expanded Access to Investigational Drugs for Treatment Use
|
|
|
|
|
| 2006N-0525
|
| Supplements and Other Changes to an Approved Application
|
|
|
|
|
| 2006P-0094
|
| To undertake rulemaking to establish specific rules and regulations governing the definition of natural before a natural claim can be made on foods and beverages regulated by the FDA
|
|
|
|
|
| 2006P-0103
|
| ANDA Suitability for Temazepam Orally Disintegrating Tablets, 7.5 mg, 15 mg, 22.5 mg, and 30 mg
|
|
|
|
|
| 2006P-0173
|
| Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product
|
|
|
|
|
| 2006P-0209
|
| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
|
|
|
|
|
| 2006P-0403
|
| Determine whether an Abbreviated New Drug Application can be filed against the listed drug Novamine 15%, manufactured by Hospira under NDA 17-957
|
|
|
|
|
| 2006P-0415
|
| Petition Seeking Regulation of Cloned Animals
|
|
|
|
|
| 2006P-0498
|
| Use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods
|
|
|
|
|
| 2007D-0089
|
| Guidance for Industry and Review Staff on Target Product Profile A Strategic Development Process Tool
|
|
|
|
|
| 2007D-0101
|
| Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
|
|
|
|
|
| 2007N-0099
|
| New Drugs Exempted From Prescription-Dispensing Requirements; Technical Amendment
|
|
|
|
|
| 2007N-0105
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Mental Models Study of Food Bioterrorism Risk Awareness
|
|
|
|
|
| 2007P-0065
|
| To increase print size of direct-to-consumer advertisements
|
|
|
|
|
| 2007P-0124
|
| ANDA Suitability for clindamycin phosphate foam (non-aerosol), 1%
|
|
| |
|
| 1995S-0158
|
| Community Disclosure of Institutional Review Boards
|
|
|
|
|
| RPT 21
|
| Immediate Trial - Emerson Hospital Emergency Medical Services - IND 70,376
|
| Vol #:
|
| 55
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| LET 19781
|
| Bluebonnet Nutrition Corporation
|
| Vol #:
|
| 174
|
|
|
|
|
| LET 19782
|
| Bluebonnet Nutrition Corporation
|
| Vol #:
|
| 174
|
|
| | | | | | | | |
|
| |
|
| 2000V-1576
|
| AN/PEQ-2A, Target Pointer-Illuminator/Aiming Light
|
|
|
|
|
| VRA 8
|
| FDA/CDRH to Insight Technology Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
|
|
| C 370
|
| P Dolinsky
|
| Vol #:
|
| 30
|
|
| |
|
| 2002P-0122
|
| Request Rulemaking on Functional Foods & Establish Adv. Com.
|
|
|
|
|
| C 7
|
| Rejuvenative Foods
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 15
|
| American Beverage Association
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 16
|
| AHPA
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 17
|
| Ms. Andrea Bruce
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 18
|
| International Dairy Foods Association
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 19
|
| International Dairy Foods Association
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 20
|
| GMA/FPA
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 21
|
| ILSI North America
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 22
|
| Burdock Group
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 23
|
| Hogan
|
| Vol #:
|
| 2
|
|
|
|
|
| 2002V-0230
|
| Laser Light Show, Laser Fantasy International-Rainbow I Proj
|
|
|
|
|
| VRA 2
|
| FDA/CDRH to Montgomery County Public Works
|
| Vol #:
|
| 1
|
|
|
|
|
| 2002V-0347
|
| Laser light show
|
|
|
|
|
| VRA 2
|
| FDA/CDRH to Technological Artisans Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
|
|
|
|
| C 495
|
| R. Kasihskas + 37 signatures
|
| Vol #:
|
| 41
|
|
|
|
|
| C 496
|
| E. Theander
|
| Vol #:
|
| 41
|
|
|
|
|
| C 497
|
| D. Trevorrow
|
| Vol #:
|
| 41
|
|
|
|
|
| C 498
|
| C. Semento
|
| Vol #:
|
| 41
|
|
|
|
|
| C 499
|
| S. Klein
|
| Vol #:
|
| 41
|
|
|
|
|
| C 500
|
| M.Rowland
|
| Vol #:
|
| 41
|
|
|
|
|
| C 501
|
| L. Larson
|
| Vol #:
|
| 41
|
|
|
|
|
| C 502
|
| R. Vineyard
|
| Vol #:
|
| 41
|
|
|
|
|
| C 503
|
| N. Grove
|
| Vol #:
|
| 41
|
|
|
|
|
| C 504
|
| S. Simpler
|
| Vol #:
|
| 41
|
|
|
|
|
| C 505
|
| C. Bucciero
|
| Vol #:
|
| 41
|
|
|
|
|
| C 506
|
| E. Knazek
|
| Vol #:
|
| 41
|
|
|
|
|
| C 507
|
| S. Calaby
|
| Vol #:
|
| 41
|
|
|
|
|
| C 508
|
| P. Seely
|
| Vol #:
|
| 41
|
|
| | | | | | | | |
|
| |
|
| 2005N-0373
|
| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
|
|
|
|
|
| NEC 1
|
| FDA
|
| Vol #:
|
| 8
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| C 18285
|
| K. Tillson
|
| Vol #:
|
| 198
|
|
| |
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
|
|
| C 15
|
| Hoffmann-La Roche (Roche)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0062
|
| Expanded Access to Investigational Drugs for Treatment Use
|
|
|
|
|
| C 25
|
| C Nesgoda
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 99
|
| Public Citizen's Health Research Group
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 100
|
| Cancer Leadership Council
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 101
|
| Pendergast Consulting
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 102
|
| Cystic Fibrosis Foundation
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0525
|
| Supplements and Other Changes to an Approved Application
|
|
|
|
|
| C 5
|
| DSM Anti-Infectives B.V.
|
| Vol #:
|
| 1
|
|
| |
|
| 2006P-0094
|
| To undertake rulemaking to establish specific rules and regulations governing the definition of natural before a natural claim can be made on foods and beverages regulated by the FDA
|
|
|
|
|
|
|
|
|
|
|
| C 7
|
| Oregon Blueberry Commission
|
| Vol #:
|
| 2
|
|
|
|
|
| 2006P-0103
|
| ANDA Suitability for Temazepam Orally Disintegrating Tablets, 7.5 mg, 15 mg, 22.5 mg, and 30 mg
|
|
|
|
|
| WDL 1
|
| Lachman Consultant Services, Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0173
|
| Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product
|
|
|
|
|
|
|
|
|
|
|
| C 4
|
| University of Arizona
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0209
|
| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
|
|
|
|
|
| C 5
|
| Valeant Pharmaceutical International
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0403
|
| Determine whether an Abbreviated New Drug Application can be filed against the listed drug Novamine 15%, manufactured by Hospira under NDA 17-957
|
|
|
|
|
| WDL 1
|
| B. Braun Medical Inc.
|
| Vol #:
|
| 2
|
|
| |
|
| 2006P-0415
|
| Petition Seeking Regulation of Cloned Animals
|
|
|
|
|
| C 54
|
| I Druc
|
| Vol #:
|
| 6
|
|
|
|
|
| 2006P-0498
|
| Use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods
|
|
|
|
|
| C 89
|
| C Bubon
|
| Vol #:
|
| 1
|
|
|
|
|
| C 90
|
| D Rey
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2007D-0089
|
| Guidance for Industry and Review Staff on Target Product Profile A Strategic Development Process Tool
|
|
|
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2007D-0101
|
| Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
|
|
|
|
|
|
|
|
|
|
|
| EC 9
|
| Shreveport VA Medical Center/LSU
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 10
|
| Mr. Raymond Kostanty
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 11
|
| Ms. Kimberly Anderson
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 12
|
| Dr. James Gillespie
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 13
|
| Ms. Sophia Stewart
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 14
|
| Ochsner Medical Center
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0099
|
| New Drugs Exempted From Prescription-Dispensing Requirements; Technical Amendment
|
|
|
|
|
| NFR 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0105
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Mental Models Study of Food Bioterrorism Risk Awareness
|
|
|
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0065
|
| To increase print size of direct-to-consumer advertisements
|
|
|
|
|
| LET 1
|
| FDA/CDER to Pharmacists Planning Service, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| SUP 1
|
| Pharmacists Planning Service, Inc.
|
| Vol #:
|
| 1
|
|
| |
|
| 2007P-0124
|
| ANDA Suitability for clindamycin phosphate foam (non-aerosol), 1%
|
|
|
|
|
| ACK 1
|
| FDA / DDM to Olsson, Frank And Weeda, P. C.
|
| Vol #:
|
| 1
|
|
|
|
|
| CP 1
|
| Olsson, Frank And Weeda, P. C.
|
| Vol #:
|
| 1
|
|
