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| Dockets Entered
On August 29, 2006
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| Docket #
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| Title
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| 1978N-0065
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| Skin Bleaching Drug Products
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutrition
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| 2002F-0316
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| Safe Use of Mix of Bacteriofages/Antimicrobial Agent
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| 2005P-0205
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| Revise Drug Labeling for Adverse Event of Tendonopathy and Tendon Rupture
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| 2006E-0355
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| Patent Extension Application for AMITIZA (lubiprostone), U.S. Patent No. 5,284,858
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| 2006E-0356
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| Patent Extension Application for BARACLUDE (entecavir), U.S. Patent No. 5,206,244
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| 2006M-0294
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| P050017 - Zilver Vascular Stent
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| 2006N-0292
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| Unique Device Identification
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| 2006N-0327
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee and Modernization Act Small Business Qualification Certification (Form FDA 3602)
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| 2006P-0090
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| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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| 2006P-0286
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| Determine Whether Phoslo (calcium acetate) Capsules eq169 mg calcium have been voluntarily withdrawn from sale for safety or effcacy reasons.
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| 2006P-0360
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| Determine that the discontinued formulation of Carbocaine Injection, 3% supplied in 1.8 mL cartridge was not discontinued for safety and efficacy reasons
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| 1978N-0065
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| Skin Bleaching Drug Products
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| BKG 1
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| Background Material
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| 13
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| NPR 3
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| FDA
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| Vol #:
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| 4
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutrition
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| C 123
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| Cosmetic, Toiletry, and Fragrance Association (CTFA)
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| Vol #:
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| 10
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| EC 398
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| National Milk Producers Federation
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| Vol #:
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| 11
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| EC 399
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| American Association of Exporters and Importers
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| Vol #:
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| 11
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| EC 400
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| National Consumers League
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| Vol #:
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| 11
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| EC 401
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| National Yogurt Association
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| Vol #:
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| 11
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| EC 402
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| Food Animal Concerns Trust
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| Vol #:
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| 11
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| EC 403
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| Food Products Association
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| Vol #:
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| 11
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| EC 404
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| International Dairy Foods Association
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| Vol #:
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| 11
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| EC 405
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| Fresh Produce Association of the Americas
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| Vol #:
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| 11
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| 2002F-0316
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| Safe Use of Mix of Bacteriofages/Antimicrobial Agent
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| BKG 1
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| Backgroung Material
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| Vol #:
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| 2
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| | | | | | | | |
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| BKG 1
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| Background Material
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| Vol #:
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| 2
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| 2005P-0205
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| Revise Drug Labeling for Adverse Event of Tendonopathy and Tendon Rupture
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| SUP 1
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| Office of Illinois Attorney General
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| Vol #:
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| 1
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| C 18079
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| P. Randall
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| Vol #:
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| 196
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| C 18080
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| C. Dallas
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| Vol #:
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| 196
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| C 18081
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| Y. Curri
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| Vol #:
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| 196
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| C 18082
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| D. Stevens
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| Vol #:
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| 196
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| C 18083
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| M. Hosler
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| Vol #:
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| 196
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| C 18084
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| J. Glackin-Sedwick
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| Vol #:
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| 196
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| C 18085
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| J. Willow
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| Vol #:
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| 196
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| C 18086
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| M. Lohman
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| Vol #:
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| 196
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| C 18087
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| D. Lohman
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| Vol #:
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| 196
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| C 18088
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| W. Argersinger
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| Vol #:
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| 196
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| GDL 1
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| Guidance
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| Vol #:
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| 1
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| NAD 1
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| FDA
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| Vol #:
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| 1
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| 2006E-0355
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| Patent Extension Application for AMITIZA (lubiprostone), U.S. Patent No. 5,284,858
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| APP 1
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| Sucampo AG
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| Vol #:
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| 1
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| LET 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0356
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| Patent Extension Application for BARACLUDE (entecavir), U.S. Patent No. 5,206,244
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| APP 1
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| Bristol-Myers Squibb Company
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| Vol #:
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| 1
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| LET 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006M-0294
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| P050017 - Zilver Vascular Stent
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| CR 1
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| Cook, Inc.
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| Vol #:
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| 1
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| 2006N-0292
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| Unique Device Identification
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| EC 15
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| HCL Technologies Ltd.
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| Vol #:
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| 1
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| 2006N-0327
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee and Modernization Act Small Business Qualification Certification (Form FDA 3602)
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| N 1
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| FDA
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| Vol #:
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| 1
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| N 2
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| FDA
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| Vol #:
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| 1
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| 2006P-0090
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| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
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