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| Dockets Entered
On October 12, 2007
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| Docket #
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| Title
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| 1978N-0038
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| Sunscreen Drug Products
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| 1998D-0077
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| Treatment of osteoarthritis/drugs, devices and biological pt
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| 2005P-0358
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| Determine that sponsors of human drug applications for positron emission tomography (PET) drug be exempt from paying certain user fees assessed pursuant to the prescription drug.
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| 2006N-0362
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| General & Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| 2007D-0249
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| Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
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| 2007D-0252
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| Guidance for Industry and Food and Drug Administration Staff; Pulse Oximeters - Premarket Notification Submissions 510(k)s
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| 2007D-0266
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| International Conference on Harmonisation; Draft Guidance on Q10 Pharmaceutical Quality System
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| 2007D-0309
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes
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| 2007N-0262
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
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| 2007N-0299
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| Proposal to Debar Allyn M. Norman, D.O.
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| 2007N-0311
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| Midodrine Exclusivity Issues
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| 2007N-0330
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| Presidential Interagency Working Group on Import Safety; Public Meeting
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| 2007N-0347
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| Information Technology Strategic Planning; Public Meeting
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| 2007N-0356
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| Behind The Counter Availability
of Certain Drugs; Public Meeting
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| 2007P-0074
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| Over-the-Counter (OTC) Cough and Cold Drug Products for Children Under 6 Years of Age
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| 2007P-0097
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| Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
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| 2007P-0140
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| Stay final approval and/or effective date of final approval of any 0.4. mg Norethindrone and 35 microgram Ethinyl Estradiol oral chewable tablet product ANDAs unless there is pharmaceutical e
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| 2007P-0142
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| Incorporate the full proprietary name Zanaflex Capsules, intead of the truncated form of the name Zanaflex
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| 2007P-0147
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| Use of the Term Natural Consistent with USDA's Food Safety and Inspection Service
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| 2007P-0158
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| Patent Listing and Market Exclusivity for Combination Drugs When One Component is a pre-1997 Antibiotic Ingredient
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| 2007P-0320
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| Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
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| 1978N-0038
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| Sunscreen Drug Products
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| EREG 3
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| D. Tashjian
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| Vol #:
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| 155
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| EXT 11
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| Cosmetic, Toiletry, and Fragrance Association (CTFA)
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| Vol #:
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| 156
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| SUP 52
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| Immediate Trial
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| Vol #:
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| 59
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| 1998D-0077
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| Treatment of osteoarthritis/drugs, devices and biological pt
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| C 17
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| Fidia Farmaceutici, S.p.A. (Fidia)
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| Vol #:
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| 1
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| C 18
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| Osteoarthritis Research Society International (OARSI)
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| Vol #:
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| 1
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| 2005P-0358
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| Determine that sponsors of human drug applications for positron emission tomography (PET) drug be exempt from paying certain user fees assessed pursuant to the prescription drug.
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| WDL 1
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| FDA/CDER to Hyman, Phelps & McNamara, P.C.
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| Vol #:
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| 1
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| 2007D-0249
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| Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
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| C 2
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| Hogan and Hartson, LLP
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| 1
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| C 3
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| American Academy of Orthopaedic Surgeons (AAOS)
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| Vol #:
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| 1
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| C 4
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| AdvaMed
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| Vol #:
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| 1
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| 2007D-0252
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| Guidance for Industry and Food and Drug Administration Staff; Pulse Oximeters - Premarket Notification Submissions 510(k)s
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| EC 2
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| Covidien / Nellcor
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| Vol #:
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| 1
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| 2007D-0266
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| International Conference on Harmonisation; Draft Guidance on Q10 Pharmaceutical Quality System
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| C 1
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| R. Gural
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| Vol #:
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| 1
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| C 2
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| R. Wolgemuth
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| Vol #:
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| 1
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| EC 9
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| Int'l Society for Pharmaceutical Engineering
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| Vol #:
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| 1
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| EC 10
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| Int'l Society for Pharmaceutical Engineering
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| Vol #:
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| 1
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| EC 11
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| Biotechnology Industry Organization
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| Vol #:
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| 1
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| EC 12
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| Boehringer Ingelheim Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2007D-0309
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes
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| NCR 1
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| FDA
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| Vol #:
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| 1
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| 2007N-0262
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
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| EC 3
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| Mrs. Joan O'Keefe
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| Vol #:
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| 1
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| 2007N-0299
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| Proposal to Debar Allyn M. Norman, D.O.
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| LET 1
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| J. Woodcock
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| Vol #:
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| 1
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| 2007N-0311
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| Midodrine Exclusivity Issues
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| C 5
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| Upsher-Smith Laboratories, Inc.
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| Vol #:
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| 1
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| 2007N-0330
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| Presidential Interagency Working Group on Import Safety; Public Meeting
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| C 23
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| Food & Water Watch
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| Vol #:
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| 1
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| C 24
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| APPMA
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| Vol #:
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| 1
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| 2007N-0347
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| Information Technology Strategic Planning; Public Meeting
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| EC 11
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| Octagon Research Solutions
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| Vol #:
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| 1
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| |
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| 2007N-0356
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| Behind The Counter
Availability of Certain Drugs; Public Meeting
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| EAPE 93
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| Evelyn, Brenda
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| Vol #:
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| 1
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| EAPE 94
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| Warren, Thomas
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| Vol #:
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| 1
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| EAPE 95
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| de los Reyes, Lori
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| Vol #:
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| 1
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| EAPE 96
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| Smith, Juliana
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| Vol #:
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| 1
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| EAPE 97
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| Drais , Bobbi
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| Vol #:
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| 1
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| EAPE 98
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| Mendelsohn, Aaron
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| Vol #:
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| 1
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| EAPE 99
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| Neumann, Stephen
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| Vol #:
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| 1
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| EAPE 100
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| Garvin, Cheri
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| Vol #:
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| 1
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| EC 6
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| Dr. Daniele Fisher
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| Vol #:
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| 1
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| 2007P-0074
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| Over-the-Counter (OTC) Cough and Cold Drug Products for Children Under 6 Years of Age
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| C 1
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| Brian Kaplan
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| Vol #:
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| 1
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| EC 4
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| Mrs. Catherine Story
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| Vol #:
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| 1
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| EC 5
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| Mrs. Angela Olson
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| Vol #:
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| 1
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| 2007P-0097
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| Issue
a new regulation wine product the composition of wine , water, sugar,
with or without flavorings and an alcohol content of less than 75% can
not be marketed or sold with a wine varietal designation
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| C 12
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| RagApple Lassie Vineyards
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| Vol #:
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| 1
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| C 13
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| RagApple Lassie Vineyards
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| Vol #:
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| 1
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| C 14
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| Heron Hill Winery
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| Vol #:
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| 1
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| C 15
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| Jay Somers
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| Vol #:
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| 1
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| 2007P-0140
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| Stay final approval
and/or effective date of final approval of any 0.4. mg Norethindrone
and 35 microgram Ethinyl Estradiol oral chewable tablet product ANDAs
unless there is pharmaceutical
|
|
|
|
|
|
| |
|
|
|
| LET 1
|
| FDA/CDER to Warner Chilcott, Inc.
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| Vol #:
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| 1
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| 2007P-0142
|
| Incorporate the full proprietary name Zanaflex Capsules, intead of the truncated form of the name Zanaflex
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| LET 1
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| FDA/CDER to Acorda Therapeutics, Inc.
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| Vol #:
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| 1
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| 2007P-0147
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| Use of the Term Natural Consistent with USDA's Food Safety and Inspection Service
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| LET 1
|
| Barbara O. Schneeman
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| Vol #:
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| 3
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| 2007P-0158
|
| Patent Listing and Market Exclusivity for Combination Drugs When One Component is a pre-1997 Antibiotic Ingredient
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|
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| SUP 1
|
| Arnold & Porter, LLP
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| Vol #:
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| 1
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| 2007P-0320
|
| Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
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| C 3
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| B. LaGreca
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| Vol #:
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| 1
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| C 4
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| D. Riley
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| Vol #:
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| 1
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