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| Dockets Entered
On October 31, 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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| 1986P-0314
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| ASPARTAME IMMINENT HAZARD
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| 2002D-0049
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| Disclosure of Conflicts of Interest for Special Gov, Employe
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| 2004D-0484
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| Guidance for Industry on the Role of HIV Drug Resistance Testing in Antiretroviral Drug Development
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| 2005D-0490
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| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
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| 2005V-0054
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| Laser LIGHT sHOW
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| 2007D-0201
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| Guidance for Industry and Food and Drug Administration Staff; Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents
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| 2007D-0364
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| Impact-Resistant Lenses: Questions and Answers Guidance
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| 2007E-0423
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| Patent Extension Application for Altabax (retapamulin) ,U.S. Patent No. RE39,128E
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| 2007E-0424
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| Patent Extension Application for LUCENTIS (ranibizumab), U.S. Patent No. 6,407,213
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| 2007E-0425
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| Patent Extension Application for LUCENTIS (ranibizumab), U.S. Patent No. 6,884,879
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| 2007E-0426
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| Patent Extension Application for Soliris (Eculizumab), U.S. Patent No. 6,355,245
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| 2007N-0182
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Databank
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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-0264
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| Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma, Direct Final Rule
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| 2007N-0284
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| Revision of the Requirements for Live Vaccine Processing
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| 2007N-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| 2007N-0389
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| Granisetron Hydrochloride Injection and 180-day generic drug exclusivity
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| 2007P-0282
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| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
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| 2007P-0301
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| Alkaline and Earth Alkaline Citrates and Osteoporosis; Health Claim Petition
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| 2007P-0331
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| Ban Use of Mercury In Medicine,UNLESS Proven Toxicologically Safe to the CGMP Standard Sufficiently Nontoxic
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| 2007P-0428
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| Abbreviated New Drug Application (ANDA) suitable for diclofenac sodium and misoprostol, in respective combinations of 50 mg/200 mcg and 75 mg/200 mcg
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| 1978N-0038
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| Sunscreen Drug Products
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| EC 2465
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| Ms. Karen Costopoulos
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| Vol #:
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| 162
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| EC 2466
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| Mrs. Mary Flannery
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| Vol #:
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| 162
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| EC 2467
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| Mr. Joshua Amberg
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| Vol #:
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| 162
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| EC 2468
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| Ms. Bridget Sevigny
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| Vol #:
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| 162
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| EC 2469
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| Mrs. Chris Geil
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| Vol #:
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| 162
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| EC 2470
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| Ms. Monica Bentz
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| Vol #:
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| 162
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| EC 2471
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| Mr. Greg Sutherland
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| Vol #:
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| 162
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| EC 2472
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| Ms. Jain Irvine
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| Vol #:
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| 162
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| EC 2473
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| Ms. Wendy Brown
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| Vol #:
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| 162
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| EC 2474
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| Mr. Jan Schweinfurth
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| Vol #:
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| 162
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| EC 2475
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| Mrs. Brenda Bural
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| Vol #:
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| 162
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| EC 2476
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| Mrs. Mary Hills
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| Vol #:
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| 162
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| EC 2477
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| Ms. Susan Kusz
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| Vol #:
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| 162
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| EC 2478
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| Ms. Margaret Caldwell
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| Vol #:
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| 162
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| EC 2479
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| Mrs. Marijean Dornback
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| Vol #:
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| 162
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| EC 2480
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| Mr. Bill Harris
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| Vol #:
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| 162
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| EC 2481
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| Ms. Leslie Okaldek
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| Vol #:
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| 162
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| EC 2482
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| Ms. Allison Shurr
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| Vol #:
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| 162
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| EC 2483
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| N/A
|
| Vol #:
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| 162
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| |
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| EC 2484
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| Mrs. Cindy Christensen
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| Vol #:
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| 162
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| EC 2485
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| Ms. Lianne Labossiere
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| Vol #:
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| 162
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| EC 2486
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| Mrs. Samantha Leible
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| Vol #:
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| 162
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| EC 2487
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| CIBA
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| Vol #:
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| 162
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| EC 2488
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| Mr. Mark McCusker
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| Vol #:
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| 162
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| EC 2489
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| Mr. Tom Bianchi
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| Vol #:
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| 162
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| EC 2490
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| Mr. Matthew Leible
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| Vol #:
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| 162
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| EC 2491
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| Wackenhut Services, Inc.
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| Vol #:
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| 162
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| EC 2492
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| Mr. Edward Holland
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| Vol #:
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| 162
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| EC 2493
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| Mr. Raymond DePlatchett
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| Vol #:
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| 162
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| EC 2494
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| CIBA Specialty Chemicals
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| Vol #:
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| 162
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| EC 2495
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| CIBA
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| Vol #:
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| 162
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| EC 2496
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| Mrs. Stacey Crosby
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| Vol #:
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| 162
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| EC 2497
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| Ms. Jennifer Leary
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| Vol #:
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| 162
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| EC 2498
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| Ciba Specilty Chemicals
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| Vol #:
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| 162
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| |
|
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| EC 2499
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| Mr. Philip Ford
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| Vol #:
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| 162
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| EC 2500
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| Mr. Joey McNeill
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| Vol #:
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| 162
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| EC 2501
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| Mr. Robert Jones
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| Vol #:
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| 162
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| EC 2502
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| Mr. William Farrington
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| Vol #:
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| 162
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| EC 2503
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| Ms. Deborah Mills
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| Vol #:
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| 162
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| EC 2504
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| CIBA
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| Vol #:
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| 162
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| EC 2505
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| Ms. Linda SnyderAllen
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| Vol #:
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| 162
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| EC 2506
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| Mrs. Bonnie Moss
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| Vol #:
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| 162
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| |
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| EC 2507
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| Mr. Clatis Becton
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| Vol #:
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| 162
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| |
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| EC 2508
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| Mrs. Crystal James
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| Vol #:
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| 162
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| EC 2509
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| Miss. Donna Scudieri
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| Vol #:
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| 162
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| |
|
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| EC 2510
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| Ms. Deborah Dalley
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| Vol #:
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| 162
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| |
|
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| EC 2511
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| Ciba Specialty Chemicals
|
| Vol #:
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| 162
|
|
| | | | | | | |
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| |
|
| EC 2512
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| Mrs. Andreea Sparhawk
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| Vol #:
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| 162
|
| |
|
|
| EC 2513
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| Dr. Liliana Craciun
|
| Vol #:
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| 162
|
| |
|
|
| EC 2514
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| CIBA
|
| Vol #:
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| 162
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| |
|
|
| EC 2515
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| CIBA
|
| Vol #:
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| 162
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| |
|
|
| EC 2516
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| Ms. Lindsay Echternach
|
| Vol #:
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| 162
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| |
|
|
| EC 2517
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| Mr. Rickey Giles
|
| Vol #:
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| 162
|
| |
|
|
| EC 2518
|
| Mr. Rory Price
|
| Vol #:
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| 162
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| |
|
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| EC 2519
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| Mr. Bill Newberry
|
| Vol #:
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| 162
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|
|
| EC 2520
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| Mr. Jeff Crabtree
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| Vol #:
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| 162
|
| |
|
|
| EC 2521
|
| Mrs. Susan Snead
|
| Vol #:
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| 162
|
| |
|
|
| EC 2522
|
| Mr. Jeffrey Collis
|
| Vol #:
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| 162
|
| |
|
|
| EC 2523
|
| Mr. Bret Bement
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2524
|
| Mr. Quinton Simison
|
| Vol #:
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| 162
|
| |
|
|
| EC 2525
|
| Mr. Michael Imwalle
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2526
|
| CIBA Specialty Chemicals
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2527
|
| Mr. Juan Capote
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2528
|
| Dr. Olga Dueva-Koganov
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2529
|
| Mr. Kenneth Coppridge
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2530
|
| Miss. Irene Sy
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2531
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| CIBA
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2532
|
| Mr. Christopher Holodak
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2533
|
| Mr. Don Smith
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2534
|
| Ms. Ashley Rice
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2535
|
| Mr. Scott Hansen
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2536
|
| Mr. Anthony DiBattista
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2537
|
| Mrs. Arlene Orofino
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2538
|
| CIBA
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2539
|
| Mr. Jeff Mundell
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2540
|
| CIBA
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2541
|
| Mr. Darrin Behrens
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2542
|
| Mr. John DiStefano
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2543
|
| Mr. Chris Callahan
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2544
|
| Dr. Malcolm De Leo
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2545
|
| Mr. Don Ivey
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2546
|
| Mr. John Butterfield
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2547
|
| CIBA
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2548
|
| Mrs. Beth McCall
|
| Vol #:
|
| 162
|
|
| | | | | | | |
|
| |
|
| EC 2549
|
| Ms. Sandra Tan
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2550
|
| CIBA
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2551
|
| Ms. Colleen Whalen
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2552
|
| Mr. Kerry McCall
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2553
|
| Ms. Donna Jakubowski
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2554
|
| Mr. Michael Brown
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2555
|
| Dr. Marc Mamak
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2556
|
| Ms. D Zdanowski
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2557
|
| Ms. Brenda White
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2558
|
| Mr. John verdi
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2559
|
| CIBA Specialty Chemicals
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2560
|
| Ms. Jeanne Taylor
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2561
|
| Mr. James Nisco
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2562
|
| Dr. Kai Su
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2563
|
| Mr. Wayne Mockel
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2564
|
| CIBA
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2565
|
| Mr. Paul Farwig
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2566
|
| Mr. Chris Wells
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2567
|
| Miss. Tara Ferrell
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2568
|
| Mr. Christopher Squier
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2569
|
| Mr. John Weaver
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2570
|
| Dr. Eugene Scanlon
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2571
|
| Mr. Dan Reilly
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2572
|
| Dr. Anthony DeBellis
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2573
|
| Mr. James Craig
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2574
|
| Mr. Peter Skrobot
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2575
|
| Ciba Specialty Chemicals
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2576
|
| Mr. John Miller
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2577
|
| Ms. David Nash
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2578
|
| Mr. Daniel Bernstein
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2579
|
| Ms. Christine Verdi
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2580
|
| Mr. Melvin Badon
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2581
|
| Dr. Gary Fairley
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2582
|
| Mrs. Catherine Dowd
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2583
|
| Dr. Brian Bakke
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2584
|
| Mrs. Bea Kuckens
|
| Vol #:
|
| 162
|
| |
|
|
| EC 2585
|
| Mr. John Girard
|
| Vol #:
|
| 162
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| EC 2586
|
| Ms. Karen Wagner
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2587
|
| PolyAd Services
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2588
|
| Mr. Rickey Bazelle, Sr.
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2589
|
| Mr. Andrew Blotky
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2590
|
| Mr. Matthew Hendrix
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2591
|
| Ms. Rosemary Mitchell
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2592
|
| Ms. Carolyn Steinwedel
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2593
|
| Ms. Jean Zappia
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2594
|
| Mr. James Copson
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2595
|
| Ms. Dawn Phillips
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2596
|
| Mr. Casey Cordon
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2597
|
| Ms. Carolyn Holmes
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2598
|
| Mr. Billy Kirtley
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2599
|
| Diversified Staffing Group
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2600
|
| Ms. Liesl Lim
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2601
|
| Mr. Joshua Kretman
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2602
|
| Mr. Darryl Godinez
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2603
|
| Ms. Elizabeth Hastings
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2604
|
| Ms. Anitha Reddy
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2605
|
| Mr. Geoffrey Swenson Swenson
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2606
|
| Stanford Law School
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2607
|
| Mr. Brett Rajkumar
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2608
|
| Ms. Mary Stokes
|
| Vol #:
|
| 162
|
|
|
|
|
| EC 2609
|
| Mrs. Briana Walker
|
| Vol #:
|
| 162
|
|
|
|
|
| EREG 9
|
| C. McCracken
|
| Vol #:
|
| 162
|
|
|
|
|
| EXT 15
|
| Unilever
|
| Vol #:
|
| 162
|
|
|
|
|
| EXT 16
|
| Estee Lauder Companies
|
| Vol #:
|
| 162
|
|
|
|
|
| EXT 17
|
| Elizabeth Arden, Inc
|
| Vol #:
|
| 162
|
|
|
|
|
| 1986P-0314
|
| ASPARTAME IMMINENT
HAZARD
|
|
|
|
|
| C 25
|
| Mission Possible International
|
| Vol #:
|
| 2
|
|
|
|
|
| 2002D-0049
|
| Disclosure of Conflicts
of Interest for Special Gov, Employe
|
|
|
|
|
| GDL 2
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
|
| | | | | | | | |
|
| |
|
| 2004D-0484
|
| Guidance for Industry on the Role of HIV Drug Resistance Testing in Antiretroviral Drug Development
|
| |
|
|
| GDL 2
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD 2
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2005D-0062
|
| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
|
| |
|
|
| EC 38
|
| Stanford Law School
|
| Vol #:
|
| 2
|
| |
|
|
| 2005D-0490
|
| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
|
| |
|
|
| ANS 6
|
| FDA/CFSA to Allergy Grocer aka Miss Roben's
|
| Vol #:
|
| 1
|
| |
|
|
| ANS 7
|
| FDA/CFSAN to Franklin Baker, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| ANS 8
|
| FDA/CFSAN to Franklin Baker Co.
|
| Vol #:
|
| 1
|
| |
|
|
| ANS 9
|
| FDA/CFSAN to Franklin Baker Co.
|
| Vol #:
|
| 1
|
| |
|
|
| ELET 6
|
| Allergy Grocer aka Miss Roben's
|
| Vol #:
|
| 1
|
| |
|
|
| ELET 7
|
| Franklin Baker, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| ELET 8
|
| Franklin Baker, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| ELET 9
|
| Franklin Baker Co.
|
| Vol #:
|
| 1
|
| |
|
|
| 2005V-0054
|
| Laser LIGHT sHOW
|
| |
|
|
| LET 1
|
| David J. Olive
|
| Vol #:
|
| 1
|
| |
|
|
| 2007D-0201
|
| Guidance for Industry and Food and Drug Administration Staff; Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents
|
| |
|
|
| C 6
|
| Arrow International
|
| Vol #:
|
| 1
|
| |
|
|
| 2007D-0364
|
| Impact-Resistant Lenses: Questions and Answers Guidance
|
| |
|
|
| EC 1
|
| COLTS Laboratories
|
| Vol #:
|
| 1
|
| |
|
|
| 2007E-0423
|
| Patent Extension Application for Altabax (retapamulin) ,U.S. Patent No. RE39,128E
|
| |
|
|
| APP 1
|
| GlaxoSmithKline
|
| Vol #:
|
| 1
|
| |
|
|
| LET 1
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
| |
|
|
| 2007E-0424
|
| Patent Extension Application for LUCENTIS (ranibizumab), U.S. Patent No. 6,407,213
|
| |
|
|
| APP 1
|
| Genetech, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| LET 1
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
| |
|
|
| 2007E-0425
|
| Patent Extension Application for LUCENTIS (ranibizumab), U.S. Patent No. 6,884,879
|
| |
|
|
| APP 1
|
| Genentech, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| LET 1
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
| |
|
|
| 2007E-0426
|
| Patent Extension Application for Soliris (Eculizumab), U.S. Patent No. 6,355,245
|
| |
|
|
| APP 1
|
| Alexion Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| LET 1
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0182
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Databank
|
|
|
|
|
|
| | |
|
|
| EC 2
|
| Mr. David Morgan
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0262
|
| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
|
| |
|
|
| EC 6
|
| Mr. Kie Watkins
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0264
|
| Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma, Direct Final Rule
|
| |
|
|
| EC 3
|
| PPTA
|
| Vol #:
|
| 1
|
| |
|
|
| EC 4
|
| AABB Interorganizational Plasma Task Force
|
| Vol #:
|
| 1
|
| |
|
|
| EC 5
|
| AABB, Department of Regulatory Affairs
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0284
|
| Revision of the Requirements for Live Vaccine Processing
|
| |
|
|
| REF 1
|
| Diane Sullivan
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0356
|
| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
|
| |
|
|
| EAPE 209
|
| J&J Merck
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 210
|
| Johnson & Johnson Consumer Group
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 211
|
| McNeil Consumer Healthcare
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 212
|
| FDAAdvisoryCommittee.com
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 213
|
| NCPA
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 214
|
| National Community Pharmacists Assoc
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 215
|
| Howard University, School of Pharmacy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 216
|
| Food and Drug Administration
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 217
|
| Food and Drug Administration
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 218
|
| Howard University
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 219
|
| BAYER HEALTHCARE LLC
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 220
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 221
|
| Francesco International
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 222
|
| Eli Lilly
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 223
|
| Novo Nordisk
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 224
|
| Novo Nordisk Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 225
|
| CONCENTRICS RESEARCH
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 226
|
| NABP
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 227
|
| National Alliance of State Pharmacy Associations
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 228
|
| National Alliance of State Pharmacy Associations
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 229
|
| National Alliance of State Pharmacy Associations
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| EAPE 230
|
| Greenberg Traurig
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 231
|
| Perrigo Company
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 232
|
| Ketchum
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 233
|
| American Pharmacists Association
|
| Vol #:
|
| 1
|
| |
|
|
| EC 26
|
| The Pharmacy Alliance
|
| Vol #:
|
| 1
|
| |
|
|
| EC 27
|
| Dr. Brent Chan
|
| Vol #:
|
| 1
|
| |
|
|
| EC 28
|
| Dr. Daniel Ginsberg
|
| Vol #:
|
| 1
|
| |
|
|
| EC 29
|
| Mrs. S Bates
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0389
|
| Granisetron Hydrochloride Injection and 180-day generic drug exclusivity
|
| |
|
|
| C 2
|
| A. Tsien
|
| Vol #:
|
| 1
|
| |
|
|
| EC 1
|
| Baxter Healthcare Corporation
|
| Vol #:
|
| 1
|
|
| |
|
| 2007P-0282
|
| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
|
| |
|
|
| EC 69
|
| Mr. Jeffrey Collis
|
| Vol #:
|
| 1
|
| |
|
|
| EC 70
|
| Stanford Law School
|
| Vol #:
|
| 1
|
| |
|
|
| EC 71
|
| Mr. Christopher Kramer
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0301
|
| Alkaline and Earth Alkaline Citrates and Osteoporosis; Health Claim Petition
|
| |
|
|
| PDN 1
|
| B. Schneeman FDA/CSFAN/ONLDS
|
| Vol #:
|
| 3
|
| |
|
|
| 2007P-0331
|
| Ban Use of Mercury In Medicine,UNLESS Proven Toxicologically Safe to the CGMP Standard Sufficiently Nontoxic
|
| |
|
|
| EC 5
|
| Mr. Michael Novakowski
|
| Vol #:
|
| 2
|
| |
|
|
| 2007P-0428
|
| Abbreviated New Drug Application (ANDA) suitable for diclofenac sodium and misoprostol, in respective combinations of 50 mg/200 mcg and 75 mg/200 mcg
|
| |
|
|
| ACK 1
|
| FDA/DDM to King and Spalding LLP
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| King and Spalding LLP
|
| Vol #:
|
| 1
|
|
|
