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| Dockets Entered
On January 7, 2008
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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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| 1994D-0025
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| Guidelines on the Voluntary Labeling Milk & Milk Products from Cows That Have Not Been Treated with rbSt or rbGH
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2005P-0433
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| Adoption of Harmonization Policy by the U.S. Codex Delegation and US Policy in harmony with DSHEA and 19 U.S.C. 3512
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| 2006N-0466
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| Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2007D-0364
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| Impact-Resistant Lenses: Questions and Answers Guidance
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| 2007D-0367
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| Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval
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| 2007D-0419
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| Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Draft Guidance
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| 2007H-0433
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| Civil Money Penalty; Advanced Bionics Corporation
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| 2007N-0280
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| Amendment to the CGMP Regulations for Finished Pharmaceuticals
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| 2007N-0485
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| Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Food and Drug Administration Approval to Market a New Drug
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| 2007N-0487
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| Meeting being planned to obtain public input for ensuring the safety of pet food
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| 2007N-0489
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| Request for Comments on the Science and Technology Report; Establishment of Docket; Request for Comments
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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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| 2008P-0006
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| To determine whether Didrex 25 mg (benzphetmine hydrochloride) Tablets (NDA 12-427) by Pharmacia and Upjohn Company, has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
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| 2008P-0010
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| Over-the-Counter (OTC) Pertaining to Cough/Cold Drug Products Containg Tannates
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| 2008V-0008
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| Laser Light Show
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| 1978N-0038
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| Sunscreen Drug Products
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| C 726
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| Duke Surgery, Duke University Medical Center
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| Vol #:
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| 182
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| 1994D-0025
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| Guidelines on the Voluntary Labeling Milk & Milk Products from Cows That Have Not Been Treated with rbSt or rbGH
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| ANS 12
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| FDA/Executive Secretariat to Robert & Mary Fuhs
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| Vol #:
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| 71
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 21271
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21272
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21273
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21274
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21275
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21276
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21277
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21278
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21279
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21280
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21281
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21282
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21283
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21284
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21285
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21286
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21287
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21288
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21289
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21290
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21291
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21292
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21293
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21294
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21295
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| Isaac Marcum
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| Vol #:
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| 183
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| 2005P-0433
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| Adoption of Harmonization Policy by the U.S. Codex Delegation and US Policy in harmony with DSHEA and 19 U.S.C. 3512
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| C 9
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| Natural Solutions Foundation
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| Vol #:
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| 2
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| C 10
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| Natural Solutions Foundation
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| Vol #:
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| 3
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| C 11
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| Natural Solutions Foundation
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| Vol #:
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| 4
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| C 12
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| Natural Solutions Foundation
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| Vol #:
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| 5
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| C 13
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| Natural Solutions Foundation
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| Vol #:
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| 6
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| 2006N-0466
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| Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
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| EREG 1
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| J. Breen
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| Vol #:
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| 1
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| C 525
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| D. Baker
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| Vol #:
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| 14
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| 2007D-0364
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| Impact-Resistant Lenses: Questions and Answers Guidance
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| EC 16
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| Spectacles
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| Vol #:
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| 1
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| EC 17
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| Professional Optician of Florida
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| Vol #:
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| 1
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| EC 18
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| Mr. Alan Rubin
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| Vol #:
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| 1
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| EC 19
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| Durham Optical
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| Vol #:
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| 1
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| EC 20
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| Professional Opticians of Florida
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| Vol #:
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| 1
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| EC 21
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| Mr. Gary Harris
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| Vol #:
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| 1
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| 2007D-0367
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| Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval
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| NEC 1
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| FDA
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| Vol #:
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| 1
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| 2007D-0419
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| Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Draft Guidance
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| C 1
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| Sanofi Aventis
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| Vol #:
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| 1
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| 2007H-0433
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| Civil Money Penalty; Advanced Bionics Corporation
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| CS 2
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| FDA/DDM
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| Vol #:
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| 1
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| OR 2
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| FDA/Administrative Law Judge
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| Vol #:
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| 1
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| 2007N-0280
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| Amendment to the CGMP Regulations for Finished Pharmaceuticals
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| EREG 1
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| M. Jornitz
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| Vol #:
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| 1
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| 2007N-0485
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| Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Food and Drug Administration Approval to Market a New Drug
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| |
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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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| 2007N-0487
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| Meeting being planned to obtain public input for ensuring the safety of pet food
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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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| 2007N-0489
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| Request for Comments on the Science and Technology Report; Establishment of Docket; Request for Comments
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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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| 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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|
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| EC 12
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| Fresno City College Student
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| Vol #:
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| 2
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|
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| 2008P-0006
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| To determine whether Didrex 25 mg (benzphetmine hydrochloride) Tablets (NDA 12-427) by Pharmacia and Upjohn Company, has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
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|
|
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| |
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| ACK 1
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| FDA/ DDM to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| CP 1
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2008P-0010
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| Over-the-Counter (OTC) Pertaining to Cough/Cold Drug Products Containg Tannates
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| ACK 1
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| FDA/ DDM to Tannates Working Group
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| Vol #:
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| 1
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| CP 1
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| Tannates Working Group
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| Vol #:
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| 1
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| 2008V-0008
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| Laser Light Show
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| ACK 1
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| FDA/ DDM to See Touring Productions, Inc.
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| Vol #:
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| 1
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| VAR 1
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| See Touring Productions, Inc.
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| Vol #:
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| 1
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