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| Dockets Entered
On November 27, 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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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2001P-0470
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| Establish Appropriate Approval Standards for Generic Clonidine Transdermal Products
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| 2004N-0217
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| Nutrient content claims: DHA, EPA, and ALA (Omega-3 Fatty Acids)
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| 2005D-0490
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| Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004; Guidance (Edition 2)
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| 2005P-0189
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| Nutrient content claims for ALA and DHA omega-3 fatty acids
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| 2006N-0168
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| Food Labeling: Reference Daily Intakes & Daily Reference Values
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| 2006P-0137
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| Nutrient Content Claim for EPA and DHA omega-3 fatty acids
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| 2006P-0210
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| Amend regulations for products composed of engineered nanoparticles generally and sunscreen drug products composed of engineered nanoparticles specifically
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| 2006P-0291
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| Determine whether Eloxatin (Oxaliplatin) has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
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| 2006P-0298
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| To permit an ANDA Suitability for Eloxatin (Oxaliplatin for injection)
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| 2006P-0299
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| Determine whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons
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| 2006P-0309
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| ANDA for ELOXATIN (oxaliplatin for injection) lyophilized powder for infusion, 50 mg and 100 mg vials
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| 2007D-0310
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| Companion to Guidance for Industry on Pharmacogenomic Data
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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-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| 2007N-0382
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| Ramipril Capsules and 180-day generic drug exclusivity
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| 2007P-0062
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| Determine Whether a Previously Listed Drug Eloxatin (oxaliplatin for injection) Lyophilized Powder for Infusion, 50 and 100 mg Vials Has Been Voluntarily Withdrawn From Sale for Safety or Efficacy Rea
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| 2007P-0178
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| Take action to subject certain cardiac surgery devices to premarket notification (510(k) requirements
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| 1978N-0038
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| Sunscreen Drug Products
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| C 677
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| Venable LLP
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| Vol #:
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| 164
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| C 678
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| The Assembly State of New York Albany
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| Vol #:
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| 164
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| C 679
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| Crown Laboratories, Inc.
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| Vol #:
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| 164
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| C 680
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| Crown Laboratories, Inc.
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| Vol #:
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| 164
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| C 681
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| Jack Lingo, Inc. Realtor
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| Vol #:
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| 164
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| C 682
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| Office of Insurance and Safety Fire commissioner
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| Vol #:
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| 164
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| C 683
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| Life Producs, Inc.
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| Vol #:
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| 164
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| C 684
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| Crown Laboratories, Inc.
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| Vol #:
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| 164
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| C 685
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| Swiss American
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| Vol #:
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| 164
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| C 686
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| Vera Wright
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| Vol #:
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| 164
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| C 687
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| M. Kingston
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| Vol #:
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| 164
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| C 688
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| Swiss American
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| Vol #:
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| 164
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| C 689
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| M. G. Greenberg, Ph. D.
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| Vol #:
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| 164
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| C 690
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| BASF The Chemical Company
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| Vol #:
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| 164
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| C 691
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| International Center for Technology Assessmnt
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| Vol #:
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| 165
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| C 692
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| Swiss American
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| Vol #:
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| 170
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| C 693
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| Dr. G. O. Telford
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| Vol #:
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| 170
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| EC 2685
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| German Society of Cosmetic Chemists - DGK
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| Vol #:
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| 164
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| EC 2686
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| German Society of Cosmetic Chemists - DGK
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| Vol #:
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| 164
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| EC 2687
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| German Society of Cosmetic Chemists - DGK
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| Vol #:
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| 164
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| EC 2688
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| Merck KGaA, Germany
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| Vol #:
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| 164
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| EC 2689
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| Venable, LLP
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| Vol #:
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| 164
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| EC 2690
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| Mrs. Laura Scolari
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| Vol #:
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| 164
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| EC 2691
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| American Association for Justice
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| Vol #:
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| 164
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| EC 2692
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| Ciba Corporation
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| Vol #:
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| 164
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| EC 2693
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| Merz Pharmaceuticals
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| Vol #:
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| 164
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| EC 2694
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| Northwestern University
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| Vol #:
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| 164
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| EC 2695
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| Citizens for Sun Protection
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| Vol #:
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| 164
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| EC 2696
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| Croda Inc
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| Vol #:
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| 164
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| EC 2697
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| Dr. John Dowdy
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| Vol #:
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| 164
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| EC 2698
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| Dr. John Dowdy
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| Vol #:
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| 164
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| EC 2699
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| Ms. Jennifer Sloan
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| Vol #:
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| 164
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| EC 2700
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| Rapid Precision Testing Laboratories
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| Vol #:
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| 164
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| EC 2701
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| Mr. Jonathan Keim
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| Vol #:
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| 164
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| EC 2702
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| Rapid Precision Testing Laboratories
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| Vol #:
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| 164
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| EC 2703
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| Rapid Precision Testing Laboratories
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| Vol #:
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| 164
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| EC 2704
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| Ms. Maxine Kingston
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| Vol #:
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| 164
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| EC 2705
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| Miss. Jessica Naden
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| Vol #:
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| 164
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| EC 2706
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| Ms. Honor Banvard
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| Vol #:
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| 164
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| EC 2707
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| Solar Light Company, Inc.
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| Vol #:
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| 164
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 21078
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| New Chapter, Inc.
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| Vol #:
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| 182
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| LET 21079
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| Planetary Herbals
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| Vol #:
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| 182
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| LET 21080
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| Planetary Herbals
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| Vol #:
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| 182
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| LET 21081
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| Planetary Herbals
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| Vol #:
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| 182
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| LET 21082
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| CCA Industries, Inc.
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| Vol #:
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| 182
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| LET 21083
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| Herbalist & Alchemist, Inc.
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| Vol #:
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| 182
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| LET 21084
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| Herbalist & Alchemist, Inc.
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| Vol #:
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| 182
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| LET 21085
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| Herbalist & Alchemist, Inc.
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| Vol #:
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| 182
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| LET 21086
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| ZeaVision, LLC
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| Vol #:
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| 182
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| LET 21087
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| Vita-Herbs, Inc.
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| Vol #:
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| 182
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| LET 21088
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| Vita-Herbs, Inc.
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| Vol #:
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| 182
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| LET 21089
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| Babener & Associates
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| Vol #:
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| 182
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| LET 21090
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| Cyanotech
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| Vol #:
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| 182
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| LET 21091
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| Cyanotech
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| Vol #:
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| 182
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| LET 21092
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| Enzymatic Therapy
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| Vol #:
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| 182
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| LET 21093
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| Enzymatic Therapy
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| Vol #:
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| 182
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| LET 21094
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| Enzymatic Therapy
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| Vol #:
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| 182
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| LET 21095
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| Enzymatic Therapy
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| Vol #:
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| 182
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| 2001P-0470
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| Establish Appropriate Approval Standards for Generic Clonidine Transdermal Products
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| BKG 1
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| FDA Advisory Committee
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| Vol #:
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| 2
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| 2004N-0217
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| Nutrient content claims: DHA, EPA, and ALA (Omega-3 Fatty Acids)
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| NPR 1
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| FDA
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| Vol #:
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| 3
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| REF 1
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| Reference
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| Vol #:
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| 4
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| 2005D-0490
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| Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004; Guidance (Edition 2)
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| ANS 14
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| FDA/CFSA to Taro Dram Inc.
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| Vol #:
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| 1
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| ELET 14
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| Taro Dream Inc.
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| Vol #:
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| 1
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| 2005P-0189
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| Nutrient content claims for ALA and DHA omega-3 fatty acids
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| NPR 1
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| FDA
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| Vol #:
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| 2
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| REF 1
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| Reference
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| Vol #:
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| 3
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| 2006N-0168
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| Food Labeling: Reference Daily Intakes & Daily Reference Values
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| C 1
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| The Association for Dressings & Sauces
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| Vol #:
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| 1
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| C 2
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| The Vinegar Institute
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| Vol #:
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| 1
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| 2006P-0137
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| Nutrient Content Claim for EPA and DHA omega-3 fatty acids
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| NPR 1
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| FDA
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| Vol #:
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| 1
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| REF 1
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| Reference
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| Vol #:
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| 2
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| 2006P-0210
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| Amend regulations for products composed of engineered nanoparticles generally and sunscreen drug products composed of engineered nanoparticles specifically
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| C 3
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| International Center for Technology Assessment
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| Vol #:
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| 5
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| 2006P-0291
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| Determine whether Eloxatin (Oxaliplatin) has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
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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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| 2006P-0298
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| To permit an ANDA Suitability for Eloxatin (Oxaliplatin for injection)
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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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| | | | | | | | |
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| 2006P-0299
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| Determine whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons
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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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| 2006P-0309
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| ANDA for ELOXATIN (oxaliplatin for injection) lyophilized powder for infusion, 50 mg and 100 mg vials
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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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| 2007D-0310
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| Companion to Guidance for Industry on Pharmacogenomic Data
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| EC 3
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| sanofi-aventis
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| Vol #:
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| 1
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| EC 4
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| Merck Serono International S.A.
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| Vol #:
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| 1
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| EC 5
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| Abbott
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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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| C 7
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| Susan Tumbarello
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| Vol #:
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| 1
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| 2007N-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| C 5
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| American Society For Reproductive Medicine
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| Vol #:
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| 2
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| NCR 1
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| FDA
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| Vol #:
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| 2
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| 2007N-0382
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| Ramipril Capsules and 180-day generic drug exclusivity
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| C 8
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| FOLEY & LARDNER LLP
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| Vol #:
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| 1
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| 2007P-0062
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| Determine Whether a Previously Listed Drug Eloxatin (oxaliplatin for injection) Lyophilized Powder for Infusion, 50 and 100 mg Vials Has Been Voluntarily Withdrawn From Sale for Safety or Efficacy Rea
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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-0178
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| Take action to subject certain cardiac surgery devices to premarket notification (510(k) requirements
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| LET 1
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| Mark Raza
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| Vol #:
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| 1
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