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| Dockets Entered
On June 13, 2006
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| Docket #
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| Title
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| 1998C-0790
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| synthetic iron oxide/mica to color food and titanium dioxide
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| 2000D-1318
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| Chronic Cutaneous Ulcer/Burn Wounds--Products for Treatment
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| 2005D-0019
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| Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Pri
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| 2005D-0288
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| International Conference on Harmonisation; Guidance on Q9 Quality Risk Management
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| 2005N-0364
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| Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting
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| 2005N-0437
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| Medical Gas Containers and Closures; Current Good Manufacturing
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2005P-0420
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| Establish therapeutic equivalence requirements for any generic or following-on drug product referencing Adderall XR MASP
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| 2006D-0079
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| Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables
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| 2006D-0088
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| Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
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| 2006D-0150
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| Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and Food and Drug Administration: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Sp
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| 2006N-0065
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| Emerging Clostridial Disease; Public Workshop
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| 2006N-0130
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Trans Fatty Acids in Nutrition Labeling
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| 2006N-0197
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| 2006P-0090
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| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
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| 2006P-0144
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| delalutin hydroxyprogesterone caproate) Injection was not withdrawn for safety or effectiveness reasons and therefore suibable for ANDA
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| 2006P-0177
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| ANDA Suitability for Methotrexate
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| 2006P-0205
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| Require Vitamin D be added to cereal-grain products
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| 2006P-0230
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| Abbrevation New Drug Application Suitability for Lidocaine Hydrochloride
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| 2006V-0244
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| Laser Light Show
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| 1998C-0790
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| synthetic iron oxide/mica to color food and titanium dioxide
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| BKG 1
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| BACKGROUND
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| 1
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| NFR 1
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| FDA
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| Vol #:
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| 1
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| 2000D-1318
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| Chronic Cutaneous Ulcer/Burn Wounds--Products for Treatment
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| GDL 2
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| GUIDANCE
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| Vol #:
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| 2
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| NAD 2
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| FDA
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| Vol #:
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| 2
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| 2005D-0019
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| Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Pri
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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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| 2005D-0288
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| International Conference on Harmonisation; Guidance on Q9 Quality Risk Management
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| GDL 2
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| GUIDANCE
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| Vol #:
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| 1
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| | | | | | | | |
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| NAD 2
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| FDA
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| Vol #:
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| 1
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| LET 12
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| Bristol-Myers Squibb Company (BMS)
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| Vol #:
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| 2
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| 2005N-0364
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| Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting
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| LST 2
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| Agenda for May 22, 2006 Stakeholder Meeting
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| 3
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| TS 14
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| CDRH: MDFUMA Performance Update
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| 3
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| TS 15
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| National Venture Capital Association
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| Vol #:
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| 3
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| 2005N-0437
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| Medical Gas Containers and Closures; Current Good Manufacturing
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| C 2
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| American Association for Respiratory Care (AARC)
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| Vol #:
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| 1
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| EC 5
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| CEE KAY SUPPLY
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| Vol #:
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| 1
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| EC 6
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| Pulmonox Gas Corp.
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| Vol #:
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| 1
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| C 12484
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| D. R.McNab
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| Vol #:
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| 151
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| C 12485
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| S.Selus
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| Vol #:
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| 151
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| C 12486
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| M. Gibson
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| Vol #:
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| 151
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| C 12487
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| C. Lebane
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| Vol #:
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| 151
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| C 12488
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| S. Matherne
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| Vol #:
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| 151
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| C 12489
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| M. P. Fansy
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| Vol #:
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| 151
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| C 12490
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| M. Curole
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| Vol #:
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| 151
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| C 12491
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| D. Wagner
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| Vol #:
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| 151
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| C 12492
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| A. C. Vinson
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| Vol #:
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| 151
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| C 12493
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| B. Hazel
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| Vol #:
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| 151
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| C 12494
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| B. Ivesten
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| Vol #:
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| 151
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| C 12495
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| M. C. Garces
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| Vol #:
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| 151
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| C 12496
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| W. L. Balzer
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| Vol #:
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| 151
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| C 12497
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| M. Marquiz
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| Vol #:
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| 151
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| C 12498
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| M. Carpenter
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| Vol #:
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| 151
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| C 12499
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| L. Kravss
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| Vol #:
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| 151
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| C 12500
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| D. M. Johnsen
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| Vol #:
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| 151
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| C 12501
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| K. Mrljak
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| Vol #:
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| 151
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| C 12502
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| S. Peyton
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| Vol #:
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| 151
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| C 12503
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| M. Cameron
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| Vol #:
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| 151
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| C 12504
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| A. McCarthy
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| Vol #:
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| 151
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| C 12505
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| C. Aquars
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| Vol #:
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| 151
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| 2005P-0420
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| Establish therapeutic equivalence requirements for any generic or following-on drug product referencing Adderall XR MASP
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| RC 1
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| Shire Pharmaceuticals Group
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| Vol #:
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| 2
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| 2006D-0079
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| Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables
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| EC 3
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| Produce Marketing Association
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| Vol #:
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| 1
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| |
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| 2006D-0088
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| Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
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| EC 4
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| MedImmune
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| Vol #:
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| 1
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| EC 5
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| GlaxoSmithKline
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| Vol #:
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| 1
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| EC 6
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| Infectious Diseases Society of America
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| Vol #:
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| 1
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| EC 7
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| Sanofi Pasteur
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| Vol #:
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| 1
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| 2006D-0150
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| Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and Food and Drug Administration: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Sp
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| EC 3
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| Gateway Community College
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| Vol #:
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| 1
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| EC 4
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| LifeEthics.org
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| Vol #:
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| 1
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| 2006N-0065
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| Emerging Clostridial Disease; Public Workshop
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| EC 1
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| Planned Parenthood Federation of America
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| Vol #:
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| 2
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| 2006N-0130
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Trans Fatty Acids in Nutrition Labeling
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| EC 1
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| Miss. Angela Williams
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| Vol #:
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| 1
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| 2006N-0197
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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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-0090
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| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
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| EC 10
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| Mac's Medicine Mart, Inc.
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| Vol #:
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| 1
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| 2006P-0144
|
| delalutin hydroxyprogesterone caproate) Injection was not withdrawn for safety or effectiveness reasons and therefore suibable for ANDA
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| EC 2
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| Mac's Medicine Mart, Inc.
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| Vol #:
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| 1
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| 2006P-0177
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| ANDA Suitability for Methotrexate
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2006P-0205
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| Require Vitamin D be added to cereal-grain products
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| EC 1
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| Mrs. T Briola
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| Vol #:
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| 2
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| 2006P-0230
|
| Abbrevation New Drug Application Suitability for Lidocaine Hydrochloride
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| CR 1
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| FDA/ DDM to Odan Laboratories, Inc.
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| Vol #:
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| 1
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