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| Dockets Entered
On August 28, 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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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
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| 1998D-0077
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| Treatment of osteoarthritis/drugs, devices and biological pt
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| 1998D-0307
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| Exports/Imports under FDA export reform/enhancement Act 1996
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutrition
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| 1999D-1878
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| Good Manufacturing Practice for Blood and Blood Components:
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| 1999N-2337
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| GMP for Blood & Blood Components;Increased Risk of Transmiti
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| 2001D-0286
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| In Vitro HIV Drug Resistance Genotype Assays [510(k)s]
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| 2002D-0081
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| Hepatitis B Surface Antigen (HBSAG) Assays to Test Blood
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| 2004D-0524
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| Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| 2004P-0326
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| ANDA for Adenosine Injection, USP 3 mg/mL with 6 mL and 10 mL fill volumes
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| 2006D-0083
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| Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines
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| 2006F-0059
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| Safe Use of Polydextrose as a Bulking Agent, Formulation Aid, Humectant and Texturizer in All Foods, except Meat and Poultry (FAP 6A4763)
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| 2006N-0104
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
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| 2006N-0105
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Environmental Impact Considerations Part 25 (21 CFR Part 25)
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| 2006P-0145
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| ANDA suitability for Gemcitabine
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| 2006P-0272
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| ANDA Suitability for 0.9% Sodium Chloride Injection
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| 2006P-0273
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| ANDA for Water for Injection, USP, in 3-, 5-, 15-, and 30-mL volumes
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| 2006P-0302
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| Permit the filing of an ANDA Suitability for Sodium Chloride Injection
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| 2006P-0533
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| ANDA Suitability for Sterile Vancomycin Hydrochloride USP, 750 mg
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| 2006P-0534
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| ANDA for Sterile Vancomycin Hydrochloride USP, 750 mg
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| 2007D-0137
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis
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| 2007D-0206
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| Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices
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| 2007N-0064
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| Electronic Case Report Form Submission; Notice of Pilot Project
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| 2007N-0324
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| Withdrawal of Approval of a New Animal Drug Application; Bacitracin Zinc
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| 2007P-0070
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| Make fluoride a prescription drug for use in tooth application, tooth paste, and in bottled water
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| 2007P-0297
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| Request to reconsider the failure to approve Provenge
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| 2007P-0322
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| Approval of Generic Versions of Pioglitazone Hydrochloride with Less than Complete Labeling
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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-0334
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| Prohibit the use of low molecular weight heparin in patients with acute or chronic renal failure and in elderly subjects more than 65 years of age
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| 1978N-0038
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| Sunscreen Drug Products
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| EC 14
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| Mrs. pam roach
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| Vol #:
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| 155
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| EC 1902
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| Ms. Shelby Platt
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| Vol #:
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| 160
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| EC 1903
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| Ms. Gillianne Beyer
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| Vol #:
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| 160
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| EC 1904
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| Ms. Mary Scavarda
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| Vol #:
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| 160
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| EC 1905
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| Ms. Caroline Williams
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| Vol #:
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| 160
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| EC 1906
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| Ms. Juliet Farrell
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| Vol #:
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| 160
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| EC 1907
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| Mrs. Julie DeCooman
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| Vol #:
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| 160
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| EC 1908
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| Green Careers
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| Vol #:
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| 160
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| EC 1909
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| N/A
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| Vol #:
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| 160
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| EC 1910
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| Mrs. Ariana Head
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| Vol #:
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| 160
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| EC 1911
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| Ms. Evelyn Stenseth
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| Vol #:
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| 160
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| EC 1912
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| Mr. Brent Mottley
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| Vol #:
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| 160
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| EC 1913
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| Ms. Elizabeth BIgley
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| Vol #:
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| 160
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| EC 1914
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| Ms. Jennifer Downing
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| Vol #:
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| 160
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| EC 1915
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| Mrs. Mary Hardy
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| Vol #:
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| 160
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| EC 1916
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| Mrs. Geri MADDEN
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| Vol #:
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| 160
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| EC 1917
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| Ms. Christina Kucsera
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| Vol #:
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| 160
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding
Dietary Supplements
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| C 276
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| Unknown
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| Vol #:
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| 54
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| 1998D-0077
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| Treatment of osteoarthritis/drugs,
devices and biological pt
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| EC 1
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| Osteoarthritis Reseach Society
International (OARS
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| Vol #:
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| 1
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| 1998D-0307
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| Exports/Imports under FDA export
reform/enhancement Act 1996
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| EC 1
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| Mr. Rick Swindell
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| Vol #:
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| 1
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| EC 2
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| Ms. Heather Richards
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| Vol #:
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| 1
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| EC 3
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| Mr. Adam Fogarty
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| Vol #:
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| 1
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| 1998N-0359
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| Program priorities/Center for
Food Safety & Applied Nutrition
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| EC 407
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| International Food Additives Council
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| Vol #:
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| 1
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| EC 408
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| Calorie Control Council
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| Vol #:
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| 1
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| 1999D-1878
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| Good Manufacturing Practice
for Blood and Blood Components:
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| REF 1
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| FDA
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| Vol #:
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| 1
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| 1999N-2337
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| GMP for Blood & Blood Components;Increased
Risk of Transmiti
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| REF 2
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| Diane Sullivan
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| Vol #:
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| 4
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| 2001D-0286
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| In Vitro HIV Drug Resistance
Genotype Assays [510(k)s]
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| EC 1
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| Mr. Adam Fogarty
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| Vol #:
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| 1
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| 2002D-0081
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| Hepatitis B Surface Antigen (HBSAG) Assays to Test Blood
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| EC 2
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| Mr. Adam Fogarty
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| Vol #:
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| 1
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| 2004D-0524
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| Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information
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| EC 6
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| Mr. Adam Fogarty
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| Vol #:
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| 1
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| EC 30
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| Miss. Chris Ann Rocha
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| Vol #:
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| 1
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| EC 31
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| God's kingdom
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| Vol #:
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| 1
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| 2004P-0326
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| ANDA for Adenosine Injection, USP 3 mg/mL with 6 mL and 10 mL fill volumes
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| PDN 1
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| Gary J. Buehler
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| Vol #:
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| 1
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| EC 37
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| Mr. David Harris
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| Vol #:
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| 1
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| 2006D-0083
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| Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines
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| EC 3
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| Why?
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| Vol #:
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| 1
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| 2006F-0059
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| Safe Use of Polydextrose as a Bulking Agent, Formulation Aid, Humectant and Texturizer in All Foods, except Meat and Poultry (FAP 6A4763)
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| EC 1
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| Mrs. Debra Whetzel
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| Vol #:
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| 1
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| 2006N-0104
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
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| EC 8
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| Mr. Patrick M. Pockat
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| Vol #:
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| 1
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| EC 9
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| Ms. Christina Mailhot
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| Vol #:
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| 1
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| EC 10
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| Mr. Adam Fogarty
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| Vol #:
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| 1
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| 2006N-0105
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Environmental Impact Considerations Part 25 (21 CFR Part 25)
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| EC 1
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| Mr. Adam Fogarty
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| Vol #:
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| 1
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| C 1766
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| A Harmen
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| Vol #:
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| 18
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| C 1767
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| M Miles Sr
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| Vol #:
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| 18
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| C 1768
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| E. Howe
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| Vol #:
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| 18
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| C 1769
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| L Hoover
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| Vol #:
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| 18
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| C 1770
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| C Jones
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| Vol #:
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| 18
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| C 1771
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| E Jones
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| Vol #:
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| 18
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| C 1772
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| M Hargrave
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| Vol #:
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| 18
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| C 1810
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| P Horter-Moore
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| Vol #:
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| 18
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| C 1811
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| J Mulrooney
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| Vol #:
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| 18
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| C 1812
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| G Norten Jr
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| Vol #:
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| 18
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| 2006P-0145
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| ANDA suitability for Gemcitabine
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| PAV 1
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| Gary J. Buehler
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| Vol #:
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| 1
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| 2006P-0272
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| ANDA Suitability for 0.9% Sodium Chloride Injection
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| PAV 1
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| Gary J. Buehler
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| Vol #:
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| 1
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| 2006P-0273
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| ANDA for Water for Injection, USP, in 3-, 5-, 15-, and 30-mL volumes
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| PAV 1
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| Gary J. Buehler
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| Vol #:
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| 1
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| 2006P-0302
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| Permit the filing of an ANDA Suitability for Sodium Chloride Injection
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| PAV 1
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| Gary J. Buehler
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| Vol #:
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| 1
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| 2006P-0533
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| ANDA Suitability for Sterile Vancomycin Hydrochloride USP, 750 mg
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| PAV 1
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| Gary J. Buehler
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| Vol #:
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| 1
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| 2006P-0534
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| ANDA for Sterile Vancomycin Hydrochloride USP, 750 mg
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| PAV 1
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| Gary J. Buehler
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| Vol #:
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| 1
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| 2007D-0137
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis
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| EC 1
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| Mrs. Debra Whetzel
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| Vol #:
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| 1
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| 2007D-0206
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| Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices
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| EC 1
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| Miss. erika bradshaw
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| Vol #:
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| 1
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| EC 2
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| Mr. Joshua Shidler
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| Vol #:
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| 1
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| 2007N-0064
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| Electronic Case Report Form Submission; Notice of Pilot Project
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| EC 2
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| Genzyme Corp.
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| Vol #:
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| 1
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| 2007N-0324
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| Withdrawal of Approval of a New Animal Drug Application; Bacitracin Zinc
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| NWL 1
|
| FDA
|
| Vol #:
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| 1
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| 2007P-0070
|
| Make fluoride a prescription drug for use in tooth application, tooth paste, and in bottled water
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| LET 1
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| Jane A. Axelrad
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| Vol #:
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| 1
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| EC 51
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| Mrs. Cherylyn Douglas
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| Vol #:
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| 1
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| 2007P-0297
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| Request to reconsider the failure to approve Provenge
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| C 1
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| Donald D. Yaw
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| Vol #:
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| 1
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