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| Dockets Entered On November 24, 2006
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| Docket #
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| Title
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| 2005D-0481
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| Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Do
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| 2006D-0303
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| Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| 2006D-0451
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| Guidance for Industry, Food and Drug Administration Staff, Eye Care Professionals, and Consumers
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| 2006N-0453
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| Food Defense Workshop; Public Workshop
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| 2006P-0089
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| Stay approval of all supplements to biologics licenses issued to Genentech ( BLA# 103705 ) and Biogen ( BLA# 103737) for Rituxan ( Rituximab)
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| 2006P-0093
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| ECOAnimal Health seeks permission to file an ANADA for a generic equivalent of the innovator product Ivomec (ivermectin) injection for cattle and swine , 1% sterile solution NADA 128-409, Merial LTD.,
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| 2006P-0209
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| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| C 1397
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| J. Devine
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| Vol #:
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| 259
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| C 69
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| J. Devine
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| Vol #:
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| 5
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| 2005D-0481
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| Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Do
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| GDL 2
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| Guidance
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| 1
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| NAD 2
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| FDA
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| 1
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| C 4
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| GE Health Care
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| Vol #:
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| 3
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| 2006D-0303
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| Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
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| C 6
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| GE Healthcare
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| Vol #:
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| 1
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| C 7
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| Pfizer Global Research & Development
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| 1
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| C 11
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| BeneChill, Inc.
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| Vol #:
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| 3
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| C 122
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| M.A. Rupert
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| Vol #:
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| 9
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| 2006D-0451
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| Guidance for Industry, Food and Drug Administration Staff, Eye Care Professionals, and Consumers
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| GDL 1
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| Guidance
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| 1
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| NAD 1
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| FDA
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| Vol #:
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| 1
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| 2006N-0453
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| Food Defense Workshop; Public Workshop
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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-0089
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| Stay approval of all supplements to biologics licenses issued to Genentech ( BLA# 103705 ) and Biogen ( BLA# 103737) for Rituxan ( Rituximab)
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| PDN 1
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| FDA/CDER to Michael Bannester
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| Vol #:
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| 1
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| 2006P-0093
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| ECOAnimal Health seeks permission to file an ANADA for a generic equivalent of the innovator product Ivomec (ivermectin) injection for cattle and swine , 1% sterile solution NADA 128-409, Merial LTD.,
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| PDN 2
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| FDA/ORA to ECO Animal Health
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| 1
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| 2006P-0209
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| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
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| RC 2
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| Valeant
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| Vol #:
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| 1
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| C 1
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| C.R. Green
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| Vol #:
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| 1
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