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Dockets Management
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| Dockets Entered On May 19, 2006
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| Docket #
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| Title
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| 2003D-0379
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| Draft Guidance for Industry on Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition; Availability
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| 2005D-0112
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| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
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| 2005N-0065
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| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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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-0458
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| Refrain from approving ANDA 77-271 until the three-year period of market exclusivity for the product has expired.
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| 2005P-0464
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| Remove metered-dose inhalers (MDI) containing the single active moieties beclomethasone, fluticasone, and salmeterol, respectively, from the essential-use list of ozone-depleting substance
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| 2005Q-0298
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| Qualified Health Claim (QHC): 100% Whey Protein Hydrolyzed in Infant Formula and Reduced Risk of Allergy in Infants
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| 2006N-0051
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| Blood Vessels Recovered with Organs and Intended for Use in Organ Transplantation
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| 2006N-0133
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to-Consumer (DTC) Print Adver
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| 2006N-0181
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| Product Stability Data: Notice of Pilot Project
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| 2006P-0071
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| 513 (e) Reclassification of Tissue Adhesive For Soft Tissue Approximation
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| 2006P-0212
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| Lasik due to the use of research from experiments conducted on human beings without proper basis to believe it is in the patients best interests and improper patient informed consent
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| 2006P-0213
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| enforce the single-use requirement for all Microkeratomes and their components used by Lasik
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| 2003D-0379
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| Draft Guidance for Industry on Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition; Availability
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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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| 2005D-0112
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| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
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| C 6
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| ImClone Systems Inc. (ImClone)
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| 1
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| 2005N-0065
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| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
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| C 4
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| Gynuity Health Projects, Ipas, National Aboration Federation, National Women's Health Network, Rep
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| 1
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| C 9
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| No signature
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| Vol #:
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| 1
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| C 12
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| Columbia University
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| Vol #:
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| 7
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| LET 4
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| BGS Reclassification Opposition Group (BGS Group)
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| Vol #:
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| 7
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| SUP 2
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| RS Medical
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| Vol #:
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| 3
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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 9461
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| L. Anderson
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| Vol #:
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| 134
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| C 9462
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| D. Fagvin
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| Vol #:
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| 134
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| LET 1
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| FDA/CDER to Skadden, Arps, Slate, Meagher & Flom LLP
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| Vol #:
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| 1
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| 2005Q-0298
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| Qualified Health Claim (QHC): 100% Whey Protein Hydrolyzed in Infant Formula and Reduced Risk of Allergy in Infants
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| PDN 1
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| FDA/CFSA to Nestle USA
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| Vol #:
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| 8
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| 2006N-0051
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| Blood Vessels Recovered with Organs and Intended for Use in Organ Transplantation
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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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| NPR 1
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| FDA
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| Vol #:
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| 1
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| 2006N-0133
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to- Consumer (DTC) Print Adver
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| C 1
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| A. Kasower
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| Vol #:
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| 1
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| 2006N-0181
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| Product Stability Data: Notice of Pilot Project
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| LET 1
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| Cornerstone Regulatory
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| Vol #:
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| 1
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| 2006P-0071
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| 513 (e) Reclassification of Tissue Adhesive For Soft Tissue Approximation
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| AMD 1
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| Regulatory & Clinical Research Institute, Inc ( RCRI )
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| Vol #:
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| 1
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| 2006P-0212
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| Lasik due to the use of research from experiments conducted on human beings without proper basis to believe it is in the patients best interests and improper patient informed consent
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| ACK 1
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| HFA-305 to Michael Patterson
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| Vol #:
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| 1
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| 2006P-0213
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| enforce the single-use requirement for all Microkeratomes and their components used by Lasik
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| ACK 1
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| HFA-305 to Michael Patterson
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| Vol #:
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| 1
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