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Dockets Management
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| Dockets Entered On
August 10, 2006
Table of Contents
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| Docket #
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| Title
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| 1997D-0318
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| Revised Precautionary Measure to Reduce Transmission of CJD
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2005D-0021
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| International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development
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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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| 2006A-0318
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| Request for Advisory Opinion Concerning Orange Book Listing of Patents
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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-0123
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| Request that all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| PDN 1
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| FDA to Kleinfeld, Kaplan and Becker, LLP
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| Vol #:
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| 6
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| PAV 2
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| FDA to U.S. Small Business Administration
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| Vol #:
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| 10
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| PDN 1
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| FDA to Kleinfeld, Kaplan and Becker, LLP
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| Vol #:
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| 1
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| 1997D-0318
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| Revised Precautionary Measure to Reduce Transmission of CJD
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| BKG 1
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| Background Material
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| Vol #:
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| 5
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| C 1389
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| K. Michalak
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| Vol #:
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| 259
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| 2005D-0021
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| International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development
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| EC 11
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| Arizona resident
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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 18016
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| K. Hogan
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| Vol #:
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| 194
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| 2006A-0318
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| Request for Advisory Opinion Concerning Orange Book Listing of Patents
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| ACK 1
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| FDA/DDM to Ropes & Gray
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| Vol #:
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| 1
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| AP 1
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| Ropes & Gray
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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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| C 1
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| Closure Medical Corporation (Closure)
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| Vol #:
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| 2
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| 2006P-0123
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| Request that all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products
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| SUP 3
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| Mylan Laboratories Inc.
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| Vol #:
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| 1
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