| | | | | | | | | | |
|
Dockets Management
|
|
| Dockets Entered On
August 10, 2006
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1988N-0258
|
| Prescription Drug Marketing Act of 1987; Guideline
|
|
|
|
|
| 1992N-0297
|
| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
|
|
|
|
|
| 1997D-0318
|
| Revised Precautionary Measure to Reduce Transmission of CJD
|
|
|
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
|
|
|
|
| 2005D-0021
|
| International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| 2006A-0318
|
| Request for Advisory Opinion Concerning Orange Book Listing of Patents
|
|
|
|
|
| 2006P-0071
|
| 513 (e) Reclassification of Tissue Adhesive For Soft Tissue Approximation
|
|
|
|
|
| 2006P-0123
|
| Request that all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products
|
|
|
|
|
| 2006P-0151
|
| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
|
|
|
|
|
| 1988N-0258
|
| Prescription Drug Marketing Act of 1987; Guideline
|
|
|
|
|
| PDN 1
|
| FDA to Kleinfeld, Kaplan and Becker, LLP
|
| Vol #:
|
| 6
|
|
|
|
|
| 1992N-0297
|
| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
|
|
|
|
|
| PAV 2
|
| FDA to U.S. Small Business Administration
|
| Vol #:
|
| 10
|
|
|
|
|
| PDN 1
|
| FDA to Kleinfeld, Kaplan and Becker, LLP
|
| Vol #:
|
| 1
|
|
|
|
|
| 1997D-0318
|
| Revised Precautionary Measure to Reduce Transmission of CJD
|
|
|
|
|
| BKG 1
|
| Background Material
|
| Vol #:
|
| 5
|
|
|
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
|
|
|
|
| C 1389
|
| K. Michalak
|
| Vol #:
|
| 259
|
|
|
|
|
| 2005D-0021
|
| International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development
|
|
|
|
|
| EC 11
|
| Arizona resident
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| C 18016
|
| K. Hogan
|
| Vol #:
|
| 194
|
|
|
|
|
| 2006A-0318
|
| Request for Advisory Opinion Concerning Orange Book Listing of Patents
|
|
|
|
|
| ACK 1
|
| FDA/DDM to Ropes & Gray
|
| Vol #:
|
| 1
|
|
|
|
|
| AP 1
|
| Ropes & Gray
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0071
|
| 513 (e) Reclassification of Tissue Adhesive For Soft Tissue Approximation
|
|
|
|
|
| C 1
|
| Closure Medical Corporation (Closure)
|
| Vol #:
|
| 2
|
|
|
|
|
| 2006P-0123
|
| Request that all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products
|
|
|
|
|
| SUP 3
|
| Mylan Laboratories Inc.
|
| Vol #:
|
| 1
|
|
