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| Dockets Entered
On May 31, 2006
Table of Contents
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| Docket #
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| Title
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003P-0176
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| Follow-On Approval of Therapeutic Protein Products
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| 2004P-0171
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| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
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| 2004P-0231
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| Deny approval of NDA 21-426 for Ominitrop 5.8 mg somatropin [ rDNA origin ] for injection, lyophilized powder and diluent with preservative
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| 2004P-0359
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| Suitability Petition for (New Strength) Methacholine Chloride 1280 mg/vial
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| 2004P-0511
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| ANDA for Methacholine Chloride 1280 mg/vial
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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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| 2006D-0128
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| Guidance for Industry on Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions
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| 2006D-0150
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| Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and Food and Drug Administration: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Sp
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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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| 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-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-0124
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| Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
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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-0223
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| swith Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA because of
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| EMC 251
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| S. Marquet
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| Vol #:
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| 4
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 650
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| Calorie Control Council
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| Vol #:
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| 9
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| EMC 651
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| Mission Possible International
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| Vol #:
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| 9
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 1291
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| R. Rodegeb
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| Vol #:
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| 12
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| EMC 1292
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| S. Sarlls
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| Vol #:
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| 12
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| EMC 1293
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| M. Paulsen
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| Vol #:
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| 12
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| EMC 1294
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| M. Paulsen
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| Vol #:
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| 12
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| EMC 1295
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| P. Mortensen
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| Vol #:
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| 12
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| EMC 1296
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| M. Oakley
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| Vol #:
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| 12
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| 2003P-0176
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| Follow-On Approval of Therapeutic Protein Products
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| LET 1
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| FDA/CDER to Biotechnology Industry Organization (BIO)
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| Vol #:
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| 2
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| LET 1
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| FDA/CDER
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| Vol #:
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| 5
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| TR 2
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| FDA/DIA Scientific Workdhop on Follow-On Protein Pharmaceuticals (PLENARY SESSION)
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| 6
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| TR 3
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| FDA/DIA Scientific Workdhop on Follow-On Protein Pharmaceuticals (Breakout Session A)
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| 7
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| TR 4
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| FDA/DIA Scientific Workdhop on Follow-On Protein Pharmaceuticals (Breakout Session A)
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| Vol #:
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| 8
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| TR 5
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| FDA/DIA Scientific Workdhop on Follow-On Protein Pharmaceuticals (Breakout Session B)
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| Vol #:
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| 9
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| TR 6
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| FDA/DIA Scientific Workdhop on Follow-On Protein Pharmaceuticals (Breakout Session B)
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| Vol #:
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| 10
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| TR 7
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| FDA/DIA Scientific Workdhop on Follow-On Protein Pharmaceuticals (Breakout Session C)
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| Vol #:
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| 11
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| TR 8
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| FDA/DIA Scientific Workdhop on Follow-On Protein Pharmaceuticals (Breakout Session C)
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| Vol #:
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| 12
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| TR 9
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| FDA/DIA Scientific Workdhop on Follow-On Protein Pharmaceuticals (Breakout Session D)
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| Vol #:
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| 13
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| TR 10
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| FDA/DIA Scientific Workdhop on Follow-On Protein Pharmaceuticals (Breakout Session D)
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| Vol #:
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| 14
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| TR 11
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| FDA/DIA Scientific Workdhop on Follow-On Protein Pharmaceuticals (PLENARY SESSION)
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| Vol #:
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| 15
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| TR 12
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| FDA/DIA Scientific Workdhop on Follow-On Protein Pharmaceuticals (BREAKOUT SESSION E)
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| Vol #:
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| 16
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| TR 13
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| FDA/DIA Scientific Workdhop on Follow-On Protein Pharmaceuticals (BREAKOUT SESSION E)
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| Vol #:
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| 17
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| TR 14
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| FDA/DIA Scientific Workdhop on Follow-On Protein Pharmaceuticals (BREAKOUT SESSION F)
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| Vol #:
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| 18
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| TR 15
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| FDA/DIA Scientific Workdhop on Follow-On Protein Pharmaceuticals (BREAKOUT SESSION F)
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| Vol #:
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| 19
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| TR 16
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| FDA/DIA Scientific Workdhop on Follow-On Protein Pharmaceuticals (PLENARY SESSION)
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| Vol #:
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| 20
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| 2004P-0171
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| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
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| LET 2
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| FDA/CDER to Genentech, Inc.
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| Vol #:
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| 2
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| 2004P-0231
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| Deny approval of NDA 21-426 for Ominitrop 5.8 mg somatropin [ rDNA origin ] for injection, lyophilized powder and diluent with preservative
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| PDN 1
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| FDA/CDER to Morgan Lewis & Bocklus LLP
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| Vol #:
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| 1
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| 2004P-0359
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| Suitability Petition for (New Strength) Methacholine Chloride 1280 mg/vial
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2004P-0511
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| ANDA for Methacholine Chloride 1280 mg/vial
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| C 1
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| D. Lowe
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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 11433
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| I. F. Wegman
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| Vol #:
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| 147
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| C 11434
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| G. Tarantini
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| Vol #:
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| 147
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| C 11435
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| R. Macklin
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| Vol #:
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| 147
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| C 11436
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| B. K. Johl
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| Vol #:
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| 147
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| C 11437
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| D. L. Lowe
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| Vol #:
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| 147
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| C 11438
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| M. A. Oliver
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| Vol #:
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| 147
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| | | | | | | | |
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| Consumer (DTC) Print Adver
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| EMC 2
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| T. Brady
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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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| C 1
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| D. Lowe
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| Vol #:
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| 1
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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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| C 3
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0124
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| Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
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| SUP 1
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| ViroPharma, Incorporated (ViroPharma)
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| Vol #:
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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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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0223
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| swith Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA because of
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| ACK 1
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| HFA-305 to Wisconsin Department of Justice
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| Vol #:
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| 1
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