| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On September 20, 2005
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1998D-0266
|
| Section 121 Positron Emission Tomography (PET) FDAMA
|
|
|
|
|
| 2002D-0018
|
| Race and Ethnicity Data in Clinical Trials for FDA
|
|
|
|
|
| 2004N-0439
|
| Current Good Manufacturing Practice for Positron Emission Tomography Drugs
|
|
|
|
|
| 2005D-0195
|
| Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9
|
|
|
|
|
| 2005D-0337
|
| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque
|
|
|
|
|
| 2005D-0340
|
| Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment
|
|
|
|
|
| 2005N-0137
|
| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
|
|
|
|
|
| 2005N-0218
|
| FDA Vision 2006: A Conversation with the American Public
|
|
|
|
|
| 2005N-0231
|
| Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
|
|
|
|
|
| 2005N-0262
|
| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
|
|
|
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
|
|
|
|
|
| 2005N-0338
|
| Medical Devices; Dental Devices; Classification of Oral Rinse to Reduce the Adhesion of Dental Plaque
|
|
|
|
|
| 2005N-0345
|
| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
|
|
|
|
|
| 2005P-0383
|
| refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
|
|
|
|
|
| 2005P-0384
|
| Deficient Peripheral Metabolism of Thyroxine to Triiodothyronine
|
|
|
|
|
| 1998D-0266
|
| Section 121 Positron Emission Tomography (PET) FDAMA
|
|
|
|
|
| GDL
2
|
| Background Material
|
| Vol #:
|
| 15
|
|
|
|
|
| NAD
2
|
| FDA
|
| Vol #:
|
| 15
|
|
|
|
|
| 2002D-0018
|
| Race and Ethnicity Data in Clinical Trials for FDA
|
|
|
|
|
| GDL
2
|
| Guidance
|
| Vol #:
|
| 2
|
|
|
|
|
| NAD
2
|
| FDA
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004N-0439
|
| Current Good Manufacturing Practice for Positron Emission Tomography Drugs
|
|
|
|
|
| NPR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0195
|
| Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9
|
|
|
|
|
| EC
4
|
| DR Systems, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0337
|
| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque
|
|
|
| BKG 1
|
| HFZ-400
|
| Vol #:
|
| 1
|
|
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0340
|
| Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment
|
|
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2005N-0137
|
| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
|
|
|
|
|
| EC 27
|
| Ms. Patricia Marseglia
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 28
|
| Mrs. Marion Hammond
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 29
|
| Mrs. Marlyn Kenney
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 30
|
| N/A
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 31
|
| Mrs. Peggy Melton
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 32
|
| Ms. Sherry Conaway
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 33
|
| Mrs. Lori Skalitzky
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 34
|
| Mr. James Jackson
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 35
|
| Mrs. Lesley Clark
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 36
|
| Mrs. Linda Donaldson
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 37
|
| Ms. Amy Manning
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 38
|
| Ms. Carlene Ruesenberg
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 39
|
| Mrs. Dorothy Britt
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 40
|
| Mrs. Carollene Cagle
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 41
|
| Mrs. Judith Walker
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 42
|
| Ms. Cathy Smith
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 43
|
| Mrs. Sandra Bill
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 44
|
| Ms. C Schneider
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 45
|
| Mrs. Mary Ellen Gordon
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 46
|
| Mr. Robert Schweitzer
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 47
|
| Mrs. Darleen Souder
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0218
|
| FDA Vision 2006: A Conversation with the American Public
|
|
|
|
|
| EC
2
|
| American College of Neuropsychopharmacology
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0231
|
| Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
|
|
|
|
|
|
|
|
|
| C
4
|
| Grocery Manufacturers Association (GMA)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0262
|
| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
|
|
|
|
|
| NEC
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
|
|
|
|
|
| EC
1005
|
| Mrs. Jayne Zook
|
| Vol #:
|
| 18
|
|
|
|
|
| EC
1006
|
| Ms. Carolyn Dunaway
|
| Vol #:
|
| 18
|
|
|
|
|
| EC
1007
|
| Ms. Carol Mangano
|
| Vol #:
|
| 18
|
|
|
|
|
| EC
1008
|
| Ms. Amber Hicks
|
| Vol #:
|
| 18
|
|
