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| Dockets Entered
On December 21, 2005
Table of Contents
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| Docket #
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| Title
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| 1998D-0266
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| Section 121 Positron Emission Tomography (PET) FDAMA
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| 2000P-1491
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| Amend Definition & Standard of Identy for Parmesan Cheese
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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| 2004N-0439
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| Current Good Manufacturing Practice for Positron Emission Tomography Drugs
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| 2004Q-0180
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| Qualified Health Claim (QHC): Lutein and Eye Diseases
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| 2005D-0240
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| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| 2005D-0340
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| Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| 2005N-0364
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| Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting
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| 2005N-0410
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| Prescription Drug User Fee Act (PDUFA): Public Meeting
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| 2005N-0485
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| Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices)
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| 2005P-0305
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| Remove Dietary Supplements that Contain the Drug Pyridoxamine
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| 2005P-0323
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| Immediately remove Adderall and Adderall XR from the market for safety reasons
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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-0420
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| Establish therapeutic equivalence requirements for any generic or following-on drug product referencing Adderall XR MASP
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| 2005P-0495
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| Dietary supplement VI-28 TM clarifying, in writing, whether or not the dietary supplement , as detailed in the pre-market notification filed 18 August 2005
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| 2005P-0501
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| To revise the FDA's guidance document entitled labeling for combined oral contraeceptives so that the labels of combined oral contraceptives have warnings relating to the risk of thromboembolic disea
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| 2005P-0502
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| Reclassification petition for the digital mammography devices under section 513(e)
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| 2005V-0499
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| Laser Light Show regarding GCP-1,GCP-2
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| N 1
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| FDA
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| Vol #:
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| 142
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| NFR 2
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| FDA
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| Vol #:
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| 142
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| SUP 47
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| Northfield Laboratories Inc, BB IND #10,719
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| Vol #:
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| 50
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| 1998D-0266
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| Section 121 Positron Emission Tomography (PET) FDAMA
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| C 18
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| PET Manufacturing Consultant
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| 15
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| 2000P-1491
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| Amend Definition & Standard of Identy for Parmesan Cheese
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| C 1
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| Antigo Cheese Company
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| 1
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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| C 14
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| E Roth
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| Vol #:
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| 2
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| C 15
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| P Drumm
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| Vol #:
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| 2
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| C 16
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| Antigo Cheese Company
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| Vol #:
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| 2
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| C 17
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| Family Dairies USA
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| Vol #:
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| 2
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| 2004N-0439
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| Current Good Manufacturing Practice for Positron Emission Tomography Drugs
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| C 4
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| PET Manufacturing Consultant
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| Vol #:
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| 1
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| 2004Q-0180
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| Qualified Health Claim (QHC): Lutein and Eye Diseases
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| PDN
1
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| HFS-800 to AAC Consulting Group
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| Vol #:
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| 6
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| 2005D-0240
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| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
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| C 10
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| University of Buffalo School of Dental Medicine
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| Vol #:
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| 1
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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| C 7
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| University of Texas MD Anderson Cancer Center
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| Vol #:
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| 3
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| C 8
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| University of Iowa Hospitals & Clinics
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| Vol #:
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| 3
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| EXT 1
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| Blood and Tissue Center of Central Texas
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| Vol #:
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| 3
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| EXT 2
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| Blood and Tissue Center of Central Texas
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| Vol #:
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| 4
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| 2005D-0340
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| Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment
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| C 3
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| Connectics
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| Vol #:
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| 1
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| C 4
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| Medicis Pharmaceutical Company
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| Vol #:
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| 1
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| EC 2
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| Medicis Pharmaceutical
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| Vol #:
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| 1
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| EC 3
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| Medicis Pharmaceutical
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| Vol #:
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| 1
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| EC 4
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| Medicis Pharmaceutical
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| Vol #:
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| 1
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| EC 5
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| Medicis Pharmaceutical
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| Vol #:
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| 1
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| EC 403
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| Mrs. Lisa Bazler
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| Vol #:
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| 5
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| EC 404
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| Dr. Albert Galves
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| Vol #:
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| 5
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| EC 405
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| Mrs. Susan Reich
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| Vol #:
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| 5
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| EC 406
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| Dr. Albert Galves
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| Vol #:
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| 5
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| 2005N-0364
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| Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting
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| TS 1
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| Medical Device Manufacturers Association (MDMA)
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| Vol #:
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| 1
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| TS 2
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| Advanced Medical Technology (AdvaMed), Cordis Corporation
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| Vol #:
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| 1
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| TS 3
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| National Electrical Manufacturers Association
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| Vol #:
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| 1
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| TS 4
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| Advanced Medical Technology (AdvaMed)
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| Vol #:
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| 1
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| TS 5
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| National Electrical Manufacturers Association
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| Vol #:
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| 1
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| TS 6
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| Advanced Medical Technology Association (AdvaMed)
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| Vol #:
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| 1
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| TS 7
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| Association of Medical Device Reprocessors
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| Vol #:
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| 1
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| TS 8
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| Association of Medical Device Reprocessors
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| Vol #:
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| 1
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| TS 9
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| National Electrical Manufacturers Association
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| Vol #:
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| 1
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| TS 10
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| National Venture Capital Association (NVCA)
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| Vol #:
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| 1
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| TS 11
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| National Research Center for Women & Families
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| Vol #:
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| 1
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| 2005N-0410
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| Prescription Drug User Fee Act (PDUFA): Public Meeting
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| C 4
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| Pharmaceutical Research and Manufacturers of America
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| Vol #:
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| 1
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| 2005N-0485
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| Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices)
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| NM 1
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| FDA
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| Vol #:
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| 1
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| 2005P-0305
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| Remove Dietary Supplements that Contain the Drug Pyridoxamine
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| C 2
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| Jarrow Formulas Inc
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| Vol #:
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| 1
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| 2005P-0323
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| Immediately remove Adderall and Adderall XR from the market for safety reasons
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| EC 4
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| Mr. Dave 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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| EC 19
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| BHRT Patient
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| Vol #:
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| 1
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| EC 20
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| Mrs. Stacie Blewett
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| Vol #:
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| 1
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| EC 21
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| Mr. William Mixon
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| Vol #:
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| 1
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| EC 22
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| moses lake professional pharmacy
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| Vol #:
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| 1
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| EC 23
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| Dr. kenneth weld
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| Vol #:
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| 1
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| EC 24
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| Valley Pharmacy and Professional Compounding
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| Vol #:
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| 1
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| EC 25
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| Mrs. Susan Mackenzie
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| Vol #:
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| 1
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| EC 26
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| Mrs. Sandra Swert
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| Vol #:
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| 1
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| EC 27
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| Dr. Amy Stine
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| Vol #:
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| 1
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| 2005P-0420
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| Establish therapeutic equivalence requirements for any generic or following-on drug product referencing Adderall XR MASP
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| C 1
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| Barr Laboratories Inc
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| Vol #:
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| 2
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| 2005P-0495
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| Dietary supplement VI-28 TM clarifying, in writing, whether or not the dietary supplement , as detailed in the pre-market notification filed 18 August 2005
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| ACK 2
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| Number not used
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| Vol #:
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| 1
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| 2005P-0501
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| To revise the FDA's guidance document entitled labeling for combined oral contraeceptives so that the labels of combined oral contraceptives have warnings relating to the risk of thromboembolic disea
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| ACK 1
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| HFA-305 to Hyman, Phelps & McNamara, P.C
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| Vol #:
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| 1
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