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| Dockets Entered
On December 19, 2005
Table of Contents
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| Docket #
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| Title
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| 1998D-0266
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| Section 121 Positron Emission Tomography (PET) FDAMA
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| 2000P-1378
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| Cosmetic Products Containing Alpha Hydroxy Acids
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| 2000P-1491
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| Amend Definition & Standard of Identy for Parmesan Cheese
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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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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| 2005D-0219
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| Guidance for Industry: General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals
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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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| 2005M-0492
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| P030054/S010 - Epic and Atlas + HF CRT-D Systems
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| 2005N-0329
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| Designation of New Animal Drugs for Minor Uses or Minor Species
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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-0374
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| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
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| 2005N-0410
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| Prescription Drug User Fee Act (PDUFA): Public Meeting
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| 2005N-0479
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| International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol); Gamma-Hydroxybutyric Acid; Ketamine;
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| 2005P-0213
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| To change the classification of EEG electrodes currently classified as class II and requiring 510K approvals\
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| 2005P-0305
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| Remove Dietary Supplements that Contain the Drug Pyridoxamine
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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-0423
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| Immediately add a black box warning regarding the risks of drug-induced blindness for the three phosphodiesterase 5 inhibitors that are prescribed for the treatment of erectile dysfuntion
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| 2005P-0430
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| Requests that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act.
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| 2005P-0441
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| Reservoir Systems for Transdermal Delivery
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| 1998D-0266
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| Section 121 Positron Emission Tomography (PET) FDAMA
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| C
16
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| U S Pharmcopeia
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| Vol #:
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| 15
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| C
17
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| Society of Nuclear Medicine
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| Vol #:
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| 15
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| EC
4
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| Hyman, Phelps
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| Vol #:
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| 15
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| EC
5
Attachment
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| Society of Nuclear Medicine
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| Vol #:
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| 15
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| 2000P-1378
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| Cosmetic Products Containing Alpha Hydroxy Acids
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| EC 4
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| Mr. Eduardo Forero
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| Vol #:
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| 1
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| 2000P-1491
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| Amend Definition & Standard of Identy for Parmesan Cheese
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| EC
12
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| Mr. Ron Hovanec
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| Vol #:
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| 1
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| EC
13
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| Mr. Marlin Bullard
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| Vol #:
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| 1
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| EC
14
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| Mr. John Gulya
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| Vol #:
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| 1
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| EC
15
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| Mrs. Sheila Rowlison
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| Vol #:
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| 1
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| EC
5
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| Society of Nuclear Medicine
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| Vol #:
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| 1
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| 2005D-0219
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| Guidance for Industry: General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals
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| EC
5
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| PETA
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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
6
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| BloodSource
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| Vol #:
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| 3
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| 2005M-0492
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| P030054/S010 - Epic and Atlas + HF CRT-D Systems
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| AAV
1
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| St Jude Medical CRMD
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| Vol #:
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| 1
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| 2005N-0329
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| Designation of New Animal Drugs for Minor Uses or Minor Species
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| C
4
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| Land O Lakes Feed
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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
398
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| Mr. Michael Mauerer
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| Vol #:
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| 5
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| EC
399
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| Mrs. Marianne Rucker
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| Vol #:
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| 5
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| EC
400
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| Mrs. Antje Weinberger-Harrison
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| Vol #:
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| 5
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| EC
401
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| Ms. Dolly Angelette
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| Vol #:
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| 5
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| EC
402
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| Mrs. Melissa Bittner
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| Vol #:
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| 5
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| 2005N-0374
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| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
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| EC
1
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| University of South Alabama
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| Vol #:
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| 1
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| EC
2
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| Hershey Medical Center
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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
2
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| Plasma Protein Therapeutics Association
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| Vol #:
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| 1
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| C
3
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| Academy of Managed Care Pharmacy
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| Vol #:
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| 1
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| EC
9
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| National Consumers League
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| Vol #:
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| 1
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| EC
10
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| Washington Legal Foundation
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| Vol #:
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| 1
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| C
5
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| Fleminger Inc
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| Vol #:
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| 2
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| EC
2
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| Mr. Lewis Jacobs
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| Vol #:
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| 1
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| EC
3
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| American Medical Association
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| Vol #:
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| 1
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| 2005N-0479
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| International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol); Gamma- Hydroxybutyric Acid; Ketamine;
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| EC
1
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| Ms. Amy Cadotte
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| Vol #:
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| 1
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| EC
2
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| Mr. terry jacobs
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| Vol #:
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| 1
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| EC
3
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| Ms. Melissa Osterhoudt
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| Vol #:
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| 1
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| EC
4
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| Mr. Rene Carlos Guevara
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| Vol #:
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| 1
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| EC
5
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| Mr. Gregory A. H. Webber
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| Vol #:
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| 1
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| EC
6
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| 'Ray of Light Cannabis Chrisitan Ministry '
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| Vol #:
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| 1
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| 2005P-0213
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| To change the classification of EEG electrodes currently classified as class II and requiring 510K approvals\
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| ACK
2
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| HFA-305 to Scientific Laboratory Products
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| Vol #:
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| 1
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| CCP
1
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| Scientific Laboratory Products
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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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| EC
1
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| Mr. Warren Cochrane
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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
11
Attachment
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| American College of Obstetrician & Gynecologists
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| Vol #:
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| 1
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| EC
5
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| Health First ! Pharmacy
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| Vol #:
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| 1
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| EC
6
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| Village Pharmacy
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| Vol #:
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| 1
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| EC
7
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| Community Drug Compounding Center
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| Vol #:
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| 1
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| EC
8
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| Mrs. Charlotte DeVille
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| Vol #:
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| 1
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| EC
9
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| The Medicine Shoppe
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| Vol #:
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| 1
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| EC
10
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| Kirkpatrick's Pharmacy
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| Vol #:
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| 1
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| EC
11
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| Mr. Kirsten Ward
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| Vol #:
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| 1
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| EC
12
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| Medicine Shoppe Pharmacy
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| Vol #:
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| 1
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| EC
13
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| MEDICINE SHOPPE
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| Vol #:
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| 1
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| EC
14
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| Ms. vicki hedtke
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| Vol #:
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| 1
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| EC
15
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| Dr. Stacey Burns
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| Vol #:
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| 1
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| EC
16
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| Family Pharmacy
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| Vol #:
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| 1
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| EC
17
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| Mrs. Cynthia Wilfong
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| Vol #:
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| 1
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| 2005P-0423
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| Immediately add a black box warning regarding the risks of drug-induced blindness for the three phosphodiesterase 5 inhibitors that are prescribed for the treatment of erectile dysfuntion
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| EC
3
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| Ms. Irene Ferraiuolo
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| Vol #:
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| 1
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| 2005P-0430
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| Requests that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act.
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| EC
1
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| Mr. David Bulbow
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| Vol #:
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| 1
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| 2005P-0441
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| Reservoir Systems for Transdermal Delivery
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| EC
1
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| Mrs. Sheila Sorensen
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| Vol #:
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| 1
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