| | | | | | | | | | |
|
| |
|
| Dockets Entered
On March 29, 2006
Table of Contents
|
|
|
|
|
|
|
|
| |
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1976N-0052N
|
| OTC Nasal Decongestants
|
|
|
|
|
| 1981N-0022
|
| OTC Weight Control Drug Products for Human Use
|
|
|
|
|
| 1998N-0046
|
| Comprehensive List of Current Guidance Documents at FDA
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
| 1998P-0724
|
| Prohibition of Cochineal Extract and Carmine Color Additives
|
|
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| 2004D-0343
|
| Hospital Bed System Dimensional Guidance to Reduce Entrapment
|
|
|
|
|
| 2004P-0451
|
| ANDA Suitability for Carbinoxamine Maleate 4 mg Chewable Tablets
|
|
|
|
|
| 2005D-0286
|
| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
|
|
|
|
|
| 2005FL-0434
|
| Food Allergen Labeling Notification (FALN): Extensively Hydrolyzed Casein
|
|
|
|
|
| 2005FL-0488
|
| Food Allergen Labeling Notification (FALN): Starter Growth Media, Soy
|
|
|
|
|
| 2005N-0285
|
| Current Good Manufacturing Practice Regulation and Investigational New Drugs
|
|
|
|
|
| 2005N-0374
|
| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
|
|
|
|
|
| 2005N-0395
|
| Agency Information Collection: Guidance on Formal Meetings with Sponsors and Applicants for PDUFA
|
|
|
|
|
| 2005N-0416
|
| Food Allergen Labeling Notification (FALN): Extensively Hydrolyzed Casein
|
|
|
|
|
| 2005N-0507
|
| Agency Emergency Processing Under OMB Review; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable
|
|
|
|
|
| 2005N-0508
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Healthcare Practitioners Regarding their Preferences for Public Health Notifications
|
|
|
|
|
| 2005N-0510
|
| Anti-Counterfeit Drug Initiative Workshop and Vendor Display
|
|
|
|
|
| 2005P-0400
|
| permission to Donna Ricks to continue using Palladone for severe chronic pain due to stage 4 metastic breast cancer
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| 2005P-0436
|
| ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.
|
|
|
|
|
| 2005Q-0297
|
| Qualified Health Claim (QHC): Green Tea and Reduced Risk of Cardiovascular Disease
|
|
|
|
|
| 2006D-0066
|
| Guidance for Industry and FDA Staff: Whole Grains Label Statements
|
|
|
|
|
| 2006FL-0017
|
| Food Allergen Labeling Notification for Purity Foods Vita Spelt
|
|
|
|
|
| 2006N-0106
|
| New Animal Drugs; Adamantane and Neuraminidase Inhibitor Anti-influenza Drugs; Extralabel Animal Drug Use; Order of Prohibition
|
|
|
|
|
| 2006N-0118
|
| Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Reagents for Detection of Specific Novel Influenza A Viruses
|
|
|
|
|
| 2006P-0140
|
| To withhold approval of any ANDA for a generic version of acitretin capsules
|
|
|
|
|
| 1976N-0052N
|
| OTC Nasal Decongestants
|
|
|
| EMC 139
|
| P. Whelan, MD, PhD
|
| Vol #:
|
| 77
|
|
|
|
|
| 1981N-0022
|
| OTC Weight Control Drug Products for Human Use
|
|
|
|
|
| EMC 60
|
| P. Whelan, MD, PhD
|
| Vol #:
|
| 93
|
|
| | | | | | | | |
|
|
|
| 1998N-0046
|
| Comprehensive List of Current Guidance Documents at FDA
|
|
|
|
|
| N 11
|
| FDA
|
| Vol #:
|
| 2
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
| C 7527
|
| B. Blitz
|
| Vol #:
|
| 319
|
|
|
|
|
| EMC 4395
|
| J. Harker
|
| Vol #:
|
| 320
|
|
|
|
|
| EMC 4396
|
| K. Fendrich
|
| Vol #:
|
| 320
|
|
|
|
|
| EMC 4397
|
| S. Munt
|
| Vol #:
|
| 320
|
|
|
|
|
| EMC 4398
|
| M. Lok
|
| Vol #:
|
| 320
|
|
|
|
|
| EMC 4399
|
| M. O'Rourke
|
| Vol #:
|
| 320
|
|
|
|
|
| 1998P-0724
|
| Prohibition of Cochineal Extract and Carmine Color Additives
|
|
|
|
|
| EMC 21
|
| M. Beaumont
|
| Vol #:
|
| 3
|
|
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
|
|
| EMC 636
|
| R. Mattingly
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC 637
|
| C. Camera
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC 638
|
| B. Worley
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC 639
|
| B. Hollowell
|
| Vol #:
|
| 24
|
|
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
|
|
| EMC 1315
|
| S. Reidy
|
| Vol #:
|
| 6
|
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
|
|
| EMC 620
|
| Mission Possible International
|
| Vol #:
|
| 9
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| EMC 1256
|
| No signature
|
| Vol #:
|
| 12
|
|
|
|
|
| EMC 1257
|
| V. Cunningham
|
| Vol #:
|
| 12
|
|
|
|
|
| EMC 1258
|
| P. Pinholster
|
| Vol #:
|
| 12
|
|
| |
|
| 2004D-0343
|
| Hospital Bed System Dimensional Guidance to Reduce Entrapment
|
|
|
|
|
| C 43
|
| Bed Safety Consulting, Inc.
|
| Vol #:
|
| 3
|
|
|
|
|
| 2004P-0451
|
| ANDA Suitability for Carbinoxamine Maleate 4 mg Chewable Tablets
|
|
|
|
|
| LET 1
|
| HFD-600 to NuTec Incorporated
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0286
|
| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
|
|
|
|
|
| C 11
|
| Japan Society of Pharmaceutical Machinery and Engineering (JSPME)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 3
|
| Biotechnology Industry Organization (BIO)
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2005FL-0434
|
| Food Allergen Labeling Notification (FALN): Extensively Hydrolyzed Casein
|
|
|
|
|
| ANS 1
|
| HF-21 to Ross Products Division, Abbott Laboratories
|
| Vol #:
|
| 3
|
|
|
|
|
| 2005FL-0488
|
| Food Allergen Labeling Notification (FALN): Starter Growth Media, Soy
|
|
|
|
|
| ANS 1
|
| HF-21 to F & A Dairy of California, Inc
|
| Vol #:
|
| 1
|
|
| |
|
| 2005N-0285
|
| Current Good Manufacturing Practice Regulation and Investigational New Drugs
|
|
|
|
|
| C 4
|
| FDA Ready Consulting
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0374
|
| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
|
|
|
|
|
| EMC 11
|
| W. Berko
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0395
|
| Agency Information Collection: Guidance on Formal Meetings with Sponsors and Applicants for PDUFA
|
|
|
|
|
| SS 1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0416
|
| Food Allergen Labeling Notification (FALN): Extensively Hydrolyzed Casein
|
|
|
|
|
| ANS 1
|
| HF-21 to Mead Johnson Nutritionals
|
| Vol #:
|
| 1
|
|
|
|
|
| LET 2
|
| HFS-004 to Mead Johnson Nutritionals
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0507
|
| Agency Emergency Processing Under OMB Review; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable
|
|
|
|
|
|
|
|
|
| SS 1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0508
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Healthcare Practitioners Regarding their Preferences for Public Health Notifications
|
|
|
|
|
| N 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0510
|
| Anti-Counterfeit Drug Initiative Workshop and Vendor Display
|
|
|
|
|
| C 9
|
| Sanofi Pasteur, Inc.
|
| Vol #:
|
| 3
|
|
|
|
|
| 2005P-0400
|
| permission to Donna Ricks to continue using Palladone for severe chronic pain due to stage 4 metastic breast cancer
|
|
|
|
|
| M 1
|
| FDA/CDER
|
| Vol #:
|
| 1
|
|
| |
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| EMC 526
|
| J. Johnson
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 527
|
| E. Busch, PhD
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 528
|
| F. Wilhelmi
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 529
|
| P. Williford
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 530
|
| D. Pruitt
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 531
|
| B. Geikie
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 532
|
| L. SMith
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 533
|
| C. Church
|
| Vol #:
|
| 76
|
|
| | | | | | | | |
|
| |
|
| EMC 608
|
| G. Russell
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 609
|
| B. Davis
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 610
|
| S. Morrow
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 611
|
| L. Woods
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 612
|
| N. Crist
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 613
|
| R. Mattingly
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 614
|
| J. Wagoner
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 615
|
| S. Vandegrift
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 616
|
| R. Schumacher
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 617
|
| C. Pritchard
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 618
|
| E. Scanlan
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 619
|
| S. Saikaly
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 620
|
| B. Wade
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 621
|
| B. Wade
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 622
|
| G. Molter
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 623
|
| G. Wiltse
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 624
|
| J. Wohlman
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 625
|
| S. Trivison
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 626
|
| M. Mizell
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 627
|
| D. Clark
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 628
|
| B. Lavigne
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 629
|
| D. Swanson
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 630
|
| J. Trowbridge
|
| Vol #:
|
| 76
|
|
|
|
|
| 2005P-0436
|
| ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.
|
|
|
|
|
| SUP 3
|
| Banner Pharmacaps Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005Q-0297
|
| Qualified Health Claim (QHC): Green Tea and Reduced Risk of Cardiovascular Disease
|
|
|
|
|
| LET 2
|
| AAC Consulting Group
|
| Vol #:
|
| 5
|
|
|
|
|
| 2006D-0066
|
| Guidance for Industry and FDA Staff: Whole Grains Label Statements
|
|
|
|
|
| C 2
|
| King Arthur Flour Company, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| C 3
|
| Roman Meal Company
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006FL-0017
|
| Food Allergen Labeling Notification for Purity Foods Vita Spelt
|
|
|
|
|
| ANS 1
|
| HF-21 to Purity Foods, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0106
|
| New Animal Drugs; Adamantane and Neuraminidase Inhibitor Anti-influenza Drugs; Extralabel Animal Drug Use; Order of Prohibition
|
|
|
|
|
| EMC 1
|
| C. Smith
|
| Vol #:
|
| 2
|
|
