| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On May 25, 2004
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1995N-0309
|
| CGMPs for the Production of Infant Formula
|
|
|
|
|
| 1995S-0158
|
| Community Disclosure of Institutional Review Boards
|
|
|
|
|
| 1997N-0484S
|
| Human Cellular and Tissue-Based Products
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
|
|
| 2000P-1322
|
| Food Labeling and Allergen Contamination Control
|
|
|
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
|
|
|
|
| 2003D-0538
|
| Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Notification Submissions 510(k): Effect on FDA Review Clock and Performance Assessment
|
|
|
|
|
| 2003H-0432
|
| Civil Money Penalty, Korangy Radiology Associates, PA
|
|
|
|
|
| 2003P-0574
|
| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
|
|
|
|
|
| 2003P-0576
|
| Warning Label for all Food Products Which Contain Gluten
|
|
|
|
|
| 2004N-0086
|
| Diabetes: Targeting Safe and Effective Prevention and Treatment; Public Meeting
|
|
|
|
|
| 2004P-0140
|
| Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
|
|
|
|
|
| 2004P-0247
|
| Escitalopram oxalate my be filed for ANDA capsuel dosage form
|
|
|
|
|
| 2004Q-0102
|
| Qualified Health Claim: Calcium and Kidney/urinary stones
|
|
|
|
|
| 1995N-0309
|
| CGMPs for the Production of Infant Formula
|
|
|
|
|
| WDL
1
|
| International Formula Council
|
| Vol #:
|
| 9
|
|
|
|
|
| 1995S-0158
|
| Community Disclosure of Institutional Review Boards
|
|
|
|
|
| SUP
25
Attachments
|
| University of Washington IDE#G980067
|
| Vol #:
|
| 19
|
|
|
|
|
| SUP
26
Attachment 1, Other
Attachments
|
| Northfield Laboratories Inc BB IND 10719
|
| Vol #:
|
| 26
|
|
|
|
|
| 1997N-0484S
|
| Human Cellular and Tissue-Based Products
|
|
|
|
|
| NFR
1
|
| FDA
|
| Vol #:
|
| 27
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| LET
13959
|
| Bios Biochemicals Corp.
|
| Vol #:
|
| 119
|
|
|
|
|
| LET
13960
|
| Now Foods
|
| Vol #:
|
| 119
|
|
|
|
|
| LET
13961
|
| Natural Organics, Inc.
|
| Vol #:
|
| 119
|
|
|
|
|
| LET
13962
|
| Source Naturals
|
| Vol #:
|
| 119
|
|
|
|
|
| LET
13963
|
| Source Naturals
|
| Vol #:
|
| 119
|
|
|
|
|
| LET
13964
|
| Biotech corporation
|
| Vol #:
|
| 119
|
|
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
|
|
| CR
4
|
| Bayer Corporation & Animal Health Institute
|
| Vol #:
|
| 389
|
|
|
|
|
| SUP
9
|
| Bayer Corporation & Animal Health Institute
|
| Vol #:
|
| 389
|
|
|
|
|
| 2000P-1322
|
| Food Labeling and Allergen Contamination Control
|
|
| | | | | | | | |
|
|
|
|
| C
546
|
| Stockbridge Family Medicine
|
| Vol #:
|
| 30
|
|
|
|
|
| MT
1
|
| HFS-24 and Stockbridge Family Medicine
|
| Vol #:
|
| 30
|
|
|
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
|
|
|
|
| NCR
4
|
| FDA
|
| Vol #:
|
| 28
|
|
|
|
|
| 2003D-0538
|
| Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Notification Submissions 510(k): Effect on FDA Review Clock and Performance Assessment
|
|
|
|
|
| GDL
1
|
| GUIDANCE
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003H-0432
|
| Civil Money Penalty, Korangy Radiology Associates, PA
|
|
|
|
|
| RMO
2
|
| GCF-1
|
| Vol #:
|
| 2
|
|
|
|
|
| 2003P-0574
|
| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0576
|
| Warning Label for all Food Products Which Contain Gluten
|
|
|
|
|
| MT
1
|
| HFS-24 and Stockbridge Family Medicine
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0086
|
| Diabetes: Targeting Safe and Effective Prevention and Treatment; Public Meeting
|
|
|
|
|
| EMC 1
|
| Consumer
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0140
|
| Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
|
|
|
|
|
| EMC
3
|
| King Pharmaceuticals, Inc
|
| Vol #:
|
| 2
|
|
|
|
|
| SUP
2
|
| Mutual Pharmaceutical Co., Inc
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004P-0247
|
| Escitalopram oxalate my be filed for ANDA capsuel dosage form
|
|
|
|
|
| ACK
1
|
| Alphapharm Pty Ltd of Glebe
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| Alphapharm Pty Ltd of Glebe
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004Q-0102
|
| Qualified Health Claim: Calcium and Kidney/urinary stones
|
|
|
|
|
| SUP
1
|
| Marine Bio USA Inc
|
| Vol #:
|
| 6
|
|
