| | | | | | | | | | |
|
| |
|
| Dockets Entered
On November 7, 2003
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 2000D-1598
|
| Voluntary Labeling for Bioengineered Foods
|
|
|
|
|
| 2002H-0443
|
| Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care
|
|
|
|
|
| 2003D-0221
|
| Class II Special Controls Guidance Document: Endotoxin Activity Assay
|
|
|
|
|
| 2003D-0382
|
| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
|
|
|
|
|
| 2003D-0476
|
| Guidance for Industry on Product Recalls, Including Removals and Corrections; Availability
|
|
|
|
|
| 2003N-0302
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Certain Biologics Labeling
|
|
|
|
|
| 2003N-0338
|
| Obesity
|
|
|
|
|
| 2003N-0483
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Food Labeling Regulations
|
|
|
|
|
| 2003P-0387
|
| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
|
|
| |
|
| 2000D-1598
|
| Voluntary Labeling for Bioengineered Foods
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 580
|
|
|
|
|
| 2002H-0443
|
| Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care
|
|
|
|
|
| CS
19
|
| HFA-305
|
| Vol #:
|
| 1
|
|
|
|
|
| SET
2
|
| HF-3, Administrative Law Judge
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0221
|
| Class II Special Controls Guidance Document: Endotoxin Activity Assay
|
|
|
|
|
| GDL
1
|
| GUIDANCE
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| NFR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0382
|
| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
|
|
|
|
|
| C
21
|
| Vectech Pharmaceutical Consultants (VPC)
|
| Vol #:
|
| 2
|
|
|
|
|
| C
22
|
| Aventis Behring, LLC
|
| Vol #:
|
| 2
|
|
|
|
|
| C
23
|
| Organon, Inc.
|
| Vol #:
|
| 2
|
|
|
|
|
| C
24
|
| Aventis Pharmaceuticals, Inc.
|
| Vol #:
|
| 2
|
|
|
|
|
| C
25
|
| Vectech Pharmaceutical Consultants, Inc. (VPC)
|
| Vol #:
|
| 2
|
|
|
|
|
| C
26
|
| Wyeth Pharmaceuticals (Wyeth)
|
| Vol #:
|
| 2
|
|
|
|
|
| C
27
|
| Genentech, Inc.
|
| Vol #:
|
| 3
|
|
|
|
|
| C
28
|
| Aventis Pasteur, Inc.
|
| Vol #:
|
| 3
|
|
|
|
|
| C
29
|
| Eli Lilly and Company (Lilly)
|
| Vol #:
|
| 3
|
|
|
|
|
| 2003D-0476
|
| Guidance for Industry on Product Recalls, Including Removals and Corrections; Availability
|
|
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0302
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Certain Biologics Labeling
|
|
| | | | | | | | |
|
| |
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0338
|
| Obesity
|
|
|
|
|
| TR 2
|
| Transcript of the October 23, 2003 Meeting
|
| Vol #:
|
| 7
|
|
|
|
|
| TS
9
Attachments
1-7
|
| Shape Up America
|
| Vol #:
|
| 5
|
|
|
|
|
| TS
10
Powerpoint
|
| Center for Consumer Freedom
|
| Vol #:
|
| 6
|
|
|
|
|
| TS 11
|
| International Food Information Council Foundation
|
| Vol #:
|
| 6
|
|
|
|
|
| TS 12
|
| Physicians Committee for Responsible Medicine
|
| Vol #:
|
| 6
|
|
|
|
|
| TS
13
|
| Center for Science in the Public Interest
|
| Vol #:
|
| 6
|
|
|
|
|
| TS
14
|
| The Sugar Association
|
| Vol #:
|
| 6
|
|
|
|
|
| TS
15
|
| Weston A Price Foundation
|
| Vol #:
|
| 6
|
|
|
|
|
| TS 16
|
| Center for Food and Nutrition Policy, Virginia Tech
|
| Vol #:
|
| 6
|
|
|
|
|
| 2003N-0483
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Food Labeling Regulations
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0387
|
| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
|
|
|
|
|
| C
1
|
| American Thyroid Assn
|
| Vol #:
|
| 1
|
|
