| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On October 19, 2007
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1978N-0038
|
| Sunscreen Drug Products
|
|
|
|
|
| 2000D-0084
|
| Guidance for Industry: Special Protocol Assessment
|
|
|
|
|
| 2000N-1545
|
| Proposed Revision of Postmarketing Reporting Requirements
|
|
|
|
|
| 2005P-0450
|
| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
|
|
|
|
|
| 2006D-0079
|
| Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables
|
|
|
|
|
| 2006N-0454
|
| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
|
|
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
|
|
| 2007D-0201
|
| Guidance for Industry and Food and Drug Administration Staff; Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents
|
|
|
|
|
| 2007D-0327
|
| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Remote Medication Management System
|
|
|
|
|
| 2007D-0365
|
| Guidance for Industry on The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 Current Good Manufacturing Practice (CGMP)
|
|
|
|
|
| 2007N-0182
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Databank
|
|
|
|
|
| 2007N-0284
|
| Revision of the Requirements for Live Vaccine Processing
|
|
|
|
|
| 2007N-0328
|
| Medical Devices; General Hospital and Personal Use Devices; Classification of Remote Medication Management System
|
|
|
|
|
| 2007P-0333
|
| Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa
|
|
|
|
|
|
|
|
|
|
|
| 1978N-0038
|
| Sunscreen Drug Products
|
|
|
|
|
| EXT 12
|
| Johnson & Johnson
|
| Vol #:
|
| 162
|
|
|
|
|
| 2000D-0084
|
| Guidance for Industry: Special Protocol Assessment
|
|
|
|
|
| NAL 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| SS 2
|
| Supporting Statement
|
| Vol #:
|
| 1
|
|
|
|
|
| 2000N-1545
|
| Proposed Revision of Postmarketing Reporting Requirements
|
|
|
|
|
| NFR 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0450
|
| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
|
|
|
|
|
| REF 1
|
| Reference
|
| Vol #:
|
| 2
|
|
|
|
|
| 2006D-0079
|
| Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables
|
|
|
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| SS 1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0454
|
| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
|
|
|
|
|
| C 4230
|
| H. Opsimos
|
| Vol #:
|
| 40
|
|
|
|
|
| C 4231
|
| R. Mendell
|
| Vol #:
|
| 40
|
|
|
|
|
| C 4232
|
| M. Cozza
|
| Vol #:
|
| 40
|
|
|
|
|
| C 4233
|
| V. McDonald
|
| Vol #:
|
| 40
|
|
|
|
|
| C 4234
|
| K. Forrestal
|
| Vol #:
|
| 40
|
|
