| | | | | | | | | | |
|
|
| Dockets Entered
On October 6, 2006
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1980F-0398
|
| Azoniaadamantane Chloride in Paper & Paperboard
|
|
|
| 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-0297
|
| International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Availability
|
|
|
| 2006D-0331
|
| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
|
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
| 2006N-0107
|
| FDA-Regulated Products Containing Nanotechnology Materials
|
|
|
| 2006N-0219
|
| Clinical Trial Design Issues in the Development of Products for Treatment of Chronic Hepatitis C Infection
|
|
|
| 2006P-0151
|
| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
|
|
|
| 2006P-0306
|
| Publish specific requirements for applications seeking approval to market therapeutically equivalent versions of insulin and human growth hormone
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
| 1980F-0398
|
| Azoniaadamantane Chloride in Paper & Paperboard
|
|
|
| BKG 1
|
| Background Material
|
| Vol #:
|
| 1
|
|
|
| FONS 1
|
| Finding of no Significant Impact
|
| 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
|
|
|
| LET 2
|
| FDA/CFSAN to Center for Science in the Public Interest
|
| Vol #:
|
| 1
|
|
|
| 2006D-0297
|
| International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Availability
|
|
|
| EC 2
|
| Pfizer Inc.
|
| Vol #:
|
| 1
|
|
|
| 2006D-0331
|
| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
|
|
|
| TS 2
|
| FDA/OC
|
| Vol #:
|
| 2
|
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
| EC 3
|
| InterGenetics Incorporated
|
| Vol #:
|
| 1
|
|
|
| 2006N-0107
|
| FDA-Regulated Products Containing Nanotechnology Materials
|
|
|
| EC 13
|
| Project on Emerging Nanotechnologies, WWICS
|
| Vol #:
|
| 1
|
|
|
| EC 14
|
| Consumers Union
|
| Vol #:
|
| 1
|
|
|
| EC 15
|
| Mr. Jaydee Hanson
|
| Vol #:
|
| 1
|
|
|
| 2006N-0219
|
| Clinical Trial Design Issues in the Development of Products for Treatment of Chronic Hepatitis C Infection
|
|
|
| C 1
|
| Hep. C Caring Ambassadors Program
|
| Vol #:
|
| 1
|
|
|
| EC 3
|
| Harm Reduction Coalition
|
| Vol #:
|
| 1
|
|
|
| 2006P-0151
|
| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
|
|
|
| EC 737
|
| Mrs. Gloria Buchanan
|
| Vol #:
|
| 3
|
|
|
| EC 738
|
| Plateau Consulting
|
| Vol #:
|
| 3
|
|