| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On December 18, 2007
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 2005D-0330
|
| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
|
|
|
|
|
| 2007D-0367
|
| Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval
|
|
|
|
|
| 2007D-0388
|
| Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protec
|
|
|
|
|
|
| 2007D-0396
|
| Drug-Induced Liver Injury: Premarketing Clinical Evaluation;Draft Guidance
|
|
|
|
|
| 2007D-0458
|
| International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex on Test for Extractable Volume of Parenteral Pr
|
|
|
|
|
|
|
|
|
| 2007D-0459
|
| International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex on Test for Particulate Contamination: Subvisib
|
|
|
|
|
|
| 2007N-0356
|
| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
|
|
|
|
|
| 2007P-0482
|
| Change the labeling for Avandia and other drugs in the thiazolidinedione class to include information that a low-fat vegan diet has an efficacy that is comparable to that of oral medications at managi
|
|
|
|
|
|
|
|
|
| 2007P-0483
|
| Restore FDA approval to Tecsana Epi-no birth trainer and to remove the adverse event report on Tecsana Epi-No from FDA website
|
|
| |
|
| 2005D-0330
|
| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
|
|
|
|
|
| GDL 2
|
| Guidance
|
| Vol #:
|
| 6
|
|
|
|
|
| NAD 2
|
| FDA
|
| Vol #:
|
| 6
|
|
|
|
|
| REF 2
|
| References
|
| Vol #:
|
| 6
|
|
|
|
|
| 2007D-0367
|
| Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval
|
|
|
|
|
| C 1
|
| David Hilfiker
|
| Vol #:
|
| 1
|
|
|
|
|
| C 2
|
| Wyeth Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| C 3
|
| Sanofi Aventis
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007D-0388
|
| Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protec
|
|
|
|
|
|
| |
|
|
|
| C 2
|
| Center for Science in the Public Interest
|
| Vol #:
|
| 1
|
|
|
|
|
| C 3
|
| Hyman, Phelps & McNamara, P.C.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007D-0396
|
| Drug-Induced Liver Injury: Premarketing Clinical Evaluation;Draft Guidance
|
|
|
|
|
| C 2
|
| Lilly Research Laboratories
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007D-0458
|
| International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex on Test for Extractable Volume of Parenteral Pr
|
|
|
|
|
|
| |
|
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007D-0459
|
| International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex on Test for Particulate Contamination: Subvisib
|
|
|
|
|
|
| |
|
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
|
