| | | | | | | | | | |
|
|
| Dockets Entered
On August 9, 2007
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 2001D-0286
|
| In Vitro HIV Drug Resistance Genotype Assays [510(k)s]
|
|
|
| 2002D-0081
|
| Hepatitis B Surface Antigen (HBSAG) Assays to Test Blood
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
| 2005H-0271
|
| Civil Money Penalty: TMJ Implants, Inc.
|
|
|
| 2005N-0272
|
| Irradiation in the Production, Processing & Handling of Food
|
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
| 2006N-0454
|
| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
|
|
|
| 2006P-0302
|
| Permit the filing of an ANDA Suitability for Sodium Chloride Injection
|
|
|
| 2007D-0125
|
| Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
|
|
|
| 2007D-0213
|
| Guidance for Industry on Providing Regulatory Submissions in Electronic Format Receipt Date
|
|
|
| 2007D-0268
|
| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology
|
|
|
|
| 2007N-0050
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Label Comprehension Study
|
|
|
| 2007N-0179
|
| Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges; Public Workshop
|
|
|
| 2007P-0097
|
| Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
|
|
|
|
|
|
| 2007P-0187
|
| Requirements of Iodized Salt on Ingredient Labels
|
|
|
| 2007P-0282
|
| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
|
|
|
| 2001D-0286
|
| In Vitro HIV Drug Resistance Genotype Assays [510(k)s]
|
|
|
| REF 1
|
| References
|
| Vol #:
|
| 2
|
|
|
| 2002D-0081
|
| Hepatitis B Surface Antigen (HBSAG) Assays to Test Blood
|
|
|
| REF 1
|
| References
|
| Vol #:
|
| 2
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
| C 4
|
| C. Harris
|
| Vol #:
|
| 3
|
|
|
| 2005H-0271
|
| Civil Money Penalty: TMJ Implants, Inc.
|
|
|
| CS 28
|
| FDA/DDM
|
| Vol #:
|
| 245
|
|
|
| OR 25
|
| FDA/Administrative Law Judge
|
| Vol #:
|
| 245
|
|
|
| 2005N-0272
|
| Irradiation in the Production, Processing & Handling of Food
|
|
|
| C 3622
|
| MDS Nordion
|
| Vol #:
|
| 47
|
|
|
| C 3623
|
| Unknown
|
| Vol #:
|
| 47
|
|
|
| C 3624
|
| J. Herd
|
| Vol #:
|
| 47
|
|
|
| C 3625
|
| B. Sanders
|
| Vol #:
|
| 47
|
|
|
| C 3626
|
| S. Yerger
|
| Vol #:
|
| 47
|
|
|
| C 3627
|
| L. Risdon
|
| Vol #:
|
| 47
|
|
| | | | | | | | |
|
|
| EC 3
|
| Sanofi Pasteur
|
| Vol #:
|
| 1
|
|
|
| EC 4
|
| sanofi-aventis
|
| Vol #:
|
| 1
|
|
|
| 2007D-0268
|
| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology
|
|
|
|
|
|
|
| EC 1
|
| Ms. Renee Cummings
|
| Vol #:
|
| 1
|
|
|
| 2007N-0050
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Label Comprehension Study
|
|
|
| EC 5
|
| Mr. bill wells
|
| Vol #:
|
| 1
|
|
|
| 2007N-0179
|
| Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges; Public Workshop
|
|
|
| EC 4
|
| American Society of Health-System Pharmacists
|
| Vol #:
|
| 1
|
|
|
| EC 5
|
| Healthcare Distribution Management Association
|
| Vol #:
|
| 1
|
|
|
| EC 6
|
| Academy of Managed Care Pharmacy
|
| Vol #:
|
| 1
|
|
|
| EC 7
|
| NACDS
|
| Vol #:
|
| 1
|
|
|
| 2007P-0097
|
| Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
|
|
|
|
| |
|
| EC 5
|
| Mrs. Lisa Letarte
|
| Vol #:
|
| 1
|
|
|
| 2007P-0187
|
| Requirements of Iodized Salt on Ingredient Labels
|
|
|
| EC 1
|
| Mrs. Lucinda Brisendine
|
| Vol #:
|
| 1
|
|
|
| 2007P-0282
|
| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
|
|
|
| EC 1
|
| Massachusetts Institute of Technology
|
| Vol #:
|
| 1
|
|
|
| EC 2
|
| Ms. Pat Mainer
|
| Vol #:
|
| 1
|
|
|
| EC 3
|
| Mr. Joshua Rosen
|
| Vol #:
|
| 1
|
|