| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On March 1, 2005
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1980N-0208
|
| Biological Products; Bacterial Vaccines and Toxiods
|
|
|
|
|
| 2003H-0432
|
| Civil Money Penalty, Korangy Radiology Associates, PA
|
|
|
|
|
| 2004D-0484
|
| Guidance for Industry on the Role of HIV Drug Resistance Testing in Antiretroviral Drug Development
|
|
|
|
|
| 2004H-0322
|
| Civil Money Penalty Re: Ecumed Health Group, Inc.
|
|
|
|
|
| 2004N-0479
|
| Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Availability
|
|
|
|
|
| 2004N-0527
|
| Medical Devices; Medical Device Reporting
|
|
|
|
|
| 2004N-0535
|
| Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request
|
|
|
|
|
| 2005D-0043
|
| Blood Pressure Measurement Devices (Sphygmomanometers) - Accuracy; Draft Revised Compliance Policy Guide
|
|
|
|
|
| 2005D-0047
|
| Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
|
|
|
|
|
| 2005D-0057
|
| Reviewer Guidance on Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review; Availability
|
|
|
|
|
| 2005N-0038
|
| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
|
|
|
|
|
| 2005N-0049
|
| Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability
|
|
|
|
|
| 2005P-0090
|
| to amend or revoke 5 CFR 5501.101(c)(2) based upon a review of the basis,intended purpose and actural societal needs
|
|
|
|
|
| 1980N-0208
|
| Biological Products; Bacterial Vaccines and Toxiods
|
|
|
|
|
| EC 29
|
| Mr. James Sparks
|
| Vol #:
|
| 140
|
|
|
|
|
| 2003H-0432
|
| Civil Money Penalty, Korangy Radiology Associates, PA
|
|
|
|
|
| BRF
3
|
| GCF-1 (Center for Devices and Radiological Health)
|
| Vol #:
|
| 8
|
|
|
|
|
| 2004D-0484
|
| Guidance for Industry on the Role of HIV Drug Resistance Testing in Antiretroviral Drug Development
|
|
|
|
|
| EC
1
|
| GlaxoSmithKline
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
2
|
| Stanford University
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
3
|
| Bayer Diagnostics
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
4
|
| Pharm Res
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004H-0322
|
| Civil Money Penalty Re: Ecumed Health Group, Inc.
|
|
|
|
|
| INT
1
|
| Ecumed Health Group, Amador Reyes, Juan C. Carrrai, Richard W. Stone, M.D., Erlinda E. Enriquez
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0479
|
| Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Availability
|
|
|
|
|
| C
2
|
| Cox Associates Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| C
3
|
| Animal Health Institute (AHI)
|
| Vol #:
|
| 1
|
|
|
|
|
| C
4
|
| National Turkey Federation
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
2
|
| Keep Antibiotics Working
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0527
|
| Medical Devices; Medical Device Reporting
|
|
|
|
|
| NFR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| NPR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2004N-0535
|
| Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request
|
|
|
|
|
| EC
3
|
| Pharm Res and Mfrs of America
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
4
|
| Public Citizen's Health Research Group
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
5
|
| Ethicon Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0043
|
| Blood Pressure Measurement Devices (Sphygmomanometers) - Accuracy; Draft Revised Compliance Policy Guide
|
|
|
|
|
| GDL
1
|
| GUIDANCE
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0047
|
| Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
|
|
|
|
|
| GDL
1
|
| GUIDANCE
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0057
|
| Reviewer Guidance on Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review; Availability
|
|
|
|
|
| GDL
1
|
| GUIDANCE
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0038
|
| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
|
|
|
| EAPE 132
|
| McGillivray, Barbara
|
| Vol #:
|
| 1
|
|
|
|
|
| EAPE 134
|
| Krosnick, Steven
|
| Vol #:
|
| 1
|
|
|
|
|
| EAPE 135
|
| Trapani, Michael
|
| Vol #:
|
| 1
|
|
|
|
|
| EAPE 136
|
| Barnard, Deborah
|
| Vol #:
|
| 1
|
|
|
|
|
| EAPE 137
|
| Hoffman, Susie
|
| Vol #:
|
| 1
|
|
|
|
|
| EAPE 138
|
| Wallis, Wayne Jack
|
| Vol #:
|
| 1
|
|
|
|
|
| EAPE 139
|
| Veizis, Alex
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0049
|
| Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0090
|
| to amend or revoke 5 CFR 5501.101(c)(2) based upon a review of the basis,intended purpose and actural societal needs
|
|
|
|
|
| ACK
1
|
| HFA-305 to Arthur K. Yellin
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| Arthur K. Yellin
|
| Vol #:
|
| 1
|
|
