| | | | | | | | | | |
|
|
| Dockets Entered
On September 22, 2003
Table of Contents
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 2003D-0060
|
| Part11, Electronic records, electronic signatures scope
|
|
|
| 2003D-0163
|
| Blood Product Safety in Cases of Suspected SARS,Severe Acute
|
|
|
| 2003D-0379
|
| Draft Guidance for Industry on Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition; Availability
|
|
|
| 2003D-0380
|
| Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability
|
|
|
| 2003D-0382
|
| Draft Guidance for Industry on Sterile Drug Products Produced by Aseptic Processing
|
|
|
| 2003D-0385
|
| Guidance for Industry: Comparability Protocols b
|
|
|
| 2003D-0386
|
| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
|
|
|
| 2003H-0432
|
| Civil Money Penalty, Korangy Radiology Associates, PA
|
|
|
| 2003V-0435
|
| Laser Light Show
|
|
|
| 2003D-0060
|
| Part11, Electronic records, electronic signatures scope
|
|
|
| GDL
2
|
| Final Guidance
|
| Vol #:
|
| 1
|
|
|
| NAD
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003D-0163
|
| Blood Product Safety in Cases of Suspected SARS,Severe Acute
|
|
|
| GDL
2
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
| NAD
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003D-0379
|
| Draft Guidance for Industry on Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition; Availability
|
|
|
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003D-0380
|
| Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability
|
|
|
| GDL
1
|
| Draft Guidance
|
| Vol #:
|
| 1
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003D-0382
|
| Draft Guidance for Industry on Sterile Drug Products Produced by Aseptic Processing
|
|
|
| GDL
1
|
| Draft Guidance
|
| Vol #:
|
| 1
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003D-0385
|
| Guidance for Industry: Comparability Protocols b
|
|
|
| GDL
1
|
| Draft Guidance
|
| Vol #:
|
| 1
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003D-0386
|
| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
|
|
|
| GDL
1
|
| Draft Guidance
|
| Vol #:
|
| 1
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003H-0432
|
| Civil Money Penalty, Korangy Radiology Associates, PA
|
|