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| Dockets Entered
On October 26, 2007
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| Docket #
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| Title
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| 1978N-0038
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| Sunscreen Drug Products
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| 1998D-1232
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| Points to Consider Guidance Documents on Assayed & Unassayed Quality Control Material
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| 2001D-0193
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| Premarket Notifications for Biological Indicators Intended
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| 2003N-0205
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| Exocrine Pancreatic Insufficiency Drug Products
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| 2005D-0047
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| Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
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| 2005D-0490
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| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2007A-0332
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| Advisory Opinion request for Mandatory Black Box warnings on all Bovine Thrombin Products
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| 2007D-0290
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| Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
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| 2007D-0364
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| Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions and Answers
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| 2007D-0393
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| Guidance for Industry: Blood Establishment Computer System Validation in the Users Facility
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| 2007N-0262
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
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| 2007N-0347
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| Information Technology Strategic Planning; Public Meeting
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| 2007N-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| 2007N-0382
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| Ramipril Capsules and 180-day generic drug exclusivity
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| 2007P-0235
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| Change the labeling requirements for eggs sold in the United States
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| 2007P-0282
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| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
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| 2007P-0414
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| Stay approval of any and all subsequent abbreviated new drug applications (ANDAs) for Acarbose Tablets 25mg, 50 mg, and 100 mg..
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| 2007V-0339
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| Laser Light Show
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| 1978N-0038
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| Sunscreen Drug Products
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| EC 2464
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| Mr. Andrew Dawson
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| Vol #:
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| 162
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| 1998D-1232
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| Points to Consider Guidance Documents on Assayed & Unassayed Quality Control Material
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| EC 9
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| Association for Molecular Pathology
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| Vol #:
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| 1
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| 2001D-0193
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| Premarket Notifications for Biological Indicators Intended
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| EC 2
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| Dr. Kris Ganter
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| Vol #:
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| 1
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| 2003N-0205
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| Exocrine Pancreatic Insufficiency Drug Products
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| N 2
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| FDA
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| Vol #:
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| 2
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| 2005D-0047
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| Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
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| REF 1
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| Reference
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| Vol #:
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| 3
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| 2005D-0490
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| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
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| ANS 2
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| FDA/CFSAN to HFM Food Service
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| Vol #:
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| 1
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| ANS 3
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| FDA/CFSAN to L. Hill
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| Vol #:
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| 1
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| ANS 4
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| FDA/CFSAN to P. Patel
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| Vol #:
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| 1
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| ANS 5
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| FDS/CFSAN to C. Ang
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| Vol #:
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| 1
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| ELET 2
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| HFM Food Service
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| Vol #:
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| 1
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| ELET 3
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| L. Hill
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| Vol #:
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| 1
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| ELET 4
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| P. Patel
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| Vol #:
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| 1
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| ELET 5
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| C. Ang
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| Vol #:
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| 1
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| C 474
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| J. Spendelow
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| Vol #:
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| 12
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| 2007A-0332
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| Advisory Opinion request for Mandatory Black Box warnings on all Bovine Thrombin Products
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| SUP 1
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| ALTON & BIRD LLP
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| Vol #:
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| 1
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| 2007D-0290
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| Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
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| EC 6
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| Baxter Healthcare Corporation
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| Vol #:
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| 1
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| EC 7
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| Baxter Healthcare Corporation
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| Vol #:
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| 1
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| EC 8
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| International Society for Cellular Therapies
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| Vol #:
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| 1
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| EC 9
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| Dr. Joyce Vasconcells
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| Vol #:
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| 1
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| 2007D-0364
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| Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions and Answers
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| GDL 1
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| Guidance
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| Vol #:
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| 1
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| NAD 1
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| FDA
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| Vol #:
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| 1
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| 2007D-0393
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| Guidance for Industry: Blood Establishment Computer System Validation in the Users Facility
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| REF 1
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| Reference
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| Vol #:
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| 2
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| 2007N-0262
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
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| EC 5
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| RRT-NPS
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| Vol #:
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| 1
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| 2007N-0347
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| Information Technology Strategic Planning; Public Meeting
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| EC 14
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| FDA/OCIO
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| Vol #:
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| 1
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| |
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| 2007N-0356
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| Behind The Counter
Availability of Certain Drugs; Public Meeting
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| EAPE 191
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| Johnson & Johnson
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| Vol #:
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| 1
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| EAPE 192
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| Blank Rome LLP
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| Vol #:
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| 1
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| EAPE 193
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| Blank Rome LLP
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| Vol #:
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| 1
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| EAPE 194
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| NonprofitEdge Consulting
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| Vol #:
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| 1
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| EAPE 195
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| American Society for Reproductive Medicine
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| Vol #:
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| 1
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| EAPE 196
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| American Society for Reproductive Medicine
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| Vol #:
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| 1
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| EAPE 197
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| Consumers Union
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| Vol #:
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| 1
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