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| Dockets Entered
On October 29, 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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| 1998E-1217
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| Patent Extension, Topomax, 4,513,006
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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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| 2005P-0450
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| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
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| 2006N-0278
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Develo
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| 2006P-0334
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| Reclassification Petition fo Bone Heterografts
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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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| 2007D-0201
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| Guidance for Industry and Food and Drug Administration Staff; Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents
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| 2007D-0266
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| IQ-10 Pharmaceutical Quality System;International Conference on Harmonisation; Draft Guidance
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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-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| 2007P-0044
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| Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis
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| 2007P-0074
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| Over-the-Counter (OTC) Cough and Cold Drug Products for Children Under 6 Years of Age
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| 2007P-0399
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| Adopt, announce, and implement a consistent, CDER-wide standard for the acceptable level of 14-hydroxycodeinone impurity in oxycodone HCI API approved by FDA for use in drug products
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| 2007P-0416
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| To promulgate regulations defining human milk to be a food, and for the conditation of neonatal prematurity, a medical food
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| 2007P-0418
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| Prevention of False and Misleading Labeling and Promotion of Safe and Efficacious Use of Dronabinol
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| 2007P-0420
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| Issue a guidance document for the accelerated approval of drugs and biologics that are intended to treat rare cancers, including alveolar soft part sarcom
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| 1978N-0038
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| Sunscreen Drug Products
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| EREG 7
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| P. Zettler
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| Vol #:
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| 162
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| EREG 8
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| T. Wozniak
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| Vol #:
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| 162
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| 1998E-1217
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| Patent Extension, Topomax, 4,513,006
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| LET 4
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| Public Citizen
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| Vol #:
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| 1
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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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| GDL 2
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| Guidance for Industry
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| Vol #:
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| 1
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| NAD 2
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| FDA
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| Vol #:
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| 1
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| 2005P-0450
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| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
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| NHC 1
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| FDA
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| Vol #:
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| 1
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| 2006N-0278
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Develo
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| |
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| SS 1
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| FDA
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| Vol #:
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| 1
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| 2006P-0334
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| Reclassification Petition fo Bone Heterografts
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| LET 1
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| FDA/CDRH
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| Vol #:
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| 1
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| LET 2
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| FDA/CDRH
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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 475
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| J. J. Griffith
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| Vol #:
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| 12
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| C 476
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| K. Bastian
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| Vol #:
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| 12
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| C 477
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| Unknown
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| Vol #:
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| 12
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| C 478
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| S. K. Clark
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| Vol #:
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| 12
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| C 479
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| J. Barabino
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| Vol #:
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| 12
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| C 480
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| B. B. Buckius
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| Vol #:
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| 12
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| 2007D-0201
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| Guidance for Industry and Food and Drug Administration Staff; Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents
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| C 5
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| ENVIRONMENTAL RESEARCH CENTER
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| Vol #:
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| 1
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| 2007D-0266
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| IQ-10 Pharmaceutical Quality System;International Conference on Harmonisation; Draft Guidance
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| C 4
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| ISPE
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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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| GDL 1
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| Guidance for Industry
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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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| 2007N-0356
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| Behind The Counter
Availabilty of Certain Drugs; Public Meeting
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| EAPE 199
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| McNeil Consumer Healthcare
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| Vol #:
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| 1
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| EAPE 200
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| PEGUS Research
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| Vol #:
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| 1
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| EAPE 201
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| PEGUS Research
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| Vol #:
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| 1
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| EAPE 202
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| NARAL Pro-Choice America
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| Vol #:
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| 1
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| EAPE 203
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| CDER
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| Vol #:
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| 1
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| EAPE 204
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| NACDS
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| Vol #:
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| 1
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| EAPE 205
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| American Pharmacists Association
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| Vol #:
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| 1
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| EAPE 206
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| Synergy Research Inc.
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| Vol #:
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| 1
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| EAPE 207
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| Synergy Research Inc.
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| Vol #:
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| 1
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| EAPE 208
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| National Community Pharmacists Association
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| Vol #:
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| 1
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| 2007P-0044
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| Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis
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| C 3
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| Public Citizen
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| Vol #:
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| 1
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| 2007P-0074
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| Over-the-Counter (OTC) Cough and Cold Drug Products for Children Under 6 Years of Age
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| LET 12
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| Kerri Klein
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| Vol #:
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| 1
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| 2007P-0399
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| Adopt, announce, and implement a consistent, CDER-wide standard for the acceptable level of 14-hydroxycodeinone impurity in oxycodone HCI API approved by FDA for use in drug products
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| | | | | | | | |
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| LET 1
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| PURDUE PHARMA L.P.
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| Vol #:
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| 1
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| 2007P-0416
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| To promulgate regulations defining human milk to be a food, and for the conditation of neonatal prematurity, a medical food
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| ACK 1
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| FDA/ DDM/ to Prolacta Bioscience
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| Vol #:
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| 1
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| C 1
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| Prolacta Bioscience
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| Vol #:
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| 1
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| CP 1
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| Prolacta Bioscience
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| Vol #:
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| 1
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| 2007P-0418
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| Prevention of False and Misleading Labeling and Promotion of Safe and Efficacious Use of Dronabinol
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| ACK 1
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| FDA/DDM to Solvay Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| CP 1
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| Solvay Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2007P-0420
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| Issue a guidance document for the accelerated approval of drugs and biologics that are intended to treat rare cancers, including alveolar soft part sarcom
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|
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| ACK 1
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| FDA/DDM to The Al Aginst Alveolar Soft Part Sarcoma and The Sarcoma Foundation of America
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| Vol #:
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| 1
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| CP 1
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| The Alliance Aginst Alveolar Soft Part Sarcoma and The Sarcoma Foundation of America
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| Vol #:
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| 1
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