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| Dockets Entered
On September 27, 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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| 1980P-0100
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| LIGHT SHOW PROJECTOR "RAINBOW"
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| 1997N-0497
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| Allogeneic Peripheral and Placental/ Umbilical Cord Blood
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1999D-2013
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| Cooperative Manufacturing Arrangements for Licensed
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| 2000V-0610
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| Infrared Laser Aiming Light
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| 2005D-0155
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| Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| 2006P-0307
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| To amend 21CFR 201.17 regarding expiration dates
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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-0168
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| Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations
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| 2007N-0330
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| Presidential Interagency Working Group on Import Safety; Public Meeting
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| 2007P-0097
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| 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
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| 2007P-0333
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| Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa
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| 2007P-0361
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| Approve Abbreviated New Drug Applications (ANDA's) and 505 (b)(2) applications that reference drug products containing auto-injectors-- and to make therapeutic equivalence designations---- only in acco
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| 2007P-0362
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| To determine whetherNamenda Tablets 15 mg and 20 mg (approved under NDA 21-487 owned by Forest Laboratories) were Voluntarily withdrawn from sale for reasons related to safety efficacy
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| 1978N-0038
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| Sunscreen Drug Products
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| LET 181
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| S. Whitehouse
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| Vol #:
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| 155
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| 1980P-0100
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| LIGHT SHOW PROJECTOR "RAINBOW"
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| VRA 14
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| Lynne L. Rice
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| Vol #:
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| 1
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| 1997N-0497
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| Allogeneic Peripheral and Placental/ Umbilical Cord Blood
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| SUP 10
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| Nation Marrow Donor Program (NMDP)
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| Vol #:
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| 15
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7539
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| Kristin Sperarza
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| Vol #:
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| 339
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| C 7540
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| Farm Sanctuary
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| Vol #:
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| 341
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| 1999D-2013
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| Cooperative Manufacturing Arrangements for Licensed
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| C 10
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| Plasma Protein Therapeutics Association (PPTA)
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| Vol #:
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| 1
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| 2000V-0610
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| Infrared Laser Aiming Light
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| VRA 4
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| Lynne L. Rice
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| Vol #:
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| 1
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| 2005D-0155
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| Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
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| C 1
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| ANRESCO, Inc.
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| Vol #:
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| 1
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| 2007P-0085
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| Adopt Regulations
of General Applicability to all Food Standards that would Permit Deviations
from the Requirements of the Individual Food Standards of Identity
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| C 320
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| Paula Meegan
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| Vol #:
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| 6
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| 2007P-0097
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| 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
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| C 6
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| SAWMILL CREEK VINEYARDS
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| Vol #:
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| 1
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| C 7
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| CAMAS PRAIRIE WINERY
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| Vol #:
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| 1
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| 2007P-0333
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| Strict
and immediate enforcement of performance standards contained in: 21
CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring
manufacturers to supply all information for installa
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| ACK 8
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| FDA/DDM to Jeffrey P. Frontier
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| Vol #:
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| 1
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| CP 8
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| Jeffrey P. Frontier
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| Vol #:
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| 1
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| 2007P-0361
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| Approve
Abbreviated New Drug Applications (ANDA's) and 505 (b)(2) applications
that reference drug products containing auto-injectors-- and to make
therapeutic equivalence designations----only in acco
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| ACK 1
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| FDA/DDM to King Pharmaceuticals,
Inc.
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| Vol #:
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| 1
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| CP 1
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| King Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2007P-0362
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| To determine
whetherNamenda Tablets 15 mg and 20 mg (approved under NDA 21-487 owned
by Forest Laboratories) were Voluntarily withdrawn from sale for reasons
related to safety efficacy
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| ACK 1
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| FDA/ DDM to Lachman Consultant
Services, Inc.
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| Vol #:
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| 1
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| CP 1
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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