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Dockets Management

Dockets Entered On May 15, 2007
Docket # Title
2003N-0573 Draft Animal Cloning Risk Assessment
2004P-0464 Vitamin D & Calcium & Reduced Risk of Osteoporosis
2005D-0062 Draft Guidance FDAs Drug Watch for Emerging Drug Safety
2005D-0490 Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
2005H-0271 Civil Money Penalty: TMJ Implants, Inc.
2005N-0373 Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
2005P-0121 Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
2006E-0050 Patent Extension Application for BYETTA (exenatide injection), U.S. Patent No. 5,424,286
2006N-0525 Supplements and Other Changes to an Approved Application
2007D-0117 Guidance for Industry on Orally Disintegrating Tablets
2007N-0051 Safety of Fresh Produce; Public Hearings
2007N-0068 Medical Device User Fee and Modernization Act: Public Meeting
2007N-0114 Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
2007N-0136 Medical Devices; Immunology and Microbiology Devices; Classification of Gene Expression Profiling Test System for Breast Cancer Prognosis
2007P-0059 Withdrawal of New Animal Drug Application for Posilac - Rombinant Bovine Growth Hormone (rBGH)
2007V-0196 Laser Gunsight
2007V-0199 Laser Display Device
2003N-0573 Draft Animal Cloning Risk Assessment
EC 8141 Union of Concerned Scientists Vol #: 84
EC 8142 Union of Concerned Scientists Vol #: 88
EC 8143 Union of Concerned Scientists Vol #: 90
EC 8144 Union of Concerned Scientists Vol #: 92
2004P-0464 Vitamin D & Calcium & Reduced Risk of Osteoporosis
EC 16 American Beverage Association Vol #: 13
EC 17 National Osteoporosis Foundation Vol #: 13
EC 18 Autoimmunity Research Foundation Vol #: 13
EC 19 Autoimmunity Research Foundation Vol #: 13
EC 20 International Dairy Foods Association Vol #: 13
EC 21 GMA/FPA Vol #: 13
EC 22 Dairy Management Inc Vol #: 13
2005D-0062 Draft Guidance FDAs Drug Watch for Emerging Drug Safety
EC 22 Mr. Garry Minor Vol #: 2
EC 23 Dr. mark thoma Vol #: 2
EC 24 Miss. melina blum Vol #: 2
EC 25 Private Vol #: 2
EC 26 Ms. Kimberly Anderson Vol #: 2
EC 27 Mrs. Deborah Fisher Vol #: 2
EC 28 SAG Vol #: 2
EC 29 Mrs. Susan Trautlein Vol #: 2
EC 30 Mrs. Rhonda Van Ginkel Vol #: 2
EC 31 None Vol #: 2
EC 32 Mrs. Kristina Bedini Vol #: 2
2005D-0490 Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
C 1 Grocery Manufacturers/Food Products Association and others Vol #: 1
2005H-0271 Civil Money Penalty: TMJ Implants, Inc.
CS 26 FDA/DDM Vol #: 240
OR 24 FDA/Administrative Law Judge Vol #: 240
2005N-0373 Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
C 16 WALA Heilmittel GmbH Vol #: 9
EC 16 USA WTO TBT Inquiry Point, NIST, DOC Vol #: 8
EC 17 Mrs. Gaylene Kuintzle Vol #: 8
EC 18 Ms. Casey Baker Vol #: 1
EC 19 Ms. C Balint Vol #: 8
EC 20 Glenelg Country School Vol #: 8
EC 21 Mrs. Nancy Henry Vol #: 8
EC 22 New Zealand Embassy Vol #: 8
EC 23 St. Jude Medical Vol #: 8
2005P-0121 Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
EC 1 Columbia University Vol #: 7
EC 2 Smith Vol #: 7
2006E-0050 Patent Extension Application for BYETTA (exenatide injection), U.S. Patent No. 5,424,286
LET 5 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006N-0525 Supplements and Other Changes to an Approved Application
TS 14 Breakout Session A: Implementation of Quality by Design (QbD) CMC Pilot Program Vol #: 1
TS 15 Breakout Session B: FDA's Pharmaceutical Quality Initiative Workshop; Product & Process Developm Vol #: 1
TS 16 Modern Approach to Process Validation Vol #: 1
TS 17 Breakout Session D: Implementaiton of Quality Systems: Opportunities and Challenges Vol #: 1
TS 18 Breakout Session: ICH & International Activities (E) Vol #: 1
TS 19 Breakout Session F: Quality by Design (QbD): Risk-Based Flexible Regulatory Approaches and Regu Vol #: 1
TS 20 Breakout Session G: OGD's Question-based Review Vol #: 1
TS 21 Breakout Session: Post-Marketing Regulatory Process Vol #: 1
TS 22 Breakout Session J: Implementation of Quality Risk Management Vol #: 1
2007D-0117 Guidance for Industry on Orally Disintegrating Tablets
C 1 Akina, Inc. Vol #: 1
2007N-0051 Safety of Fresh Produce; Public Hearings
C 10 H Showalter Vol #: 2
EC 4 American Farm Bureau Federation Vol #: 2
EC 5 Mr. m scott Vol #: 2
EC 6 RARE Hospitality International Vol #: 2
EC 7 North American Bramble Growers Association Vol #: 2
EC 8 North Carolina Strawberry Association Vol #: 2
EC 9 Ms. Caroline Miles Vol #: 2
EC 10 Mr. GW Seals Vol #: 2
2007N-0068 Medical Device User Fee and Modernization Act: Public Meeting
EC 6 Mr. Marvin Loeb Vol #: 1
TR 1 Transcript of 4/30/07 Public Meeting Vol #: 2
2007N-0114 Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
EC 4 Healthcare Distribution Management Association Vol #: 2
EC 5 Mrs. phyllis Nidek Vol #: 2
EC 6 Consumers Union Vol #: 2
TS 1 Glaxo SmithKline (representing PhRMA) Vol #: 1
TS 2 Hospira (representing GPhA) Vol #: 1
TS 3 American Pharmacists Association Vol #: 1
TS 4 Thomson Healthcare Vol #: 1
TS 5 Genentech, Inc. Vol #: 1
TS 6 Healthcare Distribution Management Association Vol #: 1
2007N-0136 Medical Devices; Immunology and Microbiology Devices; Classification of Gene Expression Profiling Test System for Breast Cancer Prognosis
CCP 1 Agendia Vol #: 1
2007P-0059 Withdrawal of New Animal Drug Application for Posilac - Rombinant Bovine Growth Hormone (rBGH)
SUP 1 Cancer Prevention Coalition et al Vol #: 1
2007V-0196 Laser Gunsight
ACK 1 FDA / DDM to LaserMax Vol #: 1
VAR 1 LaserMax Vol #: 1
2007V-0199 Laser Display Device
ACK 1 Classic Sound machine Vol #: 1
ACK 2 Number not used Vol #: 1
VAR 1 Classic Sound machine Vol #: 1

Page created on May 15, 2007 ue

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