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| Dockets
Management |
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Dockets Entered On July 25,
2003 |
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Docket #
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Title
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1978N-0036D |
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OTC Antidiarrheal |
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1978N-0036L |
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OTC Laxative |
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1978N-0036T |
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Antidiarrheal Drug Products
for Over-the-Counter Human Use |
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| |
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1981N-0033P |
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Antiplaque & Antiplaque-Related
Claims |
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| |
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1996N-0417
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CGMP in Mfg. Packing or Holding
Dietary Supplements |
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| |
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1999D-1738
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Bioavilability & Bioequivalence
Studies for Nasal Aerosols |
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| |
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1999F-4372
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National Fisheries Institute
and the Louisiana Dep of Agricu |
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| |
| |
1999F-5321
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Food Safety & Inspection
service safe use of ionizing radiai |
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| |
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1999F-5322
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Ionizing Radiation for the
Treatment of Food |
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| |
| |
1999F-5522
|
|
Ionizing radiation /control
of Food-borne pathogens safe use |
|
| |
| |
1999P-2630 |
|
Establish a Daily Value for
"added sugars" |
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| |
| |
2000N-1396 |
|
Bioengineered Foods Consumed
By Humans or Animals |
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| |
| |
2000N-1571
|
|
Enrofloxacin for Poultry: Opportunity
for Hearing |
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| |
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2001F-0047
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|
Foodborne pathogens in raw-frozen-cooked-partially
cooked |
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| |
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2002D-0325 |
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Polyvinychloride using Plasticier
di-(2-ethyhexyl)phthalate |
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| |
| |
2002N-0534
|
|
Medical Device User Fee and
Modernization Act of 2002 |
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| |
| |
2002P-0506
|
|
Was Wydase (Hyaluronidase)
Inj. withdrawn for Safety Reasons |
|
| |
| |
2003D-0120
|
|
Multiplex Tests for Heritable
DNA Markers, Mutations & Expre |
|
| |
| |
2003D-0228
|
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Draft Guidance for Industry
on Continuous Marketing Applications: Pilot 1 b Reviewable Units
for Fast Track Products Under PDUFA |
|
| |
| |
2003D-0229
|
|
Draft Guidance for Industry
on Continuous Marketing Applications: Pilot 2 b Scientific Feedback
and Interactions During Development of Fast Track Products Under
PDUFA |
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2003N-0168
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|
July 31, 2003 Public Meeting
on Consumer Medication Information |
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2003N-0201
|
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Minimizing Medication Errors
- Methods for Evaluating Proprietary Names for their Confusion Potential;
Public Meeting |
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| |
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2003N-0207
|
|
Preparation for ICH Meetings
in Brussels, Belgium, July 15-18, 2003 and ICH 6 Conference in Osaka,
Japan, November 12-15, 2003 |
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| |
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2003P-0021
|
|
Withdrawal of Wydase, Hyaluronidase
Injection |
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| |
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2003P-0289 |
|
Outlaw and prohibit the use
of hydrogenated and partially hydrogenated fats in all prepared,manufactured
and processed food products intended for human consumption |
|
Contents |
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1978N-0036D
|
|
OTC antidiarrheal
|
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EMC
1 |
|
Procter & Gamble Company
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Vol #: |
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34 |
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| |
1978N-0036L
|
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OTC Laxative |
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PDN 12 |
|
HFC-1 to American Herbal Products
Association, International Aloe Science Council |
|
Vol #: |
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121 |
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1978N-0036T
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Antidiarrheal Drug Products
for Over-the-Counter Human Use |
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EMC 1 |
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Procter & Gamble Company
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Vol #: |
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1 |
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| |
|
|
1981N-0033P |
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Antiplaque & Antiplaque-Related
Claims |
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| |
C 11 |
|
Boston University Goldman School
of Dental Medicine |
|
Vol #: |
|
1 |
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| |
| |
EXT 7 |
|
Consumer Healthcare Products
Association |
|
Vol #: |
|
1 |
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| |
| |
1990N-0135 |
|
Mandatory Status of Nutrition
and Nutrient Content Revision |
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| |
BKG 5 |
|
Background Material
|
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Vol #: |
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6 |
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| |
| |
1996N-0417
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CGMP in Mfg. Packing or Holding
Dietary Supplements |
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C 129 |
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Calorie Control Council
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Vol #: |
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21 |
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C 130 |
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Herbal Answers |
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Vol #: |
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21 |
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C 131 |
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Werum Enterprises, Inc.
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Vol #: |
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21 |
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| |
| |
EMC 32 |
|
Council for Responsible Nutrition
|
|
Vol #: |
|
17 |
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| |
| |
1999D-1738
|
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Bioavailability & Bioequivalence
Studies for Nasal Aerosols |
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| |
C 23 |
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GlaxoSmithKline |
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Vol #: |
|
2 |
Attachment |
| |
| |
C 24 |
|
International Pharmaceutical
Aerosol Consortium on Regulation and Science (IPAC-RS) |
|
Vol #: |
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2 |
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| |
| |
1999F-4372
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|
National Fisheries Institute
and the Louisiana Dep of Agricu |
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| |
C 78 |
|
Public Citizen, Center for
Food Safety |
|
Vol #: |
|
8 |
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| |
| |
1999F-5321
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|
Food Safety & Inspection
service safe use of ionizing radiai |
|
| |
|
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| |
C 76 |
|
Public Citizen, Center for
Food Safety |
|
Vol #: |
|
8 |
|
| |
| |
1999F-5322
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|
Ionizing Radiation for the
Treatment of Food |
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| |
C 75 |
|
Public Citizen, Center fro
Food Safety |
|
Vol #: |
|
6 |
|
| |
| |
1999F-5522
|
|
Ionizing radiation /control
of Food-borne pathogens safe use |
|
| |
C 79 |
|
Public Citizen, Center for
Food Safety |
|
Vol #: |
|
6 |
|
| |
| |
1999P-2630 |
|
Establish a Daily Value for
"added sugars" |
|
| |
| |
EMC 482 |
|
Anne Melly |
|
Vol #: |
|
32 |
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| |
| |
2000N-1396 |
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Bioengineered Foods Consumed
By Humans or Animals |
|
| |
| |
C 9555 |
|
Carol Ann Campbell |
|
Vol #: |
|
415 |
|
| |
| |
2000N-1571
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Enrofloxacin for Poultry: Opportunity
for Hearing |
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| |
SF 5 |
|
GCF-1 |
|
Vol #: |
|
380 |
|
| |
| |
TR 10 |
|
Corrected April 29, 2003 Transcript
|
|
Vol #: |
|
382 |
|
| |
| |
2001F-0047
|
Foodborne pathogens in raw-frozen-cooked-partially
cooked |
|
|
C 74 |
|
Public Citizen, Center for
Food Safety |
|
Vol #: |
|
8 |
|
| |
| |
2002D-0325 |
|
Polyvinychloride using Plasticier
di-(2-ethyhexyl)phthalate |
|
| |
|
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| |
EMC 121 |
|
Tracy Vogtli |
|
Vol #: |
|
3 |
|
| |
| |
2002N-0534
|
|
Medical Device User Fee and
Modernization Act of 2002 |
|
| |
C 32 |
|
Orthopedic Surgical Manufacturers
Association (OSMA) |
|
Vol #: |
|
2 |
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| |
| |
C 33 |
|
Medion Diagnostics |
|
Vol #: |
|
2 |
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| |
| |
2002P-0506
|
|
Was Wydase (Hyaluronidase)
Inj. withdrawn for Safety Reasons |
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| |
C 1 |
|
Hyalozyme Therapeutics, Inc.
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Vol #: |
|
1 |
|
| |
| |
2003D-0120
|
|
Multiplex Tests for Heritable
DNA Markers, Mutations & Expre |
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| |
C 13 |
|
Orth-Clinical Diagnostics
|
|
Vol #: |
|
1 |
|
| |
| |
C 14 |
|
American College of Medical
Genetics |
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Vol #: |
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1 |
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| |
| |
C 15 |
|
American Association for Clinical
Chemistry |
|
Vol #: |
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1 |
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| |
| |
EMC 2 |
|
Wilson Sonsini Goodrich &
Rosati |
|
Vol #: |
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1 |
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| |
| |
EMC 3 |
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Epigenomics, Inc. |
|
Vol #: |
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1 |
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EMC 4 |
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GlaxoSmithKline |
|
Vol #: |
|
1 |
|
| |
| |
2003D-0228
|
|
Draft Guidance for Industry
on Continuous Marketing Applications: Pilot 1 b Reviewable Units
for Fast Track Products Under PDUFA |
|
| |
C 1 |
|
Millennium Pharmaceuticals,
Inc. |
|
Vol #: |
|
1 |
|
| |
| |
2003D-0229
|
|
Draft Guidance for Industry
on Continuous Marketing Applications: Pilot 2 b Scientific Feedback
and Interactions During Development of Fast Track Products Under
PDUFA |
|
| |
| |
C 1 |
|
Millennium Pharmaceuticals,
Inc. |
|
Vol #: |
|
1 |
|
| |
| |
2003N-0168
|
|
July 31, 2003 Public Meeting
on Consumer Medication Information |
|
| |
LET 1 |
|
Thomason MICROMEDEX
|
|
Vol #: |
|
2 |
|
| |
| |
LST 1 |
|
Tentative Agenda for July 31,
2003 meeting |
|
Vol #: |
|
2 |
|
| |
| |
TS 1 |
|
Pharmacists Planning Service,
Inc. (PPSI) |
|
Vol #: |
|
2 |
|
| |
| |
2003N-0201
|
|
Minimizing Medication Errors
- Methods for Evaluating Proprietary Names for their Confusion Potential;
Public Meeting |
|
| |
EMC 2 |
|
Consumer Healthcare Products
Association |
|
Vol #: |
|
1 |
|
| |
| |
2003N-0207
|
|
Preparation for ICH Meetings
in Brussels, Belgium, July 15-18, 2003 and ICH 6 Conference in Osaka,
Japan, November 12-15, 2003 |
|
| |
|
|
| |
TR 1 |
|
Transcript of the June 24,
2003 ICH Public Meeting |
|
Vol #: |
|
2 |
|
| |
|
|
|
|
|
|
|
|
|
| 2003P-0021
|
Withdrawal of Wydase, Hyaluronidase
Injection |
|
|
|
|
| |
C 1 |
|
Hyalozyme Therapeutics, Inc.
|
|
Vol #: |
|
1 |
|
| |
| |
LET 1 |
|
HFD-6 to Amphastar Pharmaceuticals,
Inc. |
|
Vol #: |
|
1 |
|
| |
| |
2003P-0289 |
|
outlaw and prohibit the use
of hydrogenated and partially hydrogenated fats in all prepared,manufactured
and processed food products intended for human consumption |
|
| |
| |
C 1 |
|
Alvin D Hofer |
|
Vol #: |
|
1 |
|
|
