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On October 15, 2003 Table of Contents | |||||||||||
Docket # | Title | ||||||||||
1978N-0021A | Skin Protectant Drug Prod to OTC, Astringent Drug Products | ||||||||||
1978N-0038 | Sunscreen Drug Products | ||||||||||
1995N-0071 | Proposal to Debar Amirul Islam; Notice of Opportunity for He | ||||||||||
1997S-0162 | 30-Day Structure Function Claim Notification Letters Dietary | ||||||||||
1998P-0151 | Introduction Of Downed Cattle Into The Food Supply | ||||||||||
1999P-0033 | Combat the spread of transmissible spongiform encephalopathy | ||||||||||
2000D-1598 | Voluntary Labeling for Bioengineered Foods | ||||||||||
2000N-1484 | Safety Reporting Requirements Human Drug/Biological Products | ||||||||||
2002H-0443 | Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care | ||||||||||
2002N-0475 | Financial Relationships & Interest in Research Involving Hum | ||||||||||
2002P-0226 | ANDA for methotrexate sodium oral solution, 5mg/ml | ||||||||||
2003D-0165 | Current Good Manufacturing Practices for Medical Gases | ||||||||||
2003D-0319 | Guidance for Industry and FDA Staff; Draft; Premarket Assessment of Pediatric Medical Devices | ||||||||||
2003D-0434 | Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications: Effect on FDA Review Clock and Performance Assessment; Availability | ||||||||||
2003N-0066 | Inspection by Accredited Persons Under MDUFMA | ||||||||||
2003N-0076 | Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements | ||||||||||
2003N-0294 | Risk Management Plans for Opiate Analgesic Drug | ||||||||||
2003N-0295 | Agency Information Collection; Establish & Maintain List of US Dairy Product Manufacturers/Processors with interest in exporting to Chile | ||||||||||
2003N-0338 | Obesity | ||||||||||
2003N-0361 | Anti-Counterfeit Drug Initiative | ||||||||||
2003P-0270 | Prohibit False and Misleading Labeling | ||||||||||
2003P-0274 | In re Tier 1 initial Approval Program | ||||||||||
2003P-0283 | ANDA Suitable for Glimepiride Tablets, 8 mg | ||||||||||
2003P-0307 | ANDA suitability for a new strength of Warfarin Sodium Tablets, USP 1.5mg | ||||||||||
2003P-0479 | Allow importation of Canadian versions of drugs that are approved to the United States | ||||||||||
2003V-0480 | Laser Light Show | ||||||||||
1978N-0021A | Skin Protectant Drug Prod to OTC, Astringent Drug Products | ||||||||||
NCD 1 | FDA | Vol #: | 3 | ||||||||
1978N-0038 | Sunscreen Drug Products | ||||||||||
C 603 | BDF Beiersdorf, Inc. | Vol #: | 150 | ||||||||
1995N-0071 | Proposal to Debar Amirul Islam; Notice of Opportunity for He | ||||||||||
NFR 2 | FDA | Vol #: | 1 | ||||||||
1997S-0162 | 30-Day Structure Function Claim Notification Letters Dietary |
LET 11259 | Enzymatic Therapy Natural Medicines | Vol #: | 86 | ||||||
LET 11260 | PhytoPharmica Natural Medicines | Vol #: | 86 | ||||||
LET 11261 | Enzymatic Therapy Natural Medicines | Vol #: | 86 | ||||||
LET 11262 | A Way of Life, Inc. | Vol #: | 86 | ||||||
LET 11263 | Market America, Inc. | Vol #: | 86 | ||||||
LET 11264 | Pure Encapsulations, Inc. | Vol #: | 86 | ||||||
LET 11265 | Mera Pharmaceuticals | Vol #: | 86 | ||||||
LET 11266 | Taiko Pharmaceutical Co., Ltd. | Vol #: | 86 | ||||||
LET 11267 | Unicity Network, Inc. | Vol #: | 86 | ||||||
LET 11268 | Uncity Network, Inc. | Vol #: | 86 | ||||||
LET 11269 | Uncity Network, Inc. | Vol #: | 86 | ||||||
LET 11270 | Uncity Network, Inc. | Vol #: | 86 | ||||||
LET 11271 | Uncity Network, Inc. | Vol #: | 86 | ||||||
LET 11272 | Nature's Sunshine Products, Inc. | Vol #: | 86 | ||||||
LET 11273 | CCA Industries, Inc. | Vol #: | 86 | ||||||
LET 11274 | Innovative Botanical solutions, Inc. | Vol #: | 86 | ||||||
LET 11275 | Unicity Network, Inc. | Vol #: | 86 | ||||||
LET 11276 | Unicity Network, Inc. | Vol #: | 86 | ||||||
LET 11277 | Unicity Network, Inc. | Vol #: | 86 | ||||||
LET 11278 | Unicity Nertwork, Inc. | Vol #: | 86 | ||||||
LET 11279 | Unicity Network, Inc. | Vol #: | 86 | ||||||
LET 11280 | EuroPharma | Vol #: | 86 | ||||||
LET 11281 | Eu Yan Sang (hong Hong) Limited | Vol #: | 86 | ||||||
LET 11282 | CCA Industries, Inc. | Vol #: | 86 | ||||||
LET 11283 | Advanced Vision Research | Vol #: | 86 | ||||||
LET 11284 | Enzymatic Therapy Natural Medicines | Vol #: | 86 | ||||||
LET 11285 | Twin Laboratories, Inc. | Vol #: | 86 | ||||||
LET 11286 | Twin Laboratories, Inc. | Vol #: | 86 | ||||||
LET 11287 | Twin Laboratories, Inc. | Vol #: | 86 | ||||||
LET 11288 | Twin Laboratories, Inc. | Vol #: | 86 | ||||||
LET 11289 | PhytoPharmica Natural Medicines | Vol #: | 86 | ||||||
LET 11290 | Enzymatic Therapy Natural Medicines | Vol #: | 86 | ||||||
LET 11291 | Zand Herbal Formulas | Vol #: | 86 | ||||||
LET 11292 | Zand herbal Formulas | Vol #: | 86 | ||||||
1998P-0151 | Introduction Of Downed Cattle Into The Food Supply | ||||||||
C 7073 | Tina Orwig | Vol #: | 301 |
C 7074 | Elisa Frey | Vol #: | 301 | ||||||
C 7075 | Cherie Moncrief | Vol #: | 301 | ||||||
C 7076 | Elena McCracken | Vol #: | 301 | ||||||
C 7077 | Jenny Martin | Vol #: | 301 | ||||||
C 7078 | Mary Groff | Vol #: | 301 | ||||||
C 7079 | Mireya Landin et al. | Vol #: | 301 | ||||||
C 7080 | Lorraine Nicotera | Vol #: | 301 | ||||||
C 7081 | Marta M. Guzman | Vol #: | 301 | ||||||
C 7082 | Margaret Falino | Vol #: | 301 | ||||||
C 7083 | Kelly K. Brinkman | Vol #: | 301 | ||||||
C 7084 | George Allison | Vol #: | 301 | ||||||
C 7085 | Victoria Crompton | Vol #: | 301 | ||||||
1999P-0033 | Combat the spread of transmissible spongiform encephalopathy | ||||||||
C 389 | George and Donna Allison | Vol #: | 9 | ||||||
2000D-1598 | Voluntary Labeling for Bioengineered Foods | ||||||||
EMC 12014 | Char Alford | Vol #: | 574 | ||||||
2000N-1484 | Safety Reporting Requirements Human Drug/Biological Products | ||||||||
C 33 | Robert J. Reinhard | Vol #: | 4 | ||||||
C 34 | Aventis Pharmaceuticals, Inc. | Vol #: | 4 | ||||||
C 35 | Consumer healthcare Products Assn (CHPA) | Vol #: | 4 | ||||||
C 36 | GlaxoSmithKline | Vol #: | 4 | ||||||
C 37 | Luitpold Pharmaceuticals, Inc. (Luitpold) | Vol #: | 4 | ||||||
C 38 | Amgen, Inc. (Amgen) | Vol #: | 4 | ||||||
C 39 | Millennium Pharmaceuticals, Inc. | Vol #: | 4 | ||||||
C 40 | Pfizer | Vol #: | 4 | ||||||
C 41 | EMEA | Vol #: | 4 | ||||||
2002H-0443 | Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care | ||||||||
CS 17 | HFA-305 | Vol #: | 1 | ||||||
OR 15 | HF-3 | Vol #: | 1 | ||||||
2002N-0475 | Financial Relationships & Interest in Research Involving Hum | ||||||||
C 36 | Bristol-Myers Squibb Pharmaceutical Research Institute | Vol #: | 2 | ||||||
2002P-0226 | ANDA for methotrexate sodium oral solution, 5mg/ml | ||||||||
PAV 1 | HFD-600 toKirkpatrick & Lockhart LLP | Vol #: | 1 |
2003D-0165 | Current Good Manufacturing Practices for Medical Gases | ||||||||
C 25 | Essex P.B.&R Corp. (Essex) | Vol #: | 1 | ||||||
2003D-0319 | Guidance for Industry and FDA Staff; Draft; Premarket Assessment of Pediatric Medical Devices | ||||||||
C 1 | Respironics, Inc. | Vol #: | 1 | ||||||
2003D-0434 | Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications: Effect on FDA Review Clock and Performance Assessment; Availability | ||||||||
GDL 1 | Guideline | Vol #: | 1 | ||||||
NAD 1 | FDA | Vol #: | 1 | ||||||
2003N-0066 | Inspection by Accredited Persons Under MDUFMA | ||||||||
N 2 | FDA | Vol #: | 1 | ||||||
2003N-0076 | Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements | ||||||||
C 8 | Center for Science in the Public Interest (CSPI) | Vol #: | 1 | ||||||
C 9 | Center for Science in the Public Interest (CSPI) | Vol #: | 1 | ||||||
2003N-0294 | Risk Management Plans for Opiate Analgesic Drug | ||||||||
C
4 Attachment | Purdue Pharma, L.P. | Vol #: | 1 | ||||||
2003N-0295 | Agency Information Collection; Establish & Maintain List of US Dairy Product Manufacturers/Processors with interest in exporting to Chile | ||||||||
N 2 | FDA | Vol #: | 1 | ||||||
2003N-0338 | Obesity | ||||||||
NM 1 | FDA | Vol #: | 1 | ||||||
2003N-0361 | Anti-Counterfeit Drug Initiative | ||||||||
EMC 2 | Angstrom Technologies, Inc. | Vol #: | 2 | ||||||
2003P-0270 | Prohibit False and Misleading Labeling | ||||||||
C 31 | Chris Goodwin | Vol #: | 1 | ||||||
2003P-0274 | In re Tier 1 initial Approval Program | ||||||||
RC 1 | Abigail Alliance and the Washington Legal Foundation | Vol #: | 1 | ||||||
2003P-0283 | ANDA Suitable for Glimepiride Tablets, 8 mg | ||||||||
PAV 1 | HFD-600 to Lachman Consultant Services, Inc. | Vol #: | 1 | ||||||
2003P-0307 | ANDA suitability for a new strength of Warfarin Sodium Tablets, USP 1.5mg | ||||||||
PAV 1 | HFD-600 toTaro Pharmaceuticals | Vol #: | 1 | ||||||
2003P-0479 | Allow importation of Canadian versions of drugs that are approved to the United States |
ACK 1 | HFA-305 to The City of Springfield, Massachusetts | Vol #: | 1 | ||||||
CP 1 | The City of Springfield, Massachusetts | Vol #: | 1 | ||||||
2003V-0480 | Laser Light Show | ||||||||
ACK 1 | HFA-305 to Laser Design Productions Inc. | Vol #: | 1 | ||||||
VAR 1 | Laser Design Productions Inc. | Vol #: | 1 |
Page Posted October 16, 2003 dp
Page updated October 24, 2003 jb
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