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Dockets Management

Dockets Entered On June 5, 2007
Docket # Title
1977N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products
2003N-0573 Draft Animal Cloning Risk Assessment
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
2006D-0083 Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines
2006D-0088 Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
2006E-0332 Patent Extension Application for NAMENDA (memantine hydrochloride), U.S. Patent No. 5,061,703
2006E-0333 Patent Extension Application for NAMENDA (memantine hydrochloride), U.S. Patent No. 5,614,560
2006N-0197 Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
2006N-0202 Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
2006N-0362 General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
2006P-0351 Restriction or withdrawal of the use of angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) therapy in the following conditions
2006P-0372 Determine whether Mepron (atovaquone) Tablets, 250 mg, has been voluntarily withdrawn from sale for safety or efficacy reasons
2007D-0206 Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices
2007D-0213 Guidance for Industry on Providing Regulatory Submissions in Electronic Format Receipt Date
2007E-0010 Patent Extension Application for Chantix (varenicline), U.S. Patent No. 6,410,550
2007N-0121 Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
1977N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products
SUP 58 Brian Kaplan, M.D. Vol #: 257
2003N-0573 Draft Animal Cloning Risk Assessment
C 1123 D. Clift Vol #: 68
C 1124 S. Needham Vol #: 68
C 1125 C. Gortner Vol #: 68
C 1126 D. Curtis Vol #: 68
C 1127 V. Jacobson Vol #: 68
C 1128 C. Hermance Vol #: 68
C 1129 I. Hodge Vol #: 68
C 1130 W. Lansdon Vol #: 68
C 1131 B. Thibault Vol #: 68
C 1132 S. White Vol #: 68
C 1133 M. Vojtko Vol #: 68
C 1134 T. Fortini Vol #: 68
C 1135 B. Zvolenski Vol #: 68
C 1136 P. Kauffman Vol #: 68
C 1137 M. Caponigro Vol #: 68
C 1138 P. Johnson Vol #: 68
C 1139 D. Peluso Vol #: 68
C 1140 H. Mezzadonna Vol #: 68
C 1141 K. Smith Vol #: 68
C 1142 J. Revere Vol #: 68
C 1143 P. Taboga Vol #: 68
C 1144 J. Bender Vol #: 68
C 1145 L. Scheffenacker Vol #: 68
C 1146 K. Koogler Vol #: 68
C 1147 D. Gailfus Vol #: 68
C 1148 T. Talentino Vol #: 68
C 1149 C. Allen Vol #: 68
C 1150 M. Lutz Vol #: 68
C 1151 A. Gutierrez Vol #: 68
C 1152 B. Glavin Vol #: 68
C 1153 T. Evans Vol #: 68
C 1154 C. Jones Vol #: 68
C 1155 E. Defrin Vol #: 68
C 1156 A. Lindell Vol #: 68
C 1157 R. Alpert Vol #: 68
C 1158 D. Linkowski Vol #: 68
C 1159 B. Mcallister Vol #: 68
C 1160 S. Bence Vol #: 68
C 1161 A. Anderson Vol #: 68
C 1162 A. Espiritiu Vol #: 68
C 1163 P. Knol Vol #: 68
C 1164 A. Rosen Vol #: 68
C 1165 S. Seese Vol #: 68
C 1166 M. Flietner Vol #: 68
C 1167 C. Fuenzalida Vol #: 68
C 1168 C. Micho Vol #: 68
C 1169 J. Parker Vol #: 68
C 1170 R. Sdano Vol #: 68
C 1171 C. Kuwasaki Vol #: 68
C 1172 T. Travis Vol #: 68
C 1173 C. Buitrago Vol #: 68
C 1174 T. DeCoamtis Vol #: 68
C 1175 P. Morgan Vol #: 68
C 1176 K. Olsen Vol #: 68
C 1177 J. Newfeld Vol #: 68
C 1178 K. Jacobson Vol #: 68
C 1179 E. Osgood Vol #: 68
C 1180 M. Lubeckyj Vol #: 68
C 1181 B. Vaughn Vol #: 68
C 1182 S. Adams Vol #: 68
C 1183 L. Bovasso Vol #: 68
C 1184 M. Sanders Vol #: 68
C 1185 G. Poertner Vol #: 68
C 1186 A. Messler Vol #: 68
C 1187 J. Hawthorne Vol #: 68
C 1188 W. Warren Vol #: 68
C 1189 E. Sprecher Vol #: 68
C 1190 J. Peratis Vol #: 68
C 1191 J. Mendoza Vol #: 68
C 1192 J. Nelson Vol #: 68
C 1193 B. Saxton Vol #: 68
C 1194 C. Hankinson Vol #: 68
C 1195 J. Pete Vol #: 68
C 1196 A. Paderna Vol #: 68
C 1197 F. Hill Vol #: 68
C 1198 K. Scheie Vol #: 68
C 1199 J. Valde Vol #: 68
C 1200 S. Weakly Vol #: 68
C 1201 R. Blaylock Vol #: 68
C 1202 P. Norris Vol #: 68
C 1203 P.Schulze Vol #: 68
C 1204 R. Craig Vol #: 68
C 1205 S. McVeigh Vol #: 68
C 1206 N. Brown Vol #: 68
C 1207 K. Sloan Vol #: 68
C 1208 S. Mohler Vol #: 68
C 1209 M. Smith Vol #: 68
C 1210 M. Leibich Vol #: 68
C 1211 C. Maibusch Vol #: 68
C 1212 A. Raven Vol #: 68
C 1213 K. Carpenter Vol #: 68
C 1214 Coco Vol #: 68
C 1215 R. Hartmann Vol #: 68
C 1216 T. Gaston Vol #: 68
C 1217 E. Vichules Vol #: 68
C 1218 G. Goll Vol #: 68
C 1219 L. Beavon Vol #: 68
C 1220 K. Leach Vol #: 68
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
C 742 Ministry for Foreign Affairs of Finland Vol #: 35
2006D-0083 Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines
GDL 2 Guidance Vol #: 1
2006D-0088 Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
GDL 2 Guidance Vol #: 1
2006E-0332 Patent Extension Application for NAMENDA (memantine hydrochloride), U.S. Patent No. 5,061,703
N 1 FDA Vol #: 1
2006E-0333 Patent Extension Application for NAMENDA (memantine hydrochloride), U.S. Patent No. 5,614,560
N 1 FDA Vol #: 1
2006N-0197 Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
SS 1 Supporting Statement Vol #: 1
2006N-0202 Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
NAL 1 FDA Vol #: 1
2006N-0362 General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
C 13 Gropper Neurosurgical Vol #: 1
C 14 Capital City Neurosurgical Vol #: 1
C 15 Capital City Neurosurgical Vol #: 1
C 16 University of Pennsylvania Health System Vol #: 1
C 17 University of Cincinnati Surgeons, Inc. Vol #: 1
2006P-0351 Restriction or withdrawal of the use of angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) therapy in the following conditions
SUP 1 Diplomate of the American Board of Internal Medicine & Nephrology Fulbright Scholar in Medicine Vol #: 1
2006P-0372 Determine whether Mepron (atovaquone) Tablets, 250 mg, has been voluntarily withdrawn from sale for safety or efficacy reasons
LET 2 FDA/CDER to Lachman Consultant Services Vol #: 1
2007D-0206 Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2007D-0213 Guidance for Industry on Providing Regulatory Submissions in Electronic Format Receipt Date
NAD 1 FDA Vol #: 1
2007E-0010 Patent Extension Application for Chantix (varenicline), U.S. Patent No. 6,410,550
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2007N-0121 Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
EAPE 242 REDER, Robert Vol #: 7
EAPE 243 mcvey, kevin Vol #: 7
EAPE 244 Beilic, Daniela Vol #: 7
EAPE 245 Zong, Jihong Vol #: 7
EAPE 246 Bernstein, Ilisa Vol #: 7
EAPE 247 Talton, Wayne Vol #: 7
EAPE 248 Stoddard, Jeffrey Vol #: 7
EAPE 249 Gelsinger, Timothy Vol #: 7
EAPE 250 Kapsaskis, Tony Vol #: 7
EAPE 251 Sasso, Ted Vol #: 7
EAPE 252 Sasso, Darrell Vol #: 7
EAPE 253 Liantonio, Carole Vol #: 7
EAPE 254 Kim, Michael Vol #: 7

Page created on June 5, 2007 ue

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