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Dockets Management

Dockets Entered On February 22, 2007
Docket # Title
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1999E-5115 Patent Extension, ISOLEX 300, #5,035,994
1999E-5118 Patent Extension: Isolex 300, #4,714,680
2005N-0394 FDAs Communication of Drug Safety Information; Public Hearing
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2006D-0336 Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
2006E-0252 Patent Extension Application for LEVEMIR insulin detemir (rDNA origin) injection, U.S. Patent No. 5,750,497
2006E-0488 Patent Extension Application for Isolex 300 (Human Stem Cells and Monoclonal Antibodies), U.S. Patent No. 4,965,204
2006E-0489 Patent Extension Application for Isolex 300 (Human Stem Cells and Monoclonal Antibodies), U.S. Patent No. 5,130,144
2006E-0495 Patent Extension Application for Model KDR401 and KRD403 Pacemaker, U.S. Patent No. 4,958,632
2006N-0479 Insect Repellent-Sunscreen Drug Products for Over-the-Counter Human Use
2006P-0069 Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2007N-0005 Prescription Drug User Fee Act (PDUFA): Public Meeting
2007N-0016 Sentinel Network To Promote Medical Product Safety
2007P-0062 determination whether a previously listed drug Ephilized loxatin (oxaliplatin for injection) Lipophilized powder for infusion, 50 and 100 mg vials has been voluntarily withdrawn from sale for safety
2007P-0065 To increase print size of direct-to-consumer advertisements
2007V-0063 Variance for Alternate Means of Handling Interlocks - Sabeus AG-1 Laser System
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 18808 PuraPharm Corporation Vol #: 170
LET 18809 PuraPharm Corporation Vol #: 170
LET 18810 PuraPharm Corporation Vol #: 170
LET 18811 PuraPharm Corporation Vol #: 170
LET 18812 PuraPharm Corporation Vol #: 170
LET 18813 PuraPharm Corporation Vol #: 170
LET 18814 PuraPharm Corporation Vol #: 170
LET 18815 PuraPharm Corporation Vol #: 170
LET 18816 PuraPharm Corporation Vol #: 170
LET 18817 PuraPharm Corporation Vol #: 170
LET 18818 PuraPharm Corporation Vol #: 170
LET 18819 PuraPharm Corporation Vol #: 170
LET 18820 PuraPharm Corporation Vol #: 170
LET 18821 PuraPharm Corporation Vol #: 170
LET 18822 PuraPharm Corporation Vol #: 170
LET 18823 PuraPharm Corporation Vol #: 170
LET 18824 PuraPharm Corporation Vol #: 170
LET 18825 PuraPharm Corporation Vol #: 170
LET 18826 PuraPharm Corporation Vol #: 170
LET 18827 PuraPharm Corporation Vol #: 170
LET 18828 PuraPharm Corporation Vol #: 170
LET 18829 PuraPharm Corporation Vol #: 170
LET 18830 PuraPharm Corporation Vol #: 170
LET 18831 PuraPharm Corporation Vol #: 170
LET 18832 PuraPharm Corporation Vol #: 170
LET 18833 PuraPharm Corporation Vol #: 170
LET 18834 PuraPharm Corporation Vol #: 170
LET 18835 PuraPharm Corporation Vol #: 170
LET 18836 PuraPharm Corporation Vol #: 170
LET 18837 PuraPharm Corporation Vol #: 170
LET 18838 PuraPharm Corporation Vol #: 170
LET 18839 PuraPharm Corporation Vol #: 170
LET 18840 PuraPharm Corporation Vol #: 170
LET 18841 PuraPharm Corporation Vol #: 170
LET 18842 PuraPharm Corporation Vol #: 170
LET 18843 PuraPharm Corporation Vol #: 170
LET 18844 PuraPharm Corporation Vol #: 170
LET 18845 PuraPharm Corporation Vol #: 170
LET 18846 PuraPharm Corporation Vol #: 170
LET 18847 PuraPharm Corporation Vol #: 170
LET 18848 PuraPharm Corporation Vol #: 170
LET 18849 PuraPharm Corporation Vol #: 170
LET 18850 PuraPharm Corporation Vol #: 170
LET 18851 New Chapter, Inc. Vol #: 170
LET 18852 New Chapter, Inc. Vol #: 170
LET 18853 New Chapter, Inc. Vol #: 170
LET 18854 New Chapter, Inc. Vol #: 170
LET 18855 New Chapter, Inc. Vol #: 170
LET 18856 American Longevity Healthcare, Inc. Vol #: 170
LET 18857 CCA Industries, Inc. Vol #: 170
LET 18858 Anabolic Laboratories, Inc. Vol #: 170
LET 18859 Alva-Amco Pharmacal Companies, Inc. Vol #: 170
LET 18860 Nature's Way Products, Inc. Vol #: 170
LET 18861 Nature's Way Products, Inc. Vol #: 170
LET 18862 New Chapter, Inc. Vol #: 170
LET 18863 New Chapter, Inc. Vol #: 170
1999E-5115 Patent Extension, ISOLEX 300, #5,035,994
LET 3 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
1999E-5118 Patent Extension: Isolex 300, #4,714,680
LET 3 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2005N-0394 FDAs Communication of Drug Safety Information; Public Hearing
C 521 S. West Vol #: 9
C 522 V. St. Onge Vol #: 9
C 523 J. Lewis Vol #: 9
C 524 L. Ferrell Vol #: 9
C 525 L. Matteson Vol #: 9
C 526 R. Beucler Vol #: 9
C 527 S. Wolfe Vol #: 9
C 528 M. Durkee Vol #: 9
C 529 H. Fricke Vol #: 9
C 530 J. Gage Vol #: 9
C 531 C. Watkins Vol #: 9
C 532 A. Peca Vol #: 9
C 533 B. Fidler Vol #: 9
C 534 J. Graff Vol #: 9
C 535 R. Land Vol #: 9
C 536 J. Cavufel Vol #: 9
C 537 E. McKenna Vol #: 9
C 538 A. Turnbull Vol #: 9
C 539 T. Curler Vol #: 9
C 540 L. Hopper Vol #: 9
C 541 Form Letter Count 400 Vol #: 10
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 18259 K. Mezarno Vol #: 198
C 18260 K. Pautler Vol #: 198
2006D-0336 Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
C 5 College of American Pathologists Vol #: 1
2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
C 3 BlueCross BlueShield Association Vol #: 1
EC 19 Association for Molecular Pathology Vol #: 1
EC 20 American Clinical Laboratory Association Vol #: 1
EC 21 Exagen Diagnostics, Inc. Vol #: 1
EC 22 Genzyme Genetics Vol #: 1
EC 23 Mr. David Levison Vol #: 1
EC 24 Mr. Jonathan Cohen Vol #: 1
2006E-0252 Patent Extension Application for LEVEMIR insulin detemir (rDNA origin) injection, U.S. Patent No. 5,750,497
N 1 FDA Vol #: 1
2006E-0488 Patent Extension Application for Isolex 300 (Human Stem Cells and Monoclonal Antibodies), U.S. Patent No. 4,965,204
LET 1 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0489 Patent Extension Application for Isolex 300 (Human Stem Cells and Monoclonal Antibodies), U.S. Patent No. 5,130,144
LET 2 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0495 Patent Extension Application for Model KDR401 and KRD403 Pacemaker, U.S. Patent No. 4,958,632
LET 2 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006N-0479 Insect Repellent-Sunscreen Drug Products for Over-the-Counter Human Use
BKG 1 Background Vol #: 2
NRD 1 FDA Vol #: 1
2006P-0069 Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
BKG 1 Background Information for NPR1 Vol #: 3
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 56 K. Norris Vol #: 6
2007N-0005 Prescription Drug User Fee Act (PDUFA): Public Meeting
EC 2 Consumers Union Vol #: 1
EC 3 ISPE Vol #: 2
EC 4 Dr. Alan Wasserman Vol #: 2
SUP 1 Coalition for Healthcare Communication Vol #: 2
TS 19 Pharmaceutical Research and Manufacturers of American (PhRMA) Vol #: 2
TS 20 Parkinson Pipeline Project Vol #: 2
2007N-0016 Sentinel Network To Promote Medical Product Safety
EAPE 221 Brown, Jeffrey Vol #: 1
EAPE 222 Feight, Andrea Vol #: 1
EAPE 223 Weaver, Brian Vol #: 1
EAPE 224 Herron, Margo Vol #: 1
EAPE 225 Dowd, Thomas Vol #: 1
EAPE 226 Rubinstein, Wade Vol #: 1
EAPE 227 Lehrer, Arthur Vol #: 1
EAPE 228 Breggar, Michael Vol #: 1
EAPE 229 Kleinfelter, William Vol #: 1
EAPE 230 Morris, Mitchell Vol #: 1
EAPE 231 Kearns, David Vol #: 1
EAPE 232 Wells, Barbara Vol #: 1
EAPE 233 Nelson , Martin Vol #: 1
EAPE 234 Seib, Aaron Vol #: 1
EAPE 235 Secunda, Jeffrey Vol #: 1
EAPE 236 Birmingham, Robert Vol #: 1
EAPE 237 Keller, James Vol #: 1
EAPE 238 Wechsler, Jill Vol #: 1
EAPE 239 Ginsberg, David Vol #: 1
EAPE 240 Stevinson, Michael Vol #: 1
EAPE 241 Farup, Christina Vol #: 1
EAPE 242 whitehead, james Vol #: 1
EAPE 243 Brady, Sean Vol #: 1
EAPE 244 Overhage, Marc Vol #: 1
EAPE 245 Eguale, Tewodros Vol #: 1
EAPE 246 Schondelmeyer, Stephen Vol #: 1
EAPE 247 Pakhomov, Serguei Vol #: 1
EAPE 248 West, Suzanne Vol #: 1
EAPE 249 Sacks, Eric Vol #: 1
EAPE 250 Diamond, maria Vol #: 1
EAPE 251 Wiley, Robin Vol #: 1
EAPE 252 Connaughton, Tom Vol #: 1
EAPE 253 Thompson, Penny Vol #: 1
EAPE 254 Ruggieri, Alexander Vol #: 1
EAPE 255 Powell, Tina Vol #: 1
EAPE 256 Jain, Susheel Vol #: 1
EAPE 257 Fu, Darrick Vol #: 1
EAPE 258 Mechanic, Robert Vol #: 1
EAPE 259 Deemer, Cameron Vol #: 1
EAPE 260 Alt, Dan Vol #: 1
EAPE 261 Gardner, Jennifer Vol #: 1
2007P-0062 determination whether a previously listed drug Ephilized loxatin (oxaliplatin for injection) Lipophilized powder for infusion, 50 and 100 mg vials has been voluntarily withdrawn from sale for safety
ACK 1 FDA / DDM to Regulus PharmaceuticalConsulting, Inc. Vol #: 1
CP 1 Regulus PharmaceuticalConsulting, Inc. Vol #: 1
2007P-0065 To increase print size of direct-to-consumer advertisements
CP 1 Pharmacists Planning Service, Inc. Vol #: 1
2007V-0063 Variance for Alternate Means of Handling Interlocks - Sabeus AG-1 Laser System
ACK 1 FDA/DDM to Sabeus, Inc. Vol #: 1
VAR 1 Sabeus, Inc. Vol #: 1

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