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Dockets Management

Dockets Entered On October 16, 2006
Table of Contents
Docket # Title
1996N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
2002F-0316 Safe Use of Mix of Bacteriofages/Antimicrobial Agent
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2004P-0074 oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2006D-0268 Guidance for Industry: Development of Preventive HIV Vaccines for Use in Pediatric Populations
2006D-0296 International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Annex on Residue on Ignition/Sulphated Ash General Chapter;
2006D-0297 International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Availability
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
2006P-0151 Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2006P-0417 Permit the Filing of an ANDA Suitability for Doxycycline Monohydrate Tablets
2006Q-0091 Qualified Health Claim (QHC): Unsaturated Fatty Acids from Canola Oil and Reduced Risk of Coronary Heart Disease
1996N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements
EMC 265 Diagnostic Chemicals, Ltd. (Canada) Vol #: 43
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
EMC 4432 S. Weinstock Vol #: 320
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
EMC 1333 M. Byrnes Vol #: 6
EMC 1334 Bressler Group Vol #: 6
2002F-0316 Safe Use of Mix of Bacteriofages/Antimicrobial Agent
OB 70 FDA-Phoenix Office Vol #: 1
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 707 L. Shore Vol #: 10
EMC 708 D. Nieliwocki Vol #: 10
EMC 709 Calorie Control Council Vol #: 10
EMC 710 R. Thompson Vol #: 10
EMC 711 F. Sturtevant Vol #: 10
EMC 712 F. Sturtevant Vol #: 10
EMC 713 F. Sturtevant Vol #: 10
EMC 714 N. Lowery Vol #: 10
EMC 715 J. Garst Vol #: 10
EMC 716 F. Sturtevant Vol #: 10
EMC 717 Calorie Control Council Vol #: 10
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 1356 M. Wilkerson Vol #: 12
EMC 1357 M. Clark Vol #: 12
EMC 1358 R. Schecker Vol #: 12
2004P-0074 oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
C 8 Frommer Larence & Haug LLP Vol #: 1
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
EMC 304 M. G. P. Ingreidents, Inc. Vol #: 23
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
EMC 3983 C. Burnham Vol #: 195
EMC 3984 L. Feher Vol #: 195
EMC 3985 C. Collins Vol #: 195
EMC 3986 R. Carr Vol #: 195
EMC 3987 B. Glynn Vol #: 195
EMC 3988 L. Runyon Vol #: 195
EMC 3989 D. Fout Vol #: 195
EMC 3990 G. Love Vol #: 195
EMC 3991 J. Wirt Vol #: 195
EMC 3992 G. Williams Vol #: 195
EMC 3993 D. Green Vol #: 195
EMC 3994 D. McNeely Vol #: 195
EMC 3995 C. Weldy Vol #: 195
EMC 3996 M. Maiorana Vol #: 195
EMC 3997 E. Baas Vol #: 195
EMC 3998 T. Zimmerman Vol #: 195
EMC 3999 D. Cunningham Vol #: 195
EMC 4000 E. Patterson Vol #: 195
EMC 4001 C. Cannon Vol #: 195
EMC 4002 E. Caldwell Vol #: 195
EMC 4003 S. Galloway Vol #: 195
EMC 4004 J. Pitts Vol #: 195
EMC 4005 V. Batty Vol #: 195
EMC 4006 P. Burke Vol #: 195
EMC 4007 L. Walters Vol #: 195
2006D-0268 Guidance for Industry: Development of Preventive HIV Vaccines for Use in Pediatric Populations
EMC 2 R. Reinhard Vol #: 1
2006D-0296 International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Annex on Residue on Ignition/Sulphated Ash General Chapter;
EMC 1 Merck Research Laboratories/U. S. Regulatory Policy Vol #: 2
2006D-0297 International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Availability
EMC 1 Merck Research Laboratories/U. S. Regulatory Policy Vol #: 2
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
EMC 372 Center for the Healing Arts Vol #: 6
EMC 373 R. Rousseau Vol #: 6
EMC 374 L. Lawhorn Vol #: 6
EMC 375 The Centre for Dentistry at Haddon Vol #: 6
EMC 376 K. Harner Vol #: 6
EMC 377 G. Layton Vol #: 6
EMC 378 D. Simone Vol #: 6
EMC 379 D. Strater Vol #: 6
EMC 380 G. Layton Vol #: 6
EMC 381 A. Morrell Vol #: 6
EMC 382 E. Nanstiel Vol #: 6
EMC 383 D. Salwa Vol #: 6
EMC 384 M. Mallasch Vol #: 6
EMC 385 L. Cifelli Vol #: 6
EMC 386 Dental Amalgam Mercury Syndrome Vol #: 6
EMC 387 C. Hamerton Vol #: 6
EMC 388 Dental Amalgam Mercury Syndrome Vol #: 6
EMC 389 S. Gold Vol #: 6
EMC 390 R. Hodgert Vol #: 6
EMC 391 N. Oakes Vol #: 6
EMC 392 N. Oakes Vol #: 6
EMC 393 F. Smith Vol #: 6
EMC 394 F. Winiski Vol #: 6
EMC 395 A. Foos Vol #: 6
EMC 396 D. Simone Vol #: 6
2006P-0151 Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
EMC 3 National Center for Women & Families Vol #: 5
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 5 Michigan State University Vol #: 1
2006P-0417 Permit the Filing of an ANDA Suitability for Doxycycline Monohydrate Tablets
ACK 1 FDA /DDM to Lachman Consultant Services, Inc. Vol #: 1
CP 1 Lachman Consultant Services, Inc. Vol #: 1
2006Q-0091 Qualified Health Claim (QHC): Unsaturated Fatty Acids from Canola Oil and Reduced Risk of Coronary Heart Disease
EMC 1 B. Martini Vol #: 7
EMC 2 B. Martini Vol #: 7

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