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Dockets Management

Dockets Entered On June 25, 2007
Docket # Title
1999D-1651 Chemistry,Mfging/Control Changes to an approved NADA/ANADA
1999P-2630 Establish a Daily Value for "added sugars"
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
2005N-0272 Irradiation in the Production, Processing & Handling of Food
2005N-0373 Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
2005P-0402 Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic-depressive illness."
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
2006D-0480 Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food D Drug Administration
2006P-0201 Cefotan (cefotetan injection), equivalent 1 g base/vial and 2 g base/vial, mfged by AstraZeneca has been voluntarily withdrawn from sale for safety and efficacy reasons
2006P-0379 To urge the FDA's prompt action to cancel the GRAS desgnation for diacetyl
2006P-0387 Declare That Clobetasol Propionate from, 0.05% is suitable for submission in an ANDA.
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2006P-0415 Petition Seeking Regulation of Cloned Animals
2006P-0428 Combivent (ipratropium bromide and albuterol sulfate)
2006P-0513 Determine that the Reference Listed Drug, Hydrochlorothiazide Tablets USP 100 mg, was voluntarily discontinued from sale in the US for reasons other than safety or effectiveness
2006P-0520 Determination for Methotrexate Injection, USP, Preservative Free, Eq. 500 mg base/20 mL, NDA 11-719)
2006P-0522 Apply Bioequivalence Requirements Consistent with 21 CFR 320.24(b)(4) to any ANDA for a Generic Drug Product using Lidoderm as its RLD
2006P-0523 Require ANDA applicant for generic of Eloxatin solution as reference drug to perform clinical testing
2006P-0524 Withdrawal of Approval of and recall all available stock of Ziana
2007D-0089 Guidance for Industry and Review Staff on Target Product Profile A Strategic Development Process Tool
2007N-0005 Prescription Drug User Fee Act (PDUFA): Public Meeting
2007N-0121 Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
2007N-0123 Amlodipine Abbreviated New Drug Application Approvals
2007N-0186 Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
2007P-0085 Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
2007P-0251 Petition for a policy statement requiring that all future advisory committee meetings discussing specific products include an oral scientific presentation by FDA staff on the products reviewed, including a thorough safety and efficacy assessment
1999D-1651 Chemistry,Mfging/Control Changes to an approved NADA/ANADA
EMC 1 B. Sachau Vol #: 1
1999P-2630 Establish a Daily Value for "added sugars"
EMC 812 B. Bowman Vol #: 33
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 824 Mission Possible International Vol #: 11
EMC 825 Mission Possible International Vol #: 11
EMC 826 Mission Possible International Vol #: 11
EMC 827 Mission Possible International Vol #: 11
EMC 828 Mission Possible International Vol #: 11
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 1500 L. Christenson Vol #: 12
EMC 1501 G. Newman Vol #: 12
EMC 1502 M. Rigby Vol #: 12
EMC 1503 B. Reid Vol #: 12
EMC 1504 N. Cornett Vol #: 12
2005N-0272 Irradiation in the Production, Processing & Handling of Food
C 136 SecureFoods, Inc. Vol #: 8
C 137 R. & V. Kell Vol #: 8
C 138 Juice Products Association Vol #: 8
C 139 M. Taylor Vol #: 8
C 140 Honest Weight Food Co-op Vol #: 8
C 141 J. Shelby Vol #: 8
C 142 B. Williams Vol #: 8
C 143 C. Boyd Vol #: 8
C 144 D. Passieri Vol #: 8
C 145 C. Sheehan Vol #: 8
C 146 R. Eustice Vol #: 8
C 147 Talkeethia Environmental Center Vol #: 8
EREG 900 C. Walton Vol #: 7
EREG 901 J. Sherwood Vol #: 7
EREG 902 K. Donnelly Vol #: 7
EREG 903 H. Ernst Vol #: 7
EREG 904 L. Humphreys Vol #: 7
EREG 905 R. Hooper Vol #: 7
EREG 906 G. Ferber Vol #: 7
EREG 907 S. Scherer Vol #: 7
EREG 908 J. Poole Vol #: 7
EREG 909 D. Sprague Vol #: 7
EREG 910 L. Rebecca Vol #: 7
EREG 911 P. C. C. Vol #: 7
EREG 912 C. Maxson Vol #: 7
EREG 913 Canz, LLC Vol #: 7
EREG 914 D. Rosencrans Vol #: 7
EREG 915 Earthbound Farm Vol #: 7
EREG 916 J. Altman Vol #: 7
EREG 917 R. Blondell Vol #: 7
EREG 918 J. Cohen Vol #: 7
EREG 919 F. Hall Vol #: 7
EREG 920 K. Heller Vol #: 7
2005N-0373 Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
EMC 5 NIST Vol #: 9
2005P-0402 Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic- depressive illness."
PDN 1 FDA/CDER to Arnold & Porter Vol #: 5
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 18319 J. Nored Vol #: 198
C 18320 J. Mitchell Vol #: 198
C 18321 M. DeRow Vol #: 198
EMC 4422 C. Sembower Vol #: 199
EMC 4423 J. Benton Vol #: 199
EMC 4424 J. Feinleib Vol #: 199
EMC 4425 D. Svoboda Vol #: 199
EMC 4426 C. Ware Vol #: 199
EMC 4427 D. Steffins Vol #: 199
EMC 4428 J. Strottman Vol #: 199
EMC 4429 J. Boudreaux Vol #: 199
EMC 4430 L. Riley Vol #: 199
EMC 4431 C. Nash Vol #: 199
EMC 4432 L. Royster Vol #: 199
EMC 4433 J. Neuman Vol #: 199
EMC 4434 V. Vise Vol #: 199
EMC 4435 G. Pullano Vol #: 199
EMC 4436 P. Taylor Vol #: 199
EMC 4437 C. Rape Vol #: 199
EMC 4438 R. Odell Vol #: 199
EMC 4439 F. Shirron Vol #: 199
2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
EMC 1 ASCO Vol #: 3
2006D-0480 Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food D Drug Administration
C 1289 P. Schmitt Vol #: 25
C 1290 K. Davis Vol #: 25
2006P-0201 Cefotan (cefotetan injection), equivalent 1 g base/vial and 2 g base/vial, mfged by AstraZeneca has been voluntarily withdrawn from sale for safety and efficacy reasons
LET 2 FDA/CDER to B. Braum Medical Inc. Vol #: 1
2006P-0379 To urge the FDA's prompt action to cancel the GRAS desgnation for diacetyl
LET 1 FDA/CFSAN to George Washington University Vol #: 2
2006P-0387 Declare That Clobetasol Propionate from, 0.05% is suitable for submission in an ANDA.
RC 1 Paddock Laboratories, Inc. Vol #: 1
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 105 S. Husband Vol #: 6
2006P-0415 Petition Seeking Regulation of Cloned Animals
EMC 214 K. Davis Vol #: 6
2006P-0428 Combivent (ipratropium bromide and albuterol sulfate)
EMC 1 Alpha-1 Foundation Vol #: 1
2006P-0513 Determine that the Reference Listed Drug, Hydrochlorothiazide Tablets USP 100 mg, was voluntarily discontinued from sale in the US for reasons other than safety or effectiveness
LET 1 CDER to Caraco Pharmaceutical Lab., Ltd. Vol #: 1
2006P-0520 Determination for Methotrexate Injection, USP, Preservative Free, Eq. 500 mg base/20 mL, NDA 11-719)
LET 1 FDA/CEDER to SICOR Pharmaceuticals, Inc. Vol #: 1
2006P-0522 Apply Bioequivalence Requirements Consistent with 21 CFR 320.24(b)(4) to any ANDA for a Generic Drug Product using Lidoderm as its RLD
LET 1 FDA/CDER to Endo Pharmaceuticals Vol #: 1
2006P-0523 Require ANDA applicant for generic of Eloxatin solution as reference drug to perform clinical testing
LET 1 FDA/CDER to Sanofi Aventis US LLC Vol #: 4
2006P-0524 Withdrawal of Approval of and recall all available stock of Ziana
LET 2 FDA/CEDER to Center for Dermatology and Laser Vol #: 1
2007D-0089 Guidance for Industry and Review Staff on Target Product Profile A Strategic Development Process Tool
EMC 3 K. Hollister Vol #: 1
2007N-0005 Prescription Drug User Fee Act (PDUFA): Public Meeting
EMC 1 American Heart Association Vol #: 3
EMC 2 Union of Concerned Scientists Vol #: 3
TS 22 ALS Association Vol #: 3
TS 23 National Alliance on Mental Illness (NAMI) Vol #: 3
2007N-0121 Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
EMC 30 P. McCauley Vol #: 2
EMC 31 C. Motlow Vol #: 2
2007N-0123 Amlodipine Abbreviated New Drug Application Approvals
LET 5 FDA/CDER to ANDA Applicant Vol #: 2
2007N-0186 Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
BKG 1 Background Information Vol #: 1
NIR 1 FDA Vol #: 1
2007P-0085 Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
EC 413 Don't Mess With Our Chocolate Vol #: 3
EC 414 Ms. karen pellerano Vol #: 3
EC 415 Ms. Ellen Williams Vol #: 3
EC 416 Ms. donna tomasetti Vol #: 3
EC 417 Don't Mess With Our Chocolate Vol #: 3
EC 418 Don't Mess With Our Chocolate Vol #: 3
EC 419 Mrs. Amy Miller Vol #: 3
EC 420 Miss. Sharon R. Bryant Vol #: 3
EC 421 Ms. Diane Lamb Vol #: 3
EC 422 Ms. kathleen Kendricks Vol #: 3
EC 423 Miss. Theresa Riccardelli Vol #: 3
EC 424 Ms. Katie Hunter Vol #: 3
EC 425 Mrs. Georgenna Biser Vol #: 3
EC 426 Don't Mess With Our Chocolate Vol #: 3
EC 427 Don't Mess With Our Chocolate Vol #: 3
EC 428 Joby Vol #: 3
EC 429 St. Agnes Boys H.S. Vol #: 3
EC 430 Don't mess with our chocolate Vol #: 3
EC 431 Ms. Myrena Seda Vol #: 3
EC 432 knipschildt chocolatier Vol #: 3
EC 433 Mrs. Beatrice Castillo Vol #: 3
EC 434 Don't Mess With Our Chocolate Vol #: 3
EC 435 Dr. Dane Adkinson Vol #: 3
EC 436 Ms. Patsy Shivers Vol #: 3
EC 437 Don't Mess With Our Chocolate Vol #: 3
EC 438 Ms. Suzanne Hammer Vol #: 3
EC 439 Mrs. Brenda Snow Vol #: 3
EC 440 Ms. Krista Wiltbank Vol #: 3
EC 441 Connelly/Zamora Family Vol #: 3
EC 442 Mrs. Sharon Kahren Vol #: 3
EC 443 Mrs. Marina Kapeleris Vol #: 3
EC 444 DON'T MESS WITH OUR CHOCOLATE Vol #: 3
EC 445 puddletown school Vol #: 3
EC 446 Ms. Mary Gerbode Vol #: 3
EC 447 Mrs. Laurie Simpson Vol #: 3
EC 448 Don't mess with our chocolate! Vol #: 3
EC 449 Miss. Cathy Belk Vol #: 3
EC 450 Ms. Jennifer Gillespie Vol #: 3
EC 451 Ms. LINDA FUENTES Vol #: 3
EC 452 Mr. Angelo Fusco Vol #: 3
EC 453 Ms. Jennifer Moore Myers Vol #: 3
EC 454 Ms. susan kuhn Vol #: 3
EC 455 Miss. Esther Marshall Vol #: 3
EC 456 Mr. Paul Krysiak Vol #: 3
EC 457 Don't Mess WIth Our Chocolate Vol #: 3
EC 458 Mr. Mario Prats Vol #: 3
EC 459 Ms. michele deemer Vol #: 3
EC 460 Ms. christy gray Vol #: 3
EC 461 Dr. Eleanor KING Vol #: 3
EC 462 Miss. Sara Krosschell Vol #: 3
EC 463 Mrs. EUNICE JUDGE Vol #: 3
EC 464 Don't Mess With Our Chocolate Vol #: 3
EC 465 Don't Mess with Our Chocolate Vol #: 3
EC 466 Don't Mess With Our Chocolate Vol #: 3
EC 467 Mrs. Amanda Jakubowski Vol #: 3
EC 468 Mr. Elvin Bruce Vol #: 3
EC 469 na Vol #: 3
EC 470 Don't Mess With Our Chocolate Vol #: 3
EC 471 Don't Mess With Our Chocolate Vol #: 3
EC 472 Mrs. Sandra Sauls Vol #: 3
EC 473 Don't Mess With Our Chocolate Vol #: 3
EC 474 Don't Mess With Our Chocolate Vol #: 3
EC 475 Ms. Ann Marie Kidwell Vol #: 3
EC 476 Mr. Ronald Garduno Vol #: 3
EC 477 Ms. m marlo Vol #: 3
EC 478 Mrs. Maria Petranek Vol #: 3
EC 479 Don't Mess with Our Chocolate Vol #: 3
EC 480 Mrs. Jennifer Peronto Vol #: 3
EC 481 Ms. M.A. Roberts Vol #: 3
EC 482 Mr. Paul Turner Vol #: 3
EC 483 Ms. Patricia Craigmile Vol #: 3
EC 484 Dont mess with our chocolate Vol #: 3
EC 485 Ms. JOANNA SPRINKLES Vol #: 3
EC 486 Don't Mess With Our Chocolate Vol #: 3
EC 487 Mrs. R Brownson Vol #: 3
EC 488 Mrs. Marcella Mathewes Vol #: 3
EC 489 Ms. LINDA SHERMAN Vol #: 3
EC 490 Don't Mess With Our Chocolate Vol #: 3
EC 491 Mr. Shaun Parrish Vol #: 3
EC 492 Mrs. Peggy Schoolfield Vol #: 3
EC 493 Dr. Sarah Arvey Vol #: 3
EC 494 Mr. Dean Paul Vol #: 3
EC 495 Yachana Gourmet Vol #: 3
EC 496 Mrs. Carolyn Belko Vol #: 3
EC 497 Mrs. Carole Fern Vol #: 3
EC 498 Don't Mess With Our Chocolate Vol #: 3
EC 499 Don't Mess With Our Chocolate Vol #: 3
EC 500 Don't Mess With Our Chocolate Vol #: 3
EMC 175 L. Posner Vol #: 4
2007P-0251 Petition for a policy statement requiring that all future advisory committee meetings discussing specific products include an oral scientific presentation by FDA staff on the products reviewed, including a thorough safety and efficacy assessment
ACK 1 FDA/DDM to Public Citizen Health Research Group Vol #: 1
CP 1 Public Citizen Health Research Group Vol #: 1

Page created on June 26, 2007 ue

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