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| Dockets Entered
On June 25, 2007
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| Docket #
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| Title
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| 1999D-1651
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| Chemistry,Mfging/Control Changes to an approved NADA/ANADA
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2005N-0272
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| Irradiation in the Production, Processing & Handling of Food
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| 2005N-0373
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| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
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| 2005P-0402
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| 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."
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| 2006D-0480
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| Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food D Drug Administration
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| 2006P-0201
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| 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
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| 2006P-0379
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| To urge the FDA's prompt action to cancel the GRAS desgnation for diacetyl
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| 2006P-0387
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| Declare That Clobetasol Propionate from, 0.05% is suitable for submission in an ANDA.
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| 2006P-0428
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| Combivent (ipratropium bromide and albuterol sulfate)
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| 2006P-0513
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| 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
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| 2006P-0520
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| Determination for Methotrexate Injection, USP, Preservative Free, Eq. 500 mg base/20 mL, NDA 11-719)
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| 2006P-0522
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| Apply Bioequivalence Requirements Consistent with 21 CFR 320.24(b)(4) to any ANDA for a Generic Drug Product using Lidoderm as its RLD
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| 2006P-0523
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| Require ANDA applicant for generic of Eloxatin solution as reference drug to perform clinical testing
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| 2006P-0524
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| Withdrawal of Approval of and recall all available stock of Ziana
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| 2007D-0089
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| Guidance for Industry and Review Staff on Target Product Profile A Strategic Development Process Tool
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| 2007N-0005
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| Prescription Drug User Fee Act (PDUFA): Public Meeting
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| 2007N-0123
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| Amlodipine Abbreviated New Drug Application Approvals
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| 2007N-0186
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| 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
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| 2007P-0251
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| 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
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| 1999D-1651
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| Chemistry,Mfging/Control Changes to an approved NADA/ANADA
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| EMC 1
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| B. Sachau
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| Vol #:
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| 1
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| EMC 812
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| B. Bowman
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| Vol #:
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| 33
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 4438
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| R. Odell
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| Vol #:
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| 199
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| EMC 4439
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| F. Shirron
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| Vol #:
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| 199
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| EMC 1
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| ASCO
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| Vol #:
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| 3
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| 2006D-0480
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| Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food D Drug Administration
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| C 1289
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| P. Schmitt
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| Vol #:
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| 25
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| C 1290
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| K. Davis
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| Vol #:
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| 25
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| 2006P-0201
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| 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
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| LET 2
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| FDA/CDER to B. Braum Medical Inc.
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| 1
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| 2006P-0379
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| To urge the FDA's prompt action to cancel the GRAS desgnation for diacetyl
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| LET 1
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| FDA/CFSAN to George Washington University
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| Vol #:
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| 2
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| 2006P-0387
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| Declare That Clobetasol Propionate from, 0.05% is suitable for submission in an ANDA.
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| RC 1
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| Paddock Laboratories, Inc.
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| 1
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| C 105
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| S. Husband
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| 6
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| EMC 214
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| K. Davis
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| Vol #:
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| 6
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| 2006P-0428
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| Combivent (ipratropium bromide and albuterol sulfate)
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| EMC 1
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| Alpha-1 Foundation
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| 1
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| 2006P-0513
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| 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
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| LET 1
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| CDER to Caraco Pharmaceutical Lab., Ltd.
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| Vol #:
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| 1
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| 2006P-0520
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| Determination for Methotrexate Injection, USP, Preservative Free, Eq. 500 mg base/20 mL, NDA 11-719)
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| LET 1
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| FDA/CEDER to SICOR Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2006P-0522
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| Apply Bioequivalence Requirements Consistent with 21 CFR 320.24(b)(4) to any ANDA for a Generic Drug Product using Lidoderm as its RLD
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| LET 1
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| FDA/CDER to Endo Pharmaceuticals
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| Vol #:
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| 1
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| 2006P-0523
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| Require ANDA applicant for generic of Eloxatin solution as reference drug to perform clinical testing
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| LET 1
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| FDA/CDER to Sanofi Aventis US LLC
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| Vol #:
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| 4
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| 2006P-0524
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| Withdrawal of Approval of and recall all available stock of Ziana
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| LET 2
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| FDA/CEDER to Center for Dermatology and Laser
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| Vol #:
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| 1
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| 2007D-0089
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| Guidance for Industry and Review Staff on Target Product Profile A Strategic Development Process Tool
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| EMC 3
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| K. Hollister
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| Vol #:
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| 1
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| 2007N-0005
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| Prescription Drug User Fee Act (PDUFA): Public Meeting
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| EMC 1
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| American Heart Association
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| 3
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| EMC 2
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| Union of Concerned Scientists
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| Vol #:
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| 3
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| TS 22
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| ALS Association
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| Vol #:
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| 3
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| TS 23
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| National Alliance on Mental Illness (NAMI)
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| Vol #:
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| 3
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| EMC 30
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| P. McCauley
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| Vol #:
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| 2
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| EMC 31
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| C. Motlow
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| Vol #:
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| 2
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| 2007N-0123
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| Amlodipine Abbreviated New Drug Application Approvals
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| LET 5
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| FDA/CDER to ANDA Applicant
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| 2
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| 2007N-0186
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| 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
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| BKG 1
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| Background Information
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| 1
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| NIR 1
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| FDA
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| Vol #:
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| 1
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| EC 413
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| Don't Mess With Our Chocolate
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| Vol #:
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| 3
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| EC 414
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| Ms. karen pellerano
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| Vol #:
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| 3
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| EC 415
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| Ms. Ellen Williams
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| Vol #:
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| 3
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| EC 416
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| Ms. donna tomasetti
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| Vol #:
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| 3
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| EC 417
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| Don't Mess With Our Chocolate
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| Vol #:
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| 3
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| EC 418
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| Don't Mess With Our Chocolate
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| Vol #:
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| 3
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| EC 419
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| Mrs. Amy Miller
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| Vol #:
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| 3
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| EC 420
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| Miss. Sharon R. Bryant
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| Vol #:
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| 3
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| EC 421
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| Ms. Diane Lamb
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| Vol #:
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| 3
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| EC 422
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| Ms. kathleen Kendricks
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| Vol #:
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| 3
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| EC 423
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| Miss. Theresa Riccardelli
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| Vol #:
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| 3
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| EC 424
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| Ms. Katie Hunter
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| Vol #:
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| 3
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| EC 425
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| Mrs. Georgenna Biser
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| Vol #:
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| 3
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| EC 426
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| Don't Mess With Our Chocolate
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| Vol #:
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| 3
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| EC 427
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| Don't Mess With Our Chocolate
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| Vol #:
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| 3
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| EC 428
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| Joby
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| Vol #:
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| 3
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| EC 429
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| St. Agnes Boys H.S.
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| Vol #:
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| 3
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| EC 467
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| Mrs. Amanda Jakubowski
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| Vol #:
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| 3
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| EC 468
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| Mr. Elvin Bruce
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| Vol #:
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| 3
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| EC 469
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| na
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| Vol #:
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| 3
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| EC 470
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| Don't Mess With Our Chocolate
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| Vol #:
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| 3
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| EC 471
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| Don't Mess With Our Chocolate
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| Vol #:
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| 3
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| EC 472
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| Mrs. Sandra Sauls
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| Vol #:
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| 3
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| EC 473
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| Don't Mess With Our Chocolate
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| Vol #:
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| 3
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| EC 474
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| Don't Mess With Our Chocolate
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| Vol #:
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| 3
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| EC 475
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| Ms. Ann Marie Kidwell
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| Vol #:
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| 3
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| EC 476
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| Mr. Ronald Garduno
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| Vol #:
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| 3
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| EC 477
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| Ms. m marlo
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| Vol #:
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| 3
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| EC 478
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| Mrs. Maria Petranek
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| Vol #:
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| 3
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| EC 479
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| Don't Mess with Our Chocolate
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| Vol #:
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| 3
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| EC 480
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| Mrs. Jennifer Peronto
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| Vol #:
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| 3
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| EC 481
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| Ms. M.A. Roberts
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| Vol #:
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| 3
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| EC 482
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| Mr. Paul Turner
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| Vol #:
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| 3
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| EC 483
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| Ms. Patricia Craigmile
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| Vol #:
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| 3
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| EC 484
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| Dont mess with our chocolate
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| Vol #:
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| 3
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| EC 485
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| Ms. JOANNA SPRINKLES
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| Vol #:
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| 3
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| EC 486
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| Don't Mess With Our Chocolate
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| Vol #:
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| 3
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| EC 487
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| Mrs. R Brownson
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| Vol #:
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| 3
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| EC 488
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| Mrs. Marcella Mathewes
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| Vol #:
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| 3
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| EC 489
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| Ms. LINDA SHERMAN
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| Vol #:
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| 3
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| EC 490
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| Don't Mess With Our Chocolate
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| Vol #:
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| 3
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| EC 491
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| Mr. Shaun Parrish
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| Vol #:
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| 3
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| EC 492
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| Mrs. Peggy Schoolfield
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| Vol #:
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| 3
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| EC 493
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| Dr. Sarah Arvey
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| Vol #:
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| 3
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| EC 494
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| Mr. Dean Paul
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| Vol #:
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| 3
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| EC 495
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| Yachana Gourmet
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| Vol #:
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| 3
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| EC 496
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| Mrs. Carolyn Belko
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| Vol #:
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| 3
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| EC 497
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| Mrs. Carole Fern
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| Vol #:
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| 3
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| EC 498
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| Don't Mess With Our Chocolate
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| Vol #:
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| 3
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| EC 499
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| Don't Mess With Our Chocolate
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| Vol #:
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| 3
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| EC 500
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| Don't Mess With Our Chocolate
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| Vol #:
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| 3
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| EMC 175
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| L. Posner
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| Vol #:
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| 4
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| 2007P-0251
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| 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
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