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| Dockets Entered
On July 11, 2007
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| Docket #
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| Title
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| 2005D-0356
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| Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records
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| 2005N-0272
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| Irradiation in the Production, Processing & Handling of Food
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| 2005P-0464
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| Remove metered-dose inhalers (MDI) containing the single active moieties beclomethasone, fluticasone, and salmeterol, respectively, from the essential-use list of ozone-depleting substance
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| 2006D-0108
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| Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs
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| 2006D-0480
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| Guidance for Industry
on Complementary & Alternative Medicine Products & Their Regulation
by the Food and Drug Administration
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| 2006P-0218
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| To permit an abbrevation New Drug Application Triamcinolone Diacetate Suspension
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| 2007D-0083
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| Guidance for Industry and Food and Drug Administration Staff; Modifications to Devices Subject to Premarket Approval (PMA) Applications The PMA Supplement Decision Making Process
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| 2007D-0118
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| Guidance for Industry on the Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
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| 2007D-0173
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| Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators
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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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| 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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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| LET 6
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| FDA
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| Vol #:
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| 580
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| C 1423
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| A. Robinson
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| Vol #:
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| 262
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| C 1424
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| N. de Peyster
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| Vol #:
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| 262
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| C 1425
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| D. Mahoney
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| Vol #:
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| 262
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| EC 525
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| Mrs. Eva Smith-Furgason
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| Vol #:
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| 17
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| EC 25
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| Mr. Duchowski Ryszard
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| Vol #:
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| 2
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| EC 26
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| USANA Health Sciences-Ind. Dist.
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| Vol #:
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| 2
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| 2005D-0356
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| Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records
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| EC 6
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| Mrs. Jeannine Seymour
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| Vol #:
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| 1
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| 2005N-0272
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| Irradiation in the Production, Processing & Handling of Food
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| C 803
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| L. Pfeiffer
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| Vol #:
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| 14
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| C 804
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| T. Wade
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| Vol #:
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| 14
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| C 805
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| J. Davidson
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| Vol #:
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| 14
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| EC 2243
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| Ms. Carol Wyckoff
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| Vol #:
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| 29
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| EC 2244
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| Mr. Paul Pollock
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| Vol #:
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| 29
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| EC 2245
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| Ms. T Fuller
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| Vol #:
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| 29
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| EC 2246
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| Miss. Andrea Eccard
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| Vol #:
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| 29
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| EC 2247
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| Mr. Colin Rumbley
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| Vol #:
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| 29
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| EC 2248
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| Mrs. Roberta Lewis
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| Vol #:
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| 29
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| EC 2249
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| Miss. Jane Greene
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| Vol #:
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| 29
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| EC 2250
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| Mr. Russ Spoto
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| Vol #:
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| 29
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| 2006P-0218
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| To permit an abbrevation New Drug Application Triamcinolone Diacetate Suspension
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| N 1
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| FDA
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| Vol #:
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| 1
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| 2007D-0083
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| Guidance for Industry and Food and Drug Administration Staff; Modifications to Devices Subject to Premarket Approval (PMA) Applications The PMA Supplement Decision Making Process
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| C 4
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| Medtronic
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| Vol #:
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| 1
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| 2007D-0118
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| Guidance for Industry on the Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
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| C 1
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| Wyeth Pharmaceuticals
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| Vol #:
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| 1
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| 2007D-0173
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| Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators
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| C 2
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| Consortium of Independent Reveiw Boards (CIRB)
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| Vol #:
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| 1
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| C 3
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| R. Reinhard
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| Vol #:
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| 1
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| C 4
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| Boehringer Ingelheim Pharmaceuticals, Inc.
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| Vol #:
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| 1
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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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| C 2
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| Lake Erie College of Osteopathic Medicine (LECOM)
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| Vol #:
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| 7
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| C 3
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| Institute for Safe Medication Practices
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| Vol #:
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| 7
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| M 1
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| Jeffrey Shuren, Assistant Commissioner for Policy
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| Vol #:
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| 1
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| TS 1
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| Cynthia R. Pfeffer, M.D.
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| Vol #:
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| 8
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| TS 2
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| Nancy M. Allen-LaPointe, Pharm.D.
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| Vol #:
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| 8
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| TS 3
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| Ruth S. Day
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| Vol #:
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| 8
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| TS 4
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| Michael S. Wolf, MA, MPH, PHD
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| Vol #:
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| 8
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| TS 5
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| Dr. Vera Sharav, President
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| Vol #:
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| 8
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| TS 6
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| John M. Coster, PhD, R.Ph
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| Vol #:
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| 8
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| TS 7
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| Marissa Craddock
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| Vol #:
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| 8
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| TS 8
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| Steven Heidenthal, R.Ph.
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| Vol #:
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| 8
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| TS 9
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| Paul Johnson, R.Ph
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| Vol #:
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| 8
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| TS 10
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| Kala L. Paul, M.D.
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| Vol #:
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| 8
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| TS 11
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| Gerald K. McEvoy, Pharm.D.
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| Vol #:
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| 8
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