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| Dockets Entered
On January 2, 2008
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| Docket #
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| Title
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| 1980N-0280
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| Vaginal Contraceptive Drug Products for OTC Use
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| 1994D-0025
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| Guidelines on the Voluntary Labeling Milk & Milk Products from Cows That Have Not Been Treated with rbSt or rbGH
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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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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| 2007D-0396
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| Drug-Induced Liver Injury: Premarketing Clinical Evaluation;Draft Guidance
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| 2007D-0491
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| Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
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| 2007D-0492
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| Guidance for Industry and Food and Drug Administration; Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
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| 2007D-0496
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| Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonpresc
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| 2007N-0343
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| Electronic Nonclinical Study Data Submission; Notice of Pilot Project
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| 2007N-0412
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| Adolescent Over-the-Counter Drug Product Use
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| 2007N-0480
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| Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Products Marketed Life Cycle; Public Workshop
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| 2007P-0273
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| Request that CDER update the official drug labels for penicillin G potassium and penicillin Gsodium for injection
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| 2008P-0001
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| Determine that an abbreviated new drug application is suitable for a non-aerosol oral spray anesthetic delivering 10 mg lidocaine per metered dose.
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| 1980N-0280
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| Vaginal Contraceptive Drug Products for OTC Use
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| REF 1
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| Reference (Executive Order 12866)
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| 1
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| 1994D-0025
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| Guidelines on the Voluntary Labeling Milk & Milk Products from Cows That Have Not Been Treated with rbSt or rbGH
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| ANS 7
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| United States Senate & FDA-Associate Commissioner for Legislative Affairs
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| Vol #:
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| 58
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| ANS 8
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| FDA/Office of Consumer Affairs to Ron D. Cox
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| Vol #:
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| 60
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| ANS 9
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| FDA/Deputy Associate Commissioner for Legislative Affairs to United States Senate
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| Vol #:
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| 60
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| ANS 10
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| FDA/Deputy Associate Commissioner for Legislative Affairs to United States Senate
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| Vol #:
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| 60
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| ACK 1
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| FDA/DDM to Carolyn Smith
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| Vol #:
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| 35
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| CP 1
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| Carolyn Smith
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| Vol #:
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| 35
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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 520
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| Charlene Powell
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| Vol #:
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| 14
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| C 521
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| Charlene Powell
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| Vol #:
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| 14
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| 2007D-0396
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| Drug-Induced Liver Injury: Premarketing Clinical Evaluation;Draft Guidance
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| C 7
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| sanofi aventis
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| Vol #:
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| 1
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| C 8
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| Pfizer
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| Vol #:
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| 1
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| 2007D-0491
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| Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
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| GDL 1
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| Guidance
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| Vol #:
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| 1
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| NAD 1
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| FDA
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| Vol #:
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| 1
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| 2007D-0492
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| Guidance for Industry and Food and Drug Administration; Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
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| GDL 1
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| Guidance
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| Vol #:
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| 1
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| NAD 1
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| FDA
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| Vol #:
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| 1
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| 2007D-0496
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| Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonpresc
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| GDL 1
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| Guidance
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| Vol #:
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| 1
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| NAD 1
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| FDA
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| Vol #:
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| 1
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| 2007N-0343
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| Electronic Nonclinical Study Data Submission; Notice of Pilot Project
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| LET 5
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| AstraZeneca
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| Vol #:
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| 1
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| 2007N-0412
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| Adolescent Over-the-Counter Drug Product Use
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| LST 2
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| FDA
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| Vol #:
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| 1
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| LST 3
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| FDA
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| Vol #:
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| 1
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| LST 4
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| FDA
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| Vol #:
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| 1
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| 2007N-0480
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| Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Products Marketed Life Cycle; Public Workshop
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| C 1
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| B. Sachau
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| Vol #:
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| 1
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| 2007P-0273
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| Request that CDER update the official drug labels for penicillin G potassium and penicillin Gsodium for injection
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| LET 1
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| Jane A. Axelrad
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| Vol #:
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| 3
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| 2008P-0001
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| Determine that an abbreviated new drug application is suitable for a non-aerosol oral spray anesthetic delivering 10 mg lidocaine per metered dose.
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| ACK 1
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| FDA/DDM to Odan Laboratories, Inc.
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| Vol #:
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| 1
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| CP 1
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| Odan Laboratories, Inc.
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| Vol #:
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| 1
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