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| Dockets Entered
On May 2, 2006
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| Docket #
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| Title
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| 1975N-0183H
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| Health-Care Antiseptic Drug Products for OTC Human Use
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2000D-1632
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| Management of Adverse Event Reports (AER's) (VICH GL24)
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2002P-0435
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| Effective Approval of Alphanate Antihemophilic Factor
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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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| 2003N-0273
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Research Study Complaint Form
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| 2004E-0039
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| Patent Extension for CRESTOR (rosuvastatin), U.S. Patent No. RE37,314
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| 2005D-0011
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| Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products
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| 2005D-0401
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| Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended Prominent and Conspicuous Mark of Manufacturers on Single-Us
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| 2005N-0285
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| Current Good Manufacturing Practice Regulation and Investigational New Drugs
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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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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| 2005P-0456
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| Determine that the discontinued formulation Zosyn (piperacillin and tazobactam for injection), was not discontinued for safety and efficacy reasons
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| 2006D-0066
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| Guidance for Industry and FDA Staff: Whole Grains Label Statements
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| 2006D-0138
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| Guidance for Industry: Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims
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| 2006D-0169
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| Guidance for Industry: Guidance on the labeling of Certain Uses of Lecithin Derived from Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act; Availability
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| 2006D-0170
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| International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal
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| 2006F-0059
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| Safe Use of Polydextrose as a Bulking Agent, Formulation Aid, Humectant and Texturizer in All Foods, except Meat and Poultry (FAP 6A4763)
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| 2006N-0166
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| Agency Emergency Processing Under OMB Review; MedWatch - The FDA Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners organizations
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| 2006P-0072
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| ANDA for prednisolone sodium phosophate, USP,oral solution, 10 mg prednisolone base/5mL.
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| 2006P-0098
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| Seeks a determination that Loperamide hydrochloride 2 mg orally dissolving film strip is suitable for an ANDA based on the reference listed drug loperamide hydrochloride 2 mg oral chewable tablet (Imo
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| 2006P-0123
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| Request that all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products
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| 2006P-0124
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| Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
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| 2006P-0179
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| Ban of Carcinogenic Potassium Bromate
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| 1975N-0183H
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| Health-Care Antiseptic Drug Products for OTC Human Use
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| ANS 5
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| FDA/CDER/ONP to Ciba Specilaty Chemicals
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| Vol #:
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| 200
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT 323
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| Shenzhen Qianrenren Sci. & Tech. Development Co. Ltd.
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| Vol #:
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| 255
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| RPT 324
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| B A U Inc
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| Vol #:
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| 256
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| RPT 325
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| Stragen Pharma SA
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| Vol #:
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| 257
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| EMC 24
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| Food Products Association (FPA)
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| Vol #:
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| 3
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 641
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| M. Meade
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| Vol #:
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| 24
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| 2000D-1632
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| Management of Adverse Event Reports (AER's) (VICH GL24)
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| GDL 2
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| Guidance
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| Vol #:
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| 1
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| NAD 2
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| FDA
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| Vol #:
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| 1
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 639
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| Mission Possible International
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| Vol #:
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| 9
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| EMC 640
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| Calorie Control Council
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| Vol #:
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| 9
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| 2002P-0435
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| Effective Approval of Alphanate Antihemophilic Factor
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| WDL 1
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| ZLB Behring
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| Vol #:
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| 1
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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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| EMC 1285
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| J. Daline
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| Vol #:
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| 12
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| EMC 1286
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| S. Pelletier
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| Vol #:
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| 12
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| 2003N-0273
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Research Study Complaint Form
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| NAL 1
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| FDA
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| Vol #:
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| 1
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| SS 1
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| Supporting Statement
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| Vol #:
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| 1
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| 2004E-0039
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| Patent Extension for CRESTOR (rosuvastatin), U.S. Patent No. RE37,314
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2005D-0011
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| Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products
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| EMC 7
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| Biotechnology Industry Organization (BIO)
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| Vol #:
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| 2
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| 2005D-0401
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| Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended Prominent and Conspicuous Mark of Manufacturers on Single-Us
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| GDL 2
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| Guidance
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| Vol #:
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| 1
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| NAD 2
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| FDA
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| Vol #:
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| 1
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| 2005N-0285
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| Current Good Manufacturing Practice Regulation and Investigational New Drugs
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| RC 1
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| RS Medical
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| Vol #:
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| 1
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| C 7912
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| O. L. Mesier
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| Vol #:
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| 118
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| C 7913
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| B. C. Mosier
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| Vol #:
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| 118
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| C 7914
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| P. Nankivel
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| Vol #:
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| 118
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| C 7915
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| R. Binn-Hersh
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| Vol #:
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| 118
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| C 7916
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| C. Reed
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| Vol #:
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| 118
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| C 7917
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| K. Ruddek
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| Vol #:
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| 118
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| C 7918
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| D. Richards
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| Vol #:
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| 118
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| C 7919
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| J. L. Presetter
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| Vol #:
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| 118
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| C 7920
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| D. Creel
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| Vol #:
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| 118
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| C 7921
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| A. Watkins
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| Vol #:
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| 118
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| 2005P-0456
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| Determine that the discontinued formulation Zosyn (piperacillin and tazobactam for injection), was not discontinued for safety and efficacy reasons
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| C 3
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| D. Lowe
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| Vol #:
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| 2
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| 2006D-0066
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| Guidance for Industry and FDA Staff: Whole Grains Label Statements
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| C 22
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| Flax Canada 2015
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| Vol #:
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| 1
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| 2006D-0138
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| Guidance for Industry: Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims
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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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| 2006D-0169
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| Guidance for Industry: Guidance on the labeling of Certain Uses of Lecithin Derived from Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act; Availability
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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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| 2006D-0170
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| International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal
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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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| 2006F-0059
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| Safe Use of Polydextrose as a Bulking Agent, Formulation Aid, Humectant and Texturizer in All Foods, except Meat and Poultry (FAP 6A4763)
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| BKG 1
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| Tabs A-B
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| Vol #:
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| 1
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| NFL 2
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| FDA
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| Vol #:
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| 1
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| 2006N-0166
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| Agency Emergency Processing Under OMB Review; MedWatch - The FDA Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners organizations
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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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| 2006P-0072
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| ANDA for prednisolone sodium phosophate, USP,oral solution, 10 mg prednisolone base/5mL.
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| C 2
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0098
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| Seeks a determination that Loperamide hydrochloride 2 mg orally dissolving film strip is suitable for an ANDA based on the reference listed drug loperamide hydrochloride 2 mg oral
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