| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On May 2, 2006
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1975N-0183H
|
| Health-Care Antiseptic Drug Products for OTC Human Use
|
|
|
|
|
| 1995S-0316
|
| 75-Day Premarket Notifications for New Dietary Ingredients
|
|
|
|
|
| 1998P-0724
|
| Prohibition of Cochineal Extract and Carmine Color Additives
|
|
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
|
|
| 2000D-1632
|
| Management of Adverse Event Reports (AER's) (VICH GL24)
|
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
|
|
| 2002P-0435
|
| Effective Approval of Alphanate Antihemophilic Factor
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| 2003N-0273
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Research Study Complaint Form
|
|
|
|
|
| 2004E-0039
|
| Patent Extension for CRESTOR (rosuvastatin), U.S. Patent No. RE37,314
|
|
|
|
|
| 2005D-0011
|
| Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products
|
|
|
|
|
| 2005D-0401
|
| 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
|
|
|
|
|
|
|
|
|
| 2005N-0285
|
| Current Good Manufacturing Practice Regulation and Investigational New Drugs
|
|
|
|
|
| 2005P-0121
|
| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| 2005P-0456
|
| Determine that the discontinued formulation Zosyn (piperacillin and tazobactam for injection), was not discontinued for safety and efficacy reasons
|
|
|
|
|
| 2006D-0066
|
| Guidance for Industry and FDA Staff: Whole Grains Label Statements
|
|
|
|
|
| 2006D-0138
|
| Guidance for Industry: Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims
|
|
|
|
|
| 2006D-0169
|
| 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
|
|
|
|
|
| 2006D-0170
|
| International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal
|
|
|
|
|
|
|
|
|
| 2006F-0059
|
| Safe Use of Polydextrose as a Bulking Agent, Formulation Aid, Humectant and Texturizer in All Foods, except Meat and Poultry (FAP 6A4763)
|
|
|
|
|
| 2006N-0166
|
| Agency Emergency Processing Under OMB Review; MedWatch - The FDA Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners organizations
|
|
|
|
|
| 2006P-0072
|
| ANDA for prednisolone sodium phosophate, USP,oral solution, 10 mg prednisolone base/5mL.
|
|
|
|
|
| 2006P-0098
|
| 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
|
|
|
|
|
|
| 2006P-0123
|
| Request that all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products
|
|
|
|
|
| 2006P-0124
|
| Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
|
|
|
|
|
| 2006P-0179
|
| Ban of Carcinogenic Potassium Bromate
|
|
|
|
|
| 1975N-0183H
|
| Health-Care Antiseptic Drug Products for OTC Human Use
|
|
|
|
|
| ANS 5
|
| FDA/CDER/ONP to Ciba Specilaty Chemicals
|
| Vol #:
|
| 200
|
|
|
|
|
| 1995S-0316
|
| 75-Day Premarket Notifications for New Dietary Ingredients
|
|
|
|
|
| RPT 323
|
| Shenzhen Qianrenren Sci. & Tech. Development Co. Ltd.
|
| Vol #:
|
| 255
|
|
|
|
|
| RPT 324
|
| B A U Inc
|
| Vol #:
|
| 256
|
|
|
|
|
| RPT 325
|
| Stragen Pharma SA
|
| Vol #:
|
| 257
|
|
| | | | | | | | |
|
| |
|
| 1998P-0724
|
| Prohibition of Cochineal Extract and Carmine Color Additives
|
|
|
|
|
| EMC 24
|
| Food Products Association (FPA)
|
| Vol #:
|
| 3
|
|
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
|
|
| EMC 641
|
| M. Meade
|
| Vol #:
|
| 24
|
|
|
|
|
| 2000D-1632
|
| Management of Adverse Event Reports (AER's) (VICH GL24)
|
|
|
|
|
| GDL 2
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
|
|
| EMC 639
|
| Mission Possible International
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 640
|
| Calorie Control Council
|
| Vol #:
|
| 9
|
|
|
|
|
| 2002P-0435
|
| Effective Approval of Alphanate Antihemophilic Factor
|
|
|
|
|
| WDL 1
|
| ZLB Behring
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| EMC 1285
|
| J. Daline
|
| Vol #:
|
| 12
|
|
|
|
|
| EMC 1286
|
| S. Pelletier
|
| Vol #:
|
| 12
|
|
|
|
|
| 2003N-0273
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Research Study Complaint Form
|
|
|
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| SS 1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004E-0039
|
| Patent Extension for CRESTOR (rosuvastatin), U.S. Patent No. RE37,314
|
|
|
|
|
| C 1
|
| D. Lowe
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0011
|
| Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products
|
|
|
|
|
| EMC 7
|
| Biotechnology Industry Organization (BIO)
|
| Vol #:
|
| 2
|
|
|
|
|
| 2005D-0401
|
| 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
|
|
|
|
|
|
|
|
|
| GDL 2
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0285
|
| Current Good Manufacturing Practice Regulation and Investigational New Drugs
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0121
|
| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
|
|
|
|
|
| RC 1
|
| RS Medical
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| C 7912
|
| O. L. Mesier
|
| Vol #:
|
| 118
|
|
|
|
|
| C 7913
|
| B. C. Mosier
|
| Vol #:
|
| 118
|
|
|
|
|
| C 7914
|
| P. Nankivel
|
| Vol #:
|
| 118
|
|
|
|
|
| C 7915
|
| R. Binn-Hersh
|
| Vol #:
|
| 118
|
|
|
|
|
| C 7916
|
| C. Reed
|
| Vol #:
|
| 118
|
|
|
|
|
| C 7917
|
| K. Ruddek
|
| Vol #:
|
| 118
|
|
|
|
|
| C 7918
|
| D. Richards
|
| Vol #:
|
| 118
|
|
|
|
|
| C 7919
|
| J. L. Presetter
|
| Vol #:
|
| 118
|
|
|
|
|
| C 7920
|
| D. Creel
|
| Vol #:
|
| 118
|
|
|
|
|
| C 7921
|
| A. Watkins
|
| Vol #:
|
| 118
|
|
|
|
|
| 2005P-0456
|
| Determine that the discontinued formulation Zosyn (piperacillin and tazobactam for injection), was not discontinued for safety and efficacy reasons
|
|
|
|
|
| C 3
|
| D. Lowe
|
| Vol #:
|
| 2
|
|
|
|
|
| 2006D-0066
|
| Guidance for Industry and FDA Staff: Whole Grains Label Statements
|
|
|
|
|
| C 22
|
| Flax Canada 2015
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0138
|
| Guidance for Industry: Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims
|
|
|
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0169
|
| 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
|
|
|
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0170
|
| International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal
|
|
|
|
|
|
|
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006F-0059
|
| Safe Use of Polydextrose as a Bulking Agent, Formulation Aid, Humectant and Texturizer in All Foods, except Meat and Poultry (FAP 6A4763)
|
|
|
|
|
| BKG 1
|
| Tabs A-B
|
| Vol #:
|
| 1
|
|
|
|
|
| NFL 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0166
|
| Agency Emergency Processing Under OMB Review; MedWatch - The FDA Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners organizations
|
|
|
|
|
|
|
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0072
|
| ANDA for prednisolone sodium phosophate, USP,oral solution, 10 mg prednisolone base/5mL.
|
|
|
|
|
| C 2
|
| D. Lowe
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0098
|
| 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
|
|
