| | | | | | | | | | |
|
| |
|
| Dockets Entered
On February 15, 2006
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 2000D-1400
|
| Reproductive Toxicity Studies preventive vaccines Disease
|
|
|
|
|
| 2003E-0407
|
| Patent Term Restoration Application for Cypher, U.S. Patent No. 5,563,146
|
|
|
|
|
| 2004D-0369
|
| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
|
|
|
|
|
| 2004E-0389
|
| Patent Extension for SURPASS (diclofenac sodium), U.S. Patent No. 4,937,078
|
|
|
|
|
| 2005N-0296
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators
|
|
|
|
|
| 2005N-0425
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
|
|
|
|
|
|
|
|
|
| 2005P-0023
|
| Determine if Tequin Injection 10mg/ml (200mg)- 20 mL was withdrawn for safety or effectiveness reasons
|
|
|
|
|
| 2005P-0104
|
| Determine whether Peptavlon (pentagastrin) was voluntarily withdrawn from sale for reasons other than safety or effectiveness
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| 2005P-0418
|
| Dextroamphetamine sulfate tablets, 2.5 mg,7.5 mg,15 mg,20 mg, and 30 mg suitable for submission as an ANDA
|
|
|
|
|
| 2006D-0017
|
| Human Subject Protection--Information for Institutional Review Boards, Clinical Investigators, and Sponsors; Rescission, Reissuance, and Development of FDA Guidance Documents
|
|
|
|
|
| 2006D-0044
|
| Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
|
|
|
|
|
| 2006N-0065
|
| Emerging Clostridial Disease; Public Workshop
|
|
|
|
|
| 2006P-0069
|
| Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
|
|
|
|
|
| 2006V-0076
|
| Laser Light Show
|
|
|
|
|
| 2000D-1400
|
| Reproductive Toxicity Studies preventive vaccines Disease
|
|
|
|
|
| BKG
1
|
| Backgroung Material
|
| Vol #:
|
| 2
|
|
|
|
|
| GDL
2
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003E-0407
|
| Patent Term Restoration Application for Cypher, U.S. Patent No. 5,563,146
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0369
|
| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 15
|
|
| |
|
| 2004E-0389
|
| Patent Extension for SURPASS (diclofenac sodium), U.S. Patent No. 4,937,078
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0296
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators
|
|
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0425
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
|
|
|
|
|
|
|
|
| |
|
| NSA
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2005P-0023
|
| Determine if Tequin Injection 10mg/ml (200mg)- 20 mL was withdrawn for safety or effectiveness reasons
|
|
| | | | | | | | |
|
| |
|
| EC
2519
|
| Dr. michael eurs
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
2520
|
| Ms. MaryAnn Gamel
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
2521
|
| Ms. Glenda Hillyer
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
2522
|
| Westlake Natural Health
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
2523
|
| Mrs. Charlotte Nakosteen
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
2524
|
| Ms. Candace Wingo
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
2525
|
| Mrs. Sharon Scully
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
2526
|
| Ms. Karen Hamburg
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
2527
|
| Ms. Cindy Bader
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
2528
|
| Ms. Lucia Hodges
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
2529
|
| Dr. Javier Diaz-Blanco
|
| Vol #:
|
| 9
|
|
| |
|
| 2005P-0418
|
| Dextroamphetamine sulfate tablets, 2.5 mg,7.5 mg,15 mg,20 mg, and 30 mg suitable for submission as an ANDA
|
|
|
|
|
| C 1
|
| D. Lowe
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0017
|
| Human Subject Protection--Information for Institutional Review Boards, Clinical Investigators, and Sponsors; Rescission, Reissuance, and Development of FDA Guidance Documents
|
|
|
|
|
| GDL
1
|
| Information Sheet Guidance For IRBs,Clinical Investigators, and Sponsors
|
| Vol #:
|
| 1
|
|
|
|
|
| GDL
2
|
| FDA Institutional Review Board Inspections
|
| Vol #:
|
| 1
|
|
|
|
|
| GDL
3
|
| Waiver of IRB Requirements for Drug and Biological Products Stuides
|
| Vol #:
|
| 1
|
|
|
|
|
| GDL
4
|
| Significant Risk and Nonsignificant Risk Medical Device Studies
|
| Vol #:
|
| 1
|
|
|
|
|
| GDL
5
|
| Frequently Asked Questions About Medical Devices
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2006D-0044
|
| Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
|
|
|
|
|
| GDL
1
|
| GUIDANCE
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0065
|
| Emerging Clostridial Disease; Public Workshop
|
|
|
|
|
| NM
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0069
|
| Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
|
|
|
|
|
| CP
1
|
| The quaker Oats Company
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006V-0076
|
| Laser Light Show
|
|
|
|
|
| ACK
1
|
| HFA-305 to Renishaw plc
|
| Vol #:
|
| 1
|
|
|
|
|
| VAR
1
|
| Renishaw
|
| Vol #:
|
| 1
|
|
|
|
|
| VAR 2
|
| Number not Used
|
| Vol #:
|
| 1
|
|
