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| Dockets Entered
On June 5, 2006
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2000D-1400
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| Reproductive Toxicity Studies preventive vaccines Disease
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| 2000D-1632
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| Management of Adverse Event Reports (AER's) (VICH GL24)
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| 2005D-0183
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| Guidance for Industry on Antiviral Drug Development Conducting Virology Studies and Submitting the Data to the Agency
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| 2005N-0347
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| Biological Products for Treatment of Rare Plasma Protein Disorders
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| 2005N-0467
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| Medical Devices; Radiology Devices; Reclassification of Bone Sonometers
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| 2005P-0070
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| ANDA Suitability for Oral Salmon Calcitonin
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| 2005P-0095
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| ANDA 505(b)(2) application for any generic version or other pharmaceutical alternative of Venofer(Iron sucrose injection USP
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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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| 2006D-0083
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| Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines
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| 2006D-0088
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| Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
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| 2006D-0150
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| Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and Food and Drug Administration: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Sp
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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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| 2006D-0191
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| Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
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| 2006N-0104
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| 2006N-0180
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experience with Approved New Animal Drugs
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| 2006P-0092
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| Determine that Astra Zeneca's Diprivan,Teva Sicor's Propofol Injectable Emulsion, and Bedford Laboratories Propofol Injectable Emulsion are misbranded
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| 2006P-0095
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| ANDA suitability for a Piperacillin and Tazobactam for Injection, 13.5 g pharmacy bulk vial
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| 2006Q-0091
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| Qualified Health Claim (QHC): Unsaturated Fatty Acids from Canola Oil and Reduced Risk of Coronary Heart Disease
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 17778
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| NOW Foods
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| Vol #:
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| 164
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| LET 17779
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| NOW Foods
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| Vol #:
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| 164
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| LET 17780
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| NOW Foods
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| Vol #:
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| 164
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| LET 17781
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| NOW Foods
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| Vol #:
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| 164
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| LET 17782
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| NOW Foods
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| Vol #:
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| 164
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| LET 17783
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| NOW Foods
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| Vol #:
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| 163
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| LET 17784
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| NOW Foods
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| Vol #:
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| 164
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| LET 17785
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| NOW Foods
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| Vol #:
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| 164
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| LET 17786
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| NOW Foods
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| Vol #:
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| 164
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| LET 17787
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| NOW Foods
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| Vol #:
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| 164
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| LET 17788
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| NOW Foods
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| Vol #:
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| 164
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| LET 17789
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| NOW Foods
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| Vol #:
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| 164
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| LET 17790
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| NOW Foods
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| Vol #:
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| 164
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| LET 17791
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| NOW Foods
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| Vol #:
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| 164
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| LET 17792
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| NOW Foods
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| Vol #:
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| 164
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| LET 17793
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| NOW Foods
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| Vol #:
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| 164
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| LET 17794
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| NOW Foods
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| Vol #:
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| 164
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| LET 17795
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| NOW Foods
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| Vol #:
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| 164
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| LET 17796
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| NOW Foods
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| Vol #:
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| 164
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| LET 17797
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| NOW Foods
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| Vol #:
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| 164
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| LET 17798
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| NOW Foods
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| Vol #:
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| 164
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| LET 17799
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| NOW Foods
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| Vol #:
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| 164
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| LET 17800
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| NOW Foods
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| Vol #:
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| 164
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| LET 17801
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| NOW Foods
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| Vol #:
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| 164
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| LET 17802
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| NOW Foods
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| Vol #:
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| 164
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| LET 17803
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| NOW Foods
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| Vol #:
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| 164
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| 2000D-1400
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| Reproductive Toxicity Studies preventive vaccines Disease
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| EC 1
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| Ms. Rebecca Jackson
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| Vol #:
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| 1
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| 2000D-1632
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| Management of Adverse Event Reports (AER's) (VICH GL24)
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| EC 1
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| Animal Health Institute
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| Vol #:
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| 1
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| 2005D-0183
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| Guidance for Industry on Antiviral Drug Development Conducting Virology Studies and Submitting the Data to the Agency
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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-0347
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| Biological Products for Treatment of Rare Plasma Protein Disorders
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| C 2
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| Plasma Protein Therapeutics Association (PPTA)
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| Vol #:
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| 1
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| 2005N-0467
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| Medical Devices; Radiology Devices; Reclassification of Bone Sonometers
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| EC 1
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| International Society for Clinical Densitometry
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| Vol #:
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| 1
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| 2005P-0070
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| ANDA Suitability for Oral Salmon Calcitonin
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| PDN 1
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| FDA/CDER to Latham & Watkins LLP
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| Vol #:
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| 1
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| 2005P-0095
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| ANDA 505(b)(2) application for any generic version or other pharmaceutical alternative of Venofer(Iron sucrose injection USP
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| C 1
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| King & Spalding, LLP
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| Vol #:
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| 2
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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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| C 11698
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| R. Baggstrom
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| Vol #:
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| 145
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| C 11699
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| K Zadik
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| Vol #:
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| 145
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| C 11700
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| J M. Rakfeldt
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| Vol #:
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| 145
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| EC 1
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| Duke University
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| Vol #:
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| 1
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| EC 2
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| OncoMethylome Sciences, Inc.
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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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| EC 1
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| Animal Health Institute
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| Vol #:
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| 1
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| 2006D-0191
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| Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
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| EC 1
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| Texas Tech University
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| Vol #:
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| 1
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| 2006N-0104
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
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| EC 2
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| Pharm Res
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| Vol #:
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| 1
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| EC 3
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| Animal Health Institute
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| Vol #:
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| 1
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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| EC 1
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| HV d }sterreichischen Sozialversicherungstr}ger
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| Vol #:
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| 1
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| EC 2
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| F. Hoffmann-La Roche
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| Vol #:
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| 1
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| EC 3
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| Alnis BioSciences, Inc.
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| Vol #:
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| 1
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| EC 4
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| Customized Therapeutics
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| Vol #:
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| 1
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| EC 5
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| Mrs. Heather Drake
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| Vol #:
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| 1
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| 2006N-0180
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experience with Approved New Animal Drugs
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| C 1
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| American Veterinary Medical Association (AVMA)
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| Vol #:
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| 1
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| EC 1
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| American Veterinary Medical Association
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| Vol #:
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| 1
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| EC 2
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| American Veterinary Medical Association
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| Vol #:
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| 1
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| 2006P-0092
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| Determine that Astra Zeneca's Diprivan,Teva Sicor's Propofol Injectable Emulsion, and Bedford Laboratories Propofol Injectable Emulsion are misbranded
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| EC 1
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| Ms. Margaret Keegan
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| Vol #:
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| 1
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| 2006P-0095
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| ANDA suitability for a Piperacillin and Tazobactam for Injection, 13.5 g pharmacy bulk vial
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2006Q-0091
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| Qualified Health Claim (QHC): Unsaturated Fatty Acids from Canola Oil and Reduced Risk of Coronary Heart Disease
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| EC 1
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| Institute of Shortening and Edible Oils
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| Vol #:
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| 5
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