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Dockets Management
Dockets Entered On July 30, 2007
Docket # Title
2004D-0333 Emergency Use Authorization of Medical Products
2005N-0329 Designation of New Animal Drugs for Minor Uses or Minor Species
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2006D-0108 Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs
2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
2006N-0283 Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Survey of Physicians Perceptions of the Impact of Early Risk Communication about Medical Products
2006N-0362 General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
2007D-0201 Guidance for Industry and Food and Drug Administration Staff; Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents
2007D-0213 Guidance for Industry on Providing Regulatory Submissions in Electronic Format Receipt Date
2007D-0252 Guidance for Industry and Food and Drug Administration Staff; Pulse Oximeters - Premarket Notification Submissions 510(k)s
2007D-0290 Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
2007N-0050 Agency Information Collection Activities; Proposed Collection; Comment Request; Label Comprehension Study
2007N-0155 Defining and Implementing Quality in Clinical Investigations: From Design to Completion; Public Workshop
2007N-0277 Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
2007N-0278 Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Registration of Cosmetic Product Establishments
2007P-0033 Amend the Nutrition Facts label on food products as it relates to trans fats
2007P-0044 Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis
2007P-0296 Request that the FDA requires labeling changes for Skelaxin (active ingredient metaxalone) as set forth in the proposed revised packaging insert
2007P-0297 Request to reconsider the failure to approve Provenge
2004D-0333 Emergency Use Authorization of Medical Products
GDL 2 Guidance Vol #: 1
NAD 2 FDA Vol #: 1
2005N-0329 Designation of New Animal Drugs for Minor Uses or Minor Species
NFR 1 FDA Vol #: 1
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 18331 P. Williams Vol #: 198
2006D-0108 Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs
C 2 Plasma Protein Therapeutics Association Vol #: 1
2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
GDL 2 Guidance Vol #: 3
NAD 2 FDA Vol #: 3
2006N-0283 Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Survey of Physicians Perceptions of the Impact of Early Risk Communication about Medical Products
N 2 FDA Vol #: 1
2006N-0362 General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
EC 4 Miss. Beth Lamond Vol #: 1
2007D-0201 Guidance for Industry and Food and Drug Administration Staff; Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2007D-0213 Guidance for Industry on Providing Regulatory Submissions in Electronic Format Receipt Date
C 1 Wyeth Pharmaceuticals, Inc. Vol #: 1
2007D-0252 Guidance for Industry and Food and Drug Administration Staff; Pulse Oximeters - Premarket Notification Submissions 510(k)s
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2007D-0290 Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2007N-0050 Agency Information Collection Activities; Proposed Collection; Comment Request; Label Comprehension Study
EC 1 Harter's Drug Store Vol #: 1
EC 2 CustomYourShirt Vol #: 1
EC 3 Mr. Don Lee Vol #: 1
2007N-0155 Defining and Implementing Quality in Clinical Investigations: From Design to Completion; Public Workshop
C 2 Bristol-Meyers Squibb Company (BMS) Vol #: 1
2007N-0277 Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
EC 1 Mr. norman sharette Vol #: 1
2007N-0278 Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Registration of Cosmetic Product Establishments
N 1 FDA Vol #: 1
2007P-0033 Amend the Nutrition Facts label on food products as it relates to trans fats
LET 1 FDA/CFSAN to Ellen Ashworth Vol #: 1
2007P-0044 Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis
LET 1 FDA/ CDER to Sidney M. Wolfe, M.D. Vol #: 1
2007P-0296 Request that the FDA requires labeling changes for Skelaxin (active ingredient metaxalone) as set forth in the proposed revised packaging insert
ACK 1 FDA /DDM to Zuckerman Spaeder LLP Vol #: 1
2007P-0297 Request to reconsider the failure to approve Provenge
ACK 1 FDA/DDM to CareToLive Vol #: 1
CP 1 CareToLive Vol #: 1

Page created on July 31, 2007 ue

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