Recently Updated Advisory Committee Materials

Recently Updated Advisory Committee Materials

Posted on March 19, 2010
Pediatric Advisory CommitteeCardiolite: Use Review1 (PDF - 73KB)
Orlistat: Additional Reference Information2
Zmax: Maternal Health Team Review3 (PDF - 146KB)
Rotarix: Labeling Change Information4
Orlistat: Labeling5 (PDF - 318KB)
Briefing Information for the March 22, 2010 Meeting of the Pediatric Advisory Committee6
Zmax: Addendum Memo7 (PDF - 20KB)
Vaccine Background Reference Information8
Topical Calcineurin Inhibitors: Safety Review - Addendum9 (PDF - 63KB)
Topical Calcineurin Inhibitors: Abstract Reference Information10

Orthopaedic and Rehabilitation Devices Panel
Rodeo JBJS Commentary and Perspective11 (PDF - 5KB)
Becker 2006 final12 (PDF - 5KB)
Regen 510K Summary13 (PDF - 70KB)
Depuy Restore Instructions for Use14 (PDF - 659KB)
Redacted Surgical Technique from IDE15 (PDF - 929KB)
Meeting Agenda16 (DOC - 54KB)
Briggs 2006 Final17 (PDF - 5KB)
Acute Study Arm Protocol18 (PDF - 1663KB)
Part 1 - IDE Study CRFs19 (PDF - 449KB)
Parsons Shoulder Joint 2002 Final20 (PDF - 5KB)
Predicate Mesh Comparison Table21 (PDF - 78KB)
Regen CS Instructions for Use22 (PDF - 108KB)
European Feasibility Article Final23 (PDF - 5KB)
Fithian Meniscus Properties 1990 Final24 (PDF - 5KB)
Krause Meniscus 1976 Final25 (PDF - 5KB)
510(k) SE Flowchart26 (PDF - 32KB)
FDA Executive Summary27 (PDF - 900KB)
Panel Questions28 (PDF - 35KB)
Regen Executive Summary29 (PDF - 6107KB)
Redacted Cleared Package Insert30 (PDF - 192KB)
CMI Feasibility Trial 2 year follow-up Final31 (PDF - 5KB)
Chronic Study Arm32 (PDF - 1667KB)
Redacted 2008 Panel Transcript33 (PDF - 391KB)
Part 2 - IDE Study CRFs34 (PDF - 449KB)
JBJS Article35 (PDF - 5KB)
Regen Sponsor Summary36 (PDF - 9609KB)

Oncologic Drugs Advisory Committee
Final Questions for the March 22, 2010 Meeting of the Oncologic Drugs Advisory Committee-AM Session-Cell Therapeutics37 (PDF - 62KB)
Final Questions for the March 22, 2010 Meeting of the Oncologic Drugs Advisory Committee-PM Session-ChemGenex38 (PDF - 23KB)
2010 Meeting Materials, Oncologic Drugs Advisory Committee39

Veterinary Medicine Advisory Committee
2010 VMAC Meeting Materials40
ADE Case Reports41 (PDF - 2051KB)
ProHeart® 6 Briefing Package42 (PDF - 153KB)
Roster for the ProHeart® 6 Veterinary Medicine Advisory Committee43
ProHeart® 6 Label44 (PDF - 251KB)
Draft Agenda for the March 24, 2010 Meeting of the Veterinary Medicine Advisory Committee45


-Posted on March 18, 2010
Oncologic Drugs Advisory Committee

Briefing Information for the March 22, 2010 Meeting of the Oncologic Drugs Advisory Committee46

Vaccines and Related Biological Products Advisory Committee
2009 Meeting Materials, Vaccines and Related Biological Products Advisory Committee47

Advisory Committee Calendar
April 22, 2010: Joint Meeting of the Anesthetic and Life Support Drugs and Drug
Safety and Risk Management Advisory Committee Meeting Announcement48


-Posted on March 17, 2010
Advisory Committee CalendarApril 12, 2010: Blood Products Advisory Committee Meeting Announcement49
May 6, 2010: Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement50

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http://www.fda.gov/AdvisoryCommittees/WhatsNew/default.htm