`
`Advisory Committees: CDER 2001 Meeting Documents
`
`FDA Home Page | Dockets Home Page | Dockets Contacts and Location | Operating Status | Federal Register
`
`Up | AC Home Page
`CDER 2001 Meeting Documents
`Anesthetic and Life Support Drugs Advisory Committee
`Anti-Infective Drugs Advisory Committee
`Anti-Viral Drugs Advisory Committee
`Arthritis Advisory Committee
`Cardiovascular and Renal Drugs Advisory Committee
`Endocrinologic and Metabolic Drugs Advisory Committee
`Nonprescription Drugs Advisory Committee
`Oncologic Drugs Advisory Committee
`Peripheral and Central Nervous System Drugs Advisory Committee
`Advisory Committee for Pharmaceutical Science
`Psychopharmacologic Drugs Advisory Committee
`Pulmonary-Allergy Drugs Advisory Committee
`
`Anesthetic and Life Support Drugs Advisory Committee
`Transcript PDF
`Minutes
`Transcript Text ID
`ID
`(size in kb)
`(size in kb)
`(size in kb)
`Start Day
`9/13
`9/14 Due to the events of this week, this meeting has been
`postponed. It will be rescheduled in the future. This
`meeting has been rescheduled for January 30-31,
`2002. You may find additional information at CDER
`2002 page.
`
`Other Docs ID
`(size in kb)
`Draft Agenda
`3778a1_draft.pdf
`
`Questions
`3778q1.pdf
`
`Meeting Info
`m000001.pdf, htm
`
`Briefing Information
`3778b1.htm
`
`Docket Number 01N-
`0256
`
`[ Top ]
`
`Anti-Infective Drugs Advisory Committee
`Transcript PDF
`Transcript Text
`ID
`ID
`(size in kb)
`Start Day
`(size in kb)
`11/07 11/07 Pages 1-100
`[Word version]
`[htm version]
`(8,448)
`
`Minutes
`(size in kb)
`[pdf version] [htm
`version] [Word
`
`Other Docs ID
`(size in kb)
`Final Agenda [Word
`version] [pdf version]
`
`http://www.fda.gov/ohrms/dockets/ac/cder01.htm#Peripheral%20&%20Central%20Nervous
`
`1/16
`AMN 1027
`CBM of U.S. Patent No. 7,895,059
`1 of 16
`
`ROX 1026
`CBM of U.S. Patent No. 7,765,107
`1 of 16
`
`
`
`6/13/2014
`
`Pages 101-200
`(8,549)
`
`Pages 201-307
`(17,286)
`
`Advisory Committees: CDER 2001 Meeting Documents
`version]
`
`[htm version]
`
`Summary Minutes
`(HTM) (PDF) (Word)
`09/12 09/12 Due to the events of this week, this meeting has been postponed. It
`will be rescheduled in the future. Please check here for the new date.
`This meeting was rescheduled for 10/16/01.
`04/26 04/26 Pages 1- 100
`3746t1.rtf (388)
`pdf htm doc
`3746t1_01.pdf
`& html (392)
`(10,540)
`
`Agenda
`3746a1.pdf, htm
`
`
`
`3797t1.[Word
`Version] (477)
`& [HTML
`Version] (394)
`
`10/16 10/16 Pages 1-100
`3797t1_01.pdf
`
`Pages 101-200
`3797t1_02.pdf
`
`Pages 201-300
`3797t1_03.pdf
`
`Pages 301-345
`3797t1_04.pdf
`
`Pages 101-200
`3746t1_02.pdf
`(10,646)
`
`Pages 201-339
`3746t1_03.pdf
`(19,170)
`
`04/23 04/23 3744t1_01.pdf &
`htm
`
`3744t1.rtf
`
`
`
`Draft Agenda [Word
`version] [pdf version]
`[htm version]
`
`Questions [Word
`version] [pdf version]
`[htm version]
`
`Briefing Information
`htm
`
`Slides
`Agenda htm & pdf
`
`Questions htm & pdf
`
`Briefing Information
`
`Roster
`Committee Members
`htm & pdf
`
`Slides 3797s1.htm
`
`Briefing Info.
`3746b1.htm
`
`Roster
`3746r1_01committee.pdf,
`htm
`3746r1_02guest.pdf, htm
`
`Slides
`3746s1.htm
`
`Questions
`pdf htm doc
`Notice of Mtg.
`032301d.htm & pdf
`
`Briefing Information
`3744b1.htm
`
`Agenda
`3744a1.pdf, htm
`
`Roster
`
`http://www.fda.gov/ohrms/dockets/ac/cder01.htm#Peripheral%20&%20Central%20Nervous
`
`2/16
`AMN 1027
`CBM of U.S. Patent No. 7,895,059
`2 of 16
`
`ROX 1026
`CBM of U.S. Patent No. 7,765,107
`2 of 16
`
`
`
`6/13/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`
`
`04/24 3744t2.pdf & htm 3744t2.rtf
`
`
`
`3744r1.pdf, htm
`
`Questions
`3744q1.pdf, htm
`
`Slides
`3744s1.pdf
`Briefing Information
`3744b2.htm
`
`Agenda
`3744a2.pdf, htm
`
`Roster
`3744r2.pdf, htm
`
`Questions
`3744q2.pdf, htm
`
`01/30 01/30 3719t1_01.pdf
`(6126)
`3719t1_02.pdf
`(6374)
`3719t1_03.pdf
`(6385)
`3719t1_04.pdf
`(6428)
`
`[ Top ]
`
`Slides
`3744s2.htm
`3719t1.rtf (439) 3719m1.doc, pdf Briefing Package
`3719b1.htm
`
`Roster
`3719r1.htm
`
`Slides
`3719s1.htm
`
`Agenda
`3719a1.htm
`
`Question
`3719q1.htm
`
`Anti-Viral Drugs Advisory Committee
`Transcript Text
`ID
`(size in kb)
`doc htm
`
`Minutes
`(size in kb)
`
`
`
`Transcript PDF ID
`(size in kb)
`Start Day
`12/12 12/12 Pages 1-100
`
`Pages 101-200
`
`Pages 201-211
`
`Other Docs ID
`(size in kb)
`Notice of Meeting
`[text] [pdf]
`
`Draft Agenda [pdf]
`[htm] [Word]
`
`Final Agenda [pdf]
`[htm] [Word]
`
`Questions [pdf] [htm]
`[Word]
`
`Roster
`Committee [pdf]
`
`http://www.fda.gov/ohrms/dockets/ac/cder01.htm#Peripheral%20&%20Central%20Nervous
`
`3/16
`AMN 1027
`CBM of U.S. Patent No. 7,895,059
`3 of 16
`
`ROX 1026
`CBM of U.S. Patent No. 7,765,107
`3 of 16
`
`
`
`6/13/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`10/03 10/03 Pages 1 - 100 pdf
`(9,207)
`
`htm
`
`Pages 101-200 pdf
`(9,581)
`
`Pages 201-300 pdf
`(10,067)
`
`Pages 301-326 04.pdf
`(8,207)
`
`
`
`10/04 Pages 1 - 100 pdf
`(9,357)
`
`htm
`
`Pages 101-200 pdf
`(9,375)
`
`Pages 201-300 pdf
`(9,990)
`
`Pages 301-327 pdf
`(8,452)
`
`rtf (271)
`
`02/27 02/27 3731t1_01.pdf
`(6394)
`3731t1_02.pdf
`(6275)
`3731t1_03.pdf
`(3920)
`
`01/10 01/10 3676t1_a.pdf
`3676t1_b.pdf
`3676t1_c.pdf
`3676t1_d.pdf
`
`rtf
`
`http://www.fda.gov/ohrms/dockets/ac/cder01.htm#Peripheral%20&%20Central%20Nervous
`
`
`
`
`
`
`
`
`
`[htm] [Word]
`Consultants &
`Guests [pdf] [htm]
`[Word]
`
`Briefing Information
`
`Slides
`Draft Agenda [pdf]
`[htm]
`
`Final Agenda [pdf]
`[htm]
`
`Roster
`Committee [pdf] [htm]
`Consultants &
`Guests [pdf] [htm]
`
`Questions pdf
`
`Briefing Information
`
`Slides
`Agenda pdf &
`htm
`
`Roster
`Committee pdf & htm
`Consultants &
`Guests pdf
`
`Questions pdf
`
`Briefing Information
`htm
`
`Slides htm
`Agenda
`doc, pdf
`
`Slides
`htm
`
`Roster
`Part 1 doc, pdf
`Part 2doc, pdf
`
`Briefing Information
`htm
`
`Questions
`doc, pdf
`Agenda
`doc, pdf
`
`Roster
`
`4/16
`AMN 1027
`CBM of U.S. Patent No. 7,895,059
`4 of 16
`
`ROX 1026
`CBM of U.S. Patent No. 7,765,107
`4 of 16
`
`
`
`6/13/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`
`
`01/11 3678t1_a.pdf
`3678t1_b.pdf
`3678t1_c.pdf
`3678t1_d.pdf
`
`rtf
`
`
`
`[ Top ]
`
`Arthritis Advisory Committee
`Transcript PDF
`Transcript
`ID
`Text ID
`(size in kb)
`(size in kb)
`
`Minutes
`(size in kb)
`
`Start Day
`12/07 12/07
`08/16 08/16 3779t1.pdf (320)
`
`
`
`
`
`
`
`
`
`08/17 Pages 1-100
`3779t2_01.pdf
`
`
`
`3779m2.pdf
`& htm
`
`Pages 101-159
`3779t2_02.pdf
`
`doc, pdf
`
`Briefing Information
`htm
`
`Slides
`htm
`Agenda
`doc, pdf
`
`Briefing Information
`htm
`
`Slides
`htm
`
`Other Docs ID
`(size in kb)
`Closed Meeting
`Agenda
`3779a1.htm & pdf
`
`Rosters
`Committee
`3779r1_committee.htm & pdf
`
`Consultants
`3779r1_consultants.htm & pdf
`
`Public Hearing
`3779r1_public_hearing.htm &
`
`Briefing Information
`3779b1.htm
`
`Questions
`3779q1.htm & pdf
`
`Revised Questions
`3779q1_revised.htm & pdf
`
`Slides
`3779s1.htm
`Agenda
`3779a2.htm & pdf
`
`Rosters
`Committee
`3779r2_committee.htm & pdf
`
`http://www.fda.gov/ohrms/dockets/ac/cder01.htm#Peripheral%20&%20Central%20Nervous
`
`5/16
`AMN 1027
`CBM of U.S. Patent No. 7,895,059
`5 of 16
`
`ROX 1026
`CBM of U.S. Patent No. 7,765,107
`5 of 16
`
`
`
`6/13/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`Consultants
`3779r2_consultants.htm & pdf
`
`Public Hearing
`3779r1_public_hearing.htm &
`
`04/19 04/19 3740t1_01.pdf
`3740t1_02.pdf
`3740t1_03.pdf
`
`3740t1.rtf
`
`
`
`3677t1.rtf (561)
`
`02/07 02/07 3677t1_01.pdf
`(6421)
`3677t1_02.pdf
`(6733)
`3677t1_03.pdf
`(2448)
`
`3677t2.rtf (597)
`
`
`
`02/08 3677t2_01.pdf
`(6774)
`3677t2_02.pdf
`(6852)
`3677t2_03.pdf
`(2918)
`
`Briefing Information
`3779b2.htm
`Agenda
`3740a1.htm & pdf
`
`Briefing Information
`3740b1.htm
`
`Questions
`3740q1.htm & pdf
`
`Roster
`3740r1_01 htm & pdf
`3740r1_02 htm & pdf
`
`Slides
`3740s1.htm
`Agenda
`3677a1.doc, pdf
`
`Roster
`3677r1_01.doc, pdf
`
`Guest Roster
`3677r1_02.doc, pdf
`
`Briefing Information
`3677b1.htm
`
`Questions
`3677q1.doc, pdf
`
`Slides
`3677s1.htm
`Briefing Package
`3677b2.htm
`
`Agenda
`3677a2.doc & pdf
`
`Questions
`3677q2_01.doc & pdf
`3677q2_02.doc & pdf
`
`Slides
`3677s2.htm
`
`[ Top ]
`
`Cardiovascular and Renal Drugs Advisory Committee
`
`http://www.fda.gov/ohrms/dockets/ac/cder01.htm#Peripheral%20&%20Central%20Nervous
`
`6/16
`AMN 1027
`CBM of U.S. Patent No. 7,895,059
`6 of 16
`
`ROX 1026
`CBM of U.S. Patent No. 7,765,107
`6 of 16
`
`
`
`6/13/2014
`
`Transcript PDF ID
`(size in kb)
`
`Start Day
`10/11 10/11 Morning Session
`Pages 1-100 pdf
`
`Advisory Committees: CDER 2001 Meeting Documents
`Transcript Text
`ID
`(size in kb)
`[Word] [htm]
`
`Minutes
`(size in kb)
`
`
`
`Pages 101-129 pdf
`Afternoon Session
`Pages 130-229 pdf
`
`Pages 230-274 pdf
`
`08/09 08/09 Pages 1-100
`3775t1_01.pdf
`
`3775t1.rtf (444)
`
`
`
`Pages 101-200
`3775t1_02.pdf
`
`Pages 201-300
`3775t1_03.pdf
`
`Pages 301-400
`3775t1_04.pdf
`
`Pages 401-411
`3775t1_05.pdf
`
`
`
`08/10 Pages 1-100
`3775t2_01.pdf
`
`3775t2.rtf (299)
`
`
`
`Pages 101-200
`3775t2_02.pdf
`
`5/24
`
`3749t1.rtf (437)
`
`Pages 201-228
`3775t2_03.pdf
`5/24 3749t1_01.pdf
`(9171)
`3749t1_02.pdf
`(8690)
`3749t1_03.pdf
`(7469)
`3749t1_04.pdf
`(4025)
`5/25 3749t2_01.pdf
`(9171)
`3749t2_02.pdf
`(8465)
`3749t2_03.pdf
`(8352)
`3749t2_04.pdf
`http://www.fda.gov/ohrms/dockets/ac/cder01.htm#Peripheral%20&%20Central%20Nervous
`
`
`
`3749t2.rtf (465)
`
`
`
`
`
`Other Docs ID
`(size in kb)
`Agenda
`3793a1.htm & pdf
`
`Briefing Information
`
`Questions
`3793q1.htm & pdf
`
`Slides 3793s1.htm
`Agenda
`3775a1.htm, pdf
`
`Roster
`3775r1.htm
`
`Briefing Information
`3775b1.htm
`
`Questions
`Remondulin
`3775q1_01.pdf, htm
`
`Extraneal
`3775q1_02.pdf, htm
`
`Slides
`3775s1.htm
`Briefing Information
`3775b2.htm
`
`Questions
`bosenton
`3775q2.pdf, htm
`
`Briefing Information
`3749b1.htm
`
`Agenda
`3749a1.pdf & htm
`
`Questions
`3749q1.pdf & htm
`
`Briefing Information
`3749b2.htm
`
`Questions
`3749q2.pdf & htm
`
`7/16
`AMN 1027
`CBM of U.S. Patent No. 7,895,059
`7 of 16
`
`ROX 1026
`CBM of U.S. Patent No. 7,765,107
`7 of 16
`
`
`
`6/13/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`(7345)
`
`[ Top ]
`
`Endocrinologic and Metabolic Drugs Advisory Committee
`Transcript PDF
`Transcript Text
`ID
`ID
`(size in kb)
`Start Day
`(size in kb)
`3761t1.htm
`07/26 07/26 Pages 1-100
`3761t1_01.pdf
`(9,446)
`
`Minutes
`(size in kb)
`3761m1.pdf &
`htm
`
`Other Docs ID
`(size in kb)
`Notice of Meeting
`June 8, 2001 txt
`
`Pages 101-200
`3761t1_02.pdf (9,613)
`
`Pages 201-300
`3761t1_03.pdf (9,586)
`
`Pages 301-342
`3761t1_04.pdf (8,306)
`
`
`
`07/27 Pages 1-100
`3761t2_01.pdf
`(8,398)
`
`3761t2.htm
`
`3761m2.pdf &
`htm
`
`Pages 101-200
`3761t2_02.pdf (8,508)
`
`Pages 201-300
`3761t2_03.pdf (8,318)
`
`Pages 301-359
`3761t2_04.pdf (9,991)
`
`[ Top ]
`
`Agenda
`3761a1.pdf, htm
`
`Questions
`3761q1.pdf, htm
`
`Briefing Information
`3761b1.htm
`
`Slides
`3761s1.htm
`Agenda
`3761a2.pdf, htm
`
`Questions
`3761q2.pdf, htm
`
`Roster
`3761r2.pdf, htm
`
`Briefing Information
`3761b2.htm
`
`Slides
`3761t2.htm
`
`Start Day
`
`Nonprescription Drugs Advisory Committee
`Transcript PDF
`Transcript Text
`Minutes
`ID
`ID
`(size in kb)
`(size in kb)
`(size in kb)
`Joint meeting with Pulmonary-Allergy Drugs Advisory Committee
`05/11 05/11 Pages 1-100
`3737t1.rtf
`3737m1.pdf, html Agenda
`3737t1_01.pdf
`3737a1.htm, pdf
`
`Other Docs ID
`(size in kb)
`
`Pages 101-200
`3737t1_02.pdf
`
`Pages 201-300
`3737t1_03.pdf
`
`http://www.fda.gov/ohrms/dockets/ac/cder01.htm#Peripheral%20&%20Central%20Nervous
`
`Planning Agenda
`3737a1_planning.htm,
`
`Questions
`
`8/16
`AMN 1027
`CBM of U.S. Patent No. 7,895,059
`8 of 16
`
`ROX 1026
`CBM of U.S. Patent No. 7,765,107
`8 of 16
`
`
`
`6/13/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`Pages 301-345
`3737t1_04.pdf
`
`[ Top ]
`
`Minutes
`(size in kb)
`
`Oncologic Drugs Advisory Committee
`Transcript PDF
`Transcript Text
`ID
`ID
`(size in kb)
`Start Day
`(size in kb)
`12/05 12/05 Pages 1-100
`
`rtf
`
`
`
`3737q1.htm, pdf
`
`Roster
`Consultants
`3737r1_01.htm & pdf
`
`Members
`3737r1_02.htm & pdf
`
`Open Public Hearing
`3737r1_03.htm & pdf
`
`Briefing Information
`3737b1.htm
`Petition
`
`Slides 3737s1.htm
`
`Open Public Hearing
`Presentations
`3737op1.htm
`
`Other Docs ID
`(size in kb)
`Draft Agenda
`3815a1 [pdf version]
`[htm version] [Word
`version]
`
`Briefing Information
`Morning Session
`3815b1_01.htm
`
`Afternoon Session
`3815b1_02.htm
`
`Slides
`Briefing Information
`Morning Session
`3815b2_01.htm
`
`Afternoon Session
`3815b2_02.htm
`
`Slides
`
`Draft Agenda
`3803a1.[Word
`version] [htm version]
`[pdf version]
`
`Pages 101-200
`
`Pages 201-300
`
`Pages 301-362
`
`
`
`12/06 Pages 1-100
`
`rtf
`
`
`
`Pages 101-200
`
`Pages 201-300
`
`Pages 301-397
`
`11/28 11/28 Morning Session
`Pages 1-100 pdf
`
`Pages 101-202
`
`Pediatric Subcommittee
`[Word] [htm]
`
`
`http://www.fda.gov/ohrms/dockets/ac/cder01.htm#Peripheral%20&%20Central%20Nervous
`
`9/16
`AMN 1027
`CBM of U.S. Patent No. 7,895,059
`9 of 16
`
`ROX 1026
`CBM of U.S. Patent No. 7,765,107
`9 of 16
`
`
`
`6/13/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`Afternoon Session
`Pages 203-302
`
`Pages 303-405 pdf
`
`09/10 09/10 Morning Session
`Pages 1-100
`3782t1_01a.pdf
`(10,008) Pages
`101-179
`3782t1_01b.pdf
`
`Morning Session
`3782t1_01.htm
`(139)
`
`
`
`Afternoon Session
`3782t1_02.htm
`
`Afternoon Session
`Pages 1-100
`3782t1_02a.pdf
`(9,796) Pages 101-
`200 3782t1_02b.pdf
`(9,878)
`Pages 201-225
`3782t1_02c.pdf
`(2,226)
`
`3782t2.htm
`
`
`
`
`
`09/11 Pages 1-100
`3782t2_01.pdf
`Pages 101-200
`3782t2_02.pdf
`Pages 201-239
`3782t2_03.pdf
`
`06/28 06/28 Pages 1-100
`3756t1_01.pdf
`
`Pediatric Subcommittee
`3756t1.rtf,
`
`3756t1.txt
`
`Pages 101-200
`3756t1_02.pdf
`
`Pages 201-end
`3756t1_03.pdf
`
`06/07 06/07 Pages 1-100
`3757t1_01.pdf
`http://www.fda.gov/ohrms/dockets/ac/cder01.htm#Peripheral%20&%20Central%20Nervous
`
`3757t1.txt, htm
`
`
`
`Roster 3803r1.[Word
`version] [htm version] [pdf
`version]
`
`Questions 3803q1. [Word
`version] [htm version] [pdf
`version]
`
`Briefing Information
`3803b1.htm
`
`Slides 3803s1.htm
`
`Agenda
`3782a1.pdf & htm
`Revised Agenda
`3782a1_revised.pdf
`& htm
`
`Roster
`3782r1.pdf & htm
`Consultants
`3782r1_consultants.pdf
`& htm
`
`Questions
`3782q1.pdf & htm
`Intradose 3782q1_02. pdf
`& htm
`
`Briefing Information
`3782b1.htm
`
`Slides 3782s1.htm
`Briefing Information
`3782b2.htm
`
`Questions
`3782q2_zevalin.pdf &
`htm
`
`Slides 3782s2.htm
`
`Agenda
`3756a1.htm, pdf
`
`Roster
`3756r1.htm, pdf
`
`Briefing Information htm
`
`Slides
`3756s1.htm
`Agenda
`3757a1.htm & pdf
`
`10/16
`AMN 1027
`CBM of U.S. Patent No. 7,895,059
`10 of 16
`
`ROX 1026
`CBM of U.S. Patent No. 7,765,107
`10 of 16
`
`
`
`6/13/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`Pages 101-201
`3757t1_02.pdf
`
`4/24
`
`4/24 3743t1_01.pdf
`3743t1_02.pdf
`3743t1_03.pdf
`
`Pediatric Subcommittee
`3743t1.rtf
`
`
`Questions
`3757q1.htm & pdf
`
`Briefing Information
`3757b1.htm & pdf
`
`Agenda
`3743a1.htm & pdf
`
`Roster
`3743r1.htm, pdf
`
`Briefing Information
`3743b1.htm & pdf
`
`Slides
`3743s1.htm
`
`[ Top ]
`
`Peripheral & Central Nervous System Drugs Advisory Committee
`Transcript PDF
`Transcript Text
`ID
`ID
`(size in kb)
`Start Day
`(size in kb)
`6/6
`6/6 Pages 1-100
`3754t1.txt
`3754t1_01.pdf
`
`Other Docs ID
`Minutes
`(size in kb)
`(size in kb)
`3754m1.pdf, html Agenda
`3754a1.pdf, html
`
`Pages 101-200
`3754t1_02.pdf
`
`Pages 201-300
`3754t1_03.pdf
`
`Pages 301-381
`3754t1_04.pdf
`
`3/13
`
`3/13 3724t1.pdf
`
`3724t1.rtf
`
`3724m1.htm
`3742m1.pdf
`
`Rosters
`Members
`3754r1_01.pdf, html
`
`Consultants
`3754r1_02.pdf, html
`
`Public Hearing
`3754r1_03.pdf, html
`
`Questions
`3754q1.pdf, html
`
`Briefing Information
`3754b1.htm
`
`Slides
`3754s1.htm
`Agenda
`3724a1.doc, pdf
`
`Roster
`3724r1_01.doc, pdf
`
`Briefing Info
`3724b1.htm
`
`Slides
`
`http://www.fda.gov/ohrms/dockets/ac/cder01.htm#Peripheral%20&%20Central%20Nervous
`
`11/16
`AMN 1027
`CBM of U.S. Patent No. 7,895,059
`11 of 16
`
`ROX 1026
`CBM of U.S. Patent No. 7,765,107
`11 of 16
`
`
`
`6/13/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`
`
`3/14 3724t2.pdf
`
`3724t2.rtf
`
`3724m2.htm
`3724m2.pdf
`
`3724s1.htm
`Agenda (DRAFT)
`3724a2.doc, pdf
`
`Roster
`3724r1_02.doc, pdf
`
`Briefing Info
`3724b2.htm
`
`Slides
`3724s2.htm
`
`[ Top ]
`
`Advisory Committee for Pharmaceutical Science
`Transcript PDF
`Transcript Text
`ID
`ID
`(size in kb)
`Start Day
`(size in kb)
`[Word] [htm]
`11/28 11/28 Morning Session
`Pages 1-100
`
`Minutes
`(size in kb)
`
`
`
`Other Docs ID
`(size in kb)
`Revised Agenda
`[pdf version] [htm
`version] [Word
`version]
`
`Draft Agenda 3804a1
`[pdf version]
`
`Rosters
`Committee: 3804r1
`[pdf version] [htm
`version] [Word
`version]
`Guests: [pdf version]
`[htm version] [Word
`version]
`
`Briefing Information
`3804b1.htm
`
`Slides
`Revised Agenda
`[pdf version] [htm
`version] [Word
`version]
`
`Committee: 3804r1
`[pdf version] [htm
`version] [Word
`version]
`Guests: [pdf version]
`[htm version] [Word
`version]
`
`Briefing Information
`
`Pages 101-143
`
`Afternoon Session
`Pages 144-243
`
`Pages 244-282
`
`
`
`11/29 Morning Session
`Pages 1-100
`
`[Word] [htm]
`
`
`
`Pages 101-141
`
`Afternoon Session
`Pages 142-243
`
`Pages 244-294
`
`http://www.fda.gov/ohrms/dockets/ac/cder01.htm#Peripheral%20&%20Central%20Nervous
`
`12/16
`AMN 1027
`CBM of U.S. Patent No. 7,895,059
`12 of 16
`
`ROX 1026
`CBM of U.S. Patent No. 7,765,107
`12 of 16
`
`
`
`6/13/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`11/13 11/13 Pages 1-100
`(10,038)
`
`Pages 101-148
`(6,901)
`
`Nonclinical Studies Subcommittee
`[htm version]
`[pdf] [htm] [Word] Draft Agenda
`[Word version]
`3798a1. [htm
`format] & [pdf
`format]
`
`3804b2.htm
`
`Slides
`
`Roster Committee
`Members
`[htm format] & [pdf
`format]
`Guests
`[htm format] & [pdf
`format]
`
`07/19 07/19 Pages 1-100
`3763t1_01.pdf
`
`3763t1.htm, txt
`
`Briefing Information
`3798b1.htm
`3763m1.htm & pdf Agenda
`3763a1.htm & pdf
`
`Pages 101-200
`3763t1_02.pdf
`
`Pages 201-300
`3763t1_03.pdf
`
`Pages 301-313
`3763t1_04.pdf
`
`
`
`7/20 Pages 1-100
`3763t2_01.pdf
`
`3763t2.htm, txt
`
`Pages 101-171
`3763t2_02.pdf
`
`Roster
`3763r1.htm & pdf
`Guest Roster
`3763r1_guest.doc &
`FDA Roster
`3763r1_fda.doc & pdf
`
`Questions
`3763q2.htm & pdf
`
`Briefing Information
`3763b1.htm
`
`Slides
`3763s1.htm
`3763m2.htm & pdf Agenda
`3763a2.htm & pdf
`
`7/17
`
`Orally Inhaled and Nasal Drug Products Subcommittee
`7/17 Pages 1-100
`3764t1.htm, txt
`3764m1.htm &
`3764t1_01.pdf
`
`Pages 101-200
`3764t1_02.pdf
`
`http://www.fda.gov/ohrms/dockets/ac/cder01.htm#Peripheral%20&%20Central%20Nervous
`
`Guest Roster
`3763r2_guest.doc &
`FDA Roster
`3763r2_fda.doc & pdf
`
`Slides
`3763s2.htm
`
`Agenda
`3764a1.htm & pdf
`
`Roster
`3764r1.htm & pdf
`
`13/16
`AMN 1027
`CBM of U.S. Patent No. 7,895,059
`13 of 16
`
`ROX 1026
`CBM of U.S. Patent No. 7,765,107
`13 of 16
`
`
`
`6/13/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`Pages 201-211
`3764t1_03.pdf
`
`5/3
`
`5/3
`
`3742t1.pdf
`(10,036)
`
`Non-Clinical Studies Subcommittee
`3742t1.rtf (93)&
`
`html (100 )
`
`[ Top ]
`
`Open Speakers
`3764r1.htm & pdf
`
`Questions
`3764q1.htm & pdf
`
`Briefing Information
`3764b1.htm
`
`Slides
`3764s1.htm
`
`Agenda
`3742a1.htm & pdf
`
`Roster
`3742r1.htm & pdf
`3742r2.htm & pdf
`
`Briefing Info
`3742b1.htm & pdf
`
`Notice of Meeting
`98frx032301g.htm
`98frx032301g.pdf
`
`Psychopharmacologic Drugs Advisory Committee
`Transcript PDF
`Transcript Text
`ID
`ID
`(size in kb)
`Start Day
`(size in kb)
`2/14
`2/14 3685t1.pdf
`3685t1.txt
`
`Minutes
`(size in kb)
`3685m1.pdf
`
`Other Docs ID
`(size in kb)
`Agenda
`3685a1.doc, pdf
`
`
`
`2/15 3685t2.pdf
`
`3685t2.txt
`
`3685m2.pdf
`
`Roster
`3685r1.doc, pdf
`
`Questions
`3685q1.doc, pdf
`
`Briefing Info
`3685b1.htm
`
`Slides
`3685s1.htm
`Agenda
`3685a2.doc, pdf
`
`Roster
`3685r2.doc, pdf
`
`Questions
`3685q2.doc, pdf
`
`http://www.fda.gov/ohrms/dockets/ac/cder01.htm#Peripheral%20&%20Central%20Nervous
`
`14/16
`AMN 1027
`CBM of U.S. Patent No. 7,895,059
`14 of 16
`
`ROX 1026
`CBM of U.S. Patent No. 7,765,107
`14 of 16
`
`
`
`6/13/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`Briefing Info
`3685b2.htm
`
`Slides
`3685s2.htm
`
`[ Top ]
`
`Pulmonary-Allergy Drugs Advisory Committee
`Transcript PDF
`Transcript Text
`Minutes
`ID
`ID
`(size in kb)
`(size in kb)
`(size in kb)
`Joint meeting with Nonprescription Drugs Advisory Committee
`3737t1.rtf
`05/11 05/11 Pages 1-100
`3737m1.pdf, html Agenda
`3737t1_01.pdf
`3737a1.htm, pdf
`
`Other Docs ID
`(size in kb)
`
`Start Day
`
`Pages 101-200
`3737t1_02.pdf
`
`Pages 201-300
`3737t1_03.pdf
`
`Pages 301-345
`3737t1_04.pdf
`
`
`Planning Agenda
`3737a1_planning.htm,
`
`Questions
`3737q1.htm, pdf
`
`Roster
`Consultants
`3737r1_01.htm & pdf
`
`Members
`3737r1_02.htm & pdf
`
`Open Public Hearing
`3737r1_03.htm & pdf
`
`Briefing Information
`3737b1.htm
`Petition
`
`Slides 3737s1.htm
`
`Open Public Hearing
`Presentations
`3737op1.htm
`
`Page updated: March 27, 2007
`
`Top | Up | AC Home Page
`
`Dockets Home Page | Dockets Contacts and Location | Operating Status | Federal Registers
`FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
`
`FDA/Dockets Management
`
`http://www.fda.gov/ohrms/dockets/ac/cder01.htm#Peripheral%20&%20Central%20Nervous
`
`15/16
`AMN 1027
`CBM of U.S. Patent No. 7,895,059
`15 of 16
`
`ROX 1026
`CBM of U.S. Patent No. 7,765,107
`15 of 16
`
`
`
`6/13/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`http://www.fda.gov/ohrms/dockets/ac/cder01.htm#Peripheral%20&%20Central%20Nervous
`
`16/16
`AMN 1027
`CBM of U.S. Patent No. 7,895,059
`16 of 16
`
`ROX 1026
`CBM of U.S. Patent No. 7,765,107
`16 of 16
`
`