`
`CDER 2001 Advisory Committee Meeting Documents
`
`http://w w w .fda.gov/ohrms/dockets/ac/cder01.htm
`
`Go
`
`99 captures
`24 Jan 01 - 12 Jul 12
`
`JUN OCT NOV
`
`4
`
`2000
`
`2001
`
`2002
`
`[ Federal Registers ] [ FDA Home Page ][Dockets Home Page][CBER][CDRH][OC][Up][AC What's New]
`[Accessibility] [E-mail ] Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD,
`20852; 301-827-6860; Fax 301-827-6870
`
`CDER 2001 Meeting Documents
`
`Anesthetic and Life Support Drugs Advisory Committee
`Transcript PDF ID
`Transcript Text ID
`Minutes
`(size in kb)
`Day
`(size in kb)
`(size in kb)
`9/14 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.
`
`Start
`9/13
`
`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 ]
`
`Start
`09/12
`
`4/26
`
`
`
`Anti-Infective Drugs Advisory Committee
`Other Docs ID
`Transcript Text ID
`Minutes
`Transcript PDF ID
`(size in kb)
`(size in kb)
`(size in kb)
`Day
`(size in kb)
`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.
`4/26 Pages 1- 100
`3746t1.rtf (388) & html
`3746t1_01.pdf
`(392)
`(10,540)
`
`Pages 101-200
`3746t1_02.pdf
`(10,646)
`
`Pages 201-339
`3746t1_03.pdf
`(19,170)
`
`4/23
`
`4/23
`
`3744t1_01.pdf & htm
`
`3744t1.rtf
`
`
`
`Agenda
`3746a1.pdf, htm
`
`Briefing Info.
`3746b1.htm
`
`Roster
`3746r1_01committee.pdf,
`htm
`3746r1_02guest.pdf, htm
`
`Slides
`3746s1.htm
`
`Notice of Mtg.
`032301d.htm & pdf
`
`Briefing Information
`3744b1.htm
`
`https://web.archive.org/web/20011004081740/http://www.fda.gov/ohrms/dockets/ac/cder01.htm
`
`1/11
`
`Wockhardt 1020
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`
`
`5/13/2014
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`CDER 2001 Advisory Committee Meeting Documents
`
`
`
`4/24
`
`3744t2.pdf & htm
`
`3744t2.rtf
`
`
`
`01/30
`
`01/30 3719t1_01.pdf (6126)
`3719t1_02.pdf (6374)
`3719t1_03.pdf (6385)
`3719t1_04.pdf (6428)
`
`3719t1.rtf (439)
`
`3719m1.doc, pdf
`
`[ Top ]
`
`Start
`10/03
`
`Day
`10/03
`
`Transcript PDF ID
`(size in kb)
`
`Anti-Viral Drugs Advisory Committee
`Transcript Text ID
`Minutes
`(size in kb)
`(size in kb)
`
`
`
`
`
`https://web.archive.org/web/20011004081740/http://www.fda.gov/ohrms/dockets/ac/cder01.htm
`
`Agenda
`3744a1.pdf, htm
`
`Roster
`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
`
`Slides
`3744s2.pdf
`Briefing Package
`3719b1.htm
`
`Roster
`3719r1.htm
`
`Slides
`3719s1.htm
`
`Agenda
`3719a1.htm
`
`Question
`3719q1.htm
`
`Other Docs ID
`(size in kb)
`Draft Agenda 3792a1.pdf
`& htm
`
`Final Agenda
`3792a1.pdf & htm
`
`Roster
`Committee
`3792r1_01.pdf & htm
`Consultants & Guests
`
`2/11
`
`Wockhardt 1020
`
`
`
`5/13/2014
`
`CDER 2001 Advisory Committee Meeting Documents
`
`
`
`10/04
`
`
`
`2/27
`
`2/27
`
`3731t1_01.pdf (6394)
`3731t1_02.pdf (6275)
`3731t1_03.pdf (3920)
`
`3731t1.rtf (271)
`
`1/10
`
`1/10
`
`3676t1_a.pdf
`3676t1_b.pdf
`3676t1_c.pdf
`3676t1_d.pdf
`
`3676t1.rtf
`
`
`
`1/11
`
`3678t1_a.pdf
`3678t1_b.pdf
`3678t1_c.pdf
`3678t1_d.pdf
`
`3578t1.rtf
`
`
`
`
`
`
`
`
`
`3792r1_02.pdf
`
`Questions 3792q1.pdf
`
`Briefing Information
`3792b1.htm
`Agenda 3792a2.pdf &
`htm
`
`Roster
`Committee
`3792r2_01.pdf & htm
`Consultants & Guests
`3792r2_02.pdf
`
`Questions 3792q2.pdf
`
`Briefing Information
`3792b2.htm
`Agenda
`3731a1.doc, pdf
`
`Slides
`3731s1.htm
`
`Roster
`3731r1.doc, pdf
`3731r2.doc, pdf
`
`Briefing Information
`3731b1.htm
`
`Questions
`3731q1.doc, pdf
`
`Agenda
`3676a1.doc, pdf
`
`Roster
`3676r1.doc, pdf
`
`Briefing Information
`3676b1.htm
`
`Slides
`3676s1.htm
`Agenda
`3678a1.doc, pdf
`
`Briefing Information
`3678b1.htm
`
`Slides
`3678s1.htm
`
`[ Top ]
`
`https://web.archive.org/web/20011004081740/http://www.fda.gov/ohrms/dockets/ac/cder01.htm
`
`3/11
`
`Wockhardt 1020
`
`
`
`5/13/2014
`
`Start
`8/16
`
`Day
`8/16
`
`Transcript PDF ID
`(size in kb)
`3779t1.pdf (320)
`
`
`
`CDER 2001 Advisory Committee Meeting Documents
`Arthritis Advisory Committee
`Transcript Text ID
`Minutes
`(size in kb)
`(size in kb)
`
`
`
`Other Docs ID
`(size in kb)
`
`Agenda
`3779a1.htm & pdf
`
`Rosters
`Committee
`3779r1_committee.htm & pdf
`
`Consultants
`3779r1_consultants.htm & pdf
`
`Public Hearing
`3779r1_public_hearing.htm & pdf
`
`Briefing Information
`3779b1.htm
`
`Questions
`3779q1.htm & pdf
`
`Revised Questions
`3779q1_revised.htm & pdf
`
`
`
`8/17
`
`
`
`Pages 1-100
`3779t2_01.pdf
`
`Pages 101-159
`3779t2_02.pdf
`
`Slides
`3779s1.htm
`3779m2.pdf & htm Agenda
`3779a2.htm & pdf
`
`Rosters
`Committee
`3779r2_committee.htm & pdf
`
`Consultants
`3779r2_consultants.htm & pdf
`
`Public Hearing
`3779r1_public_hearing.htm & pdf
`
`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
`
`4/19
`
`4/20
`
`3740t1_01.pdf
`3740t1_02.pdf
`3740t1_03.pdf
`
`3740t1.rtf
`
`
`
`https://web.archive.org/web/20011004081740/http://www.fda.gov/ohrms/dockets/ac/cder01.htm
`
`4/11
`
`Wockhardt 1020
`
`
`
`5/13/2014
`
`CDER 2001 Advisory Committee Meeting Documents
`
`2/7
`
`2/7
`
`3677t1_01.pdf (6421)
`3677t1_02.pdf (6733)
`3677t1_03.pdf (2448)
`
`3677t1.rtf (561)
`
`
`
`
`
`02/08
`
`3677t2_01.pdf (6774)
`3677t2_02.pdf (6852)
`3677t2_03.pdf (2918)
`
`3677t2.rtf (597)
`
`
`
`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 ]
`
`Start
`08/09
`
`Cardiovascular and Renal Drugs Advisory Committee
`Transcript PDF ID
`Transcript Text ID
`Minutes
`(size in kb)
`Day
`(size in kb)
`(size in kb)
`08/09 Pages 1-100
`3775t1.rtf (444)
`3775t1_01.pdf
`
`
`
`Pages 101-200
`3775t1_02.pdf
`
`Pages 201-300
`3775t1_03.pdf
`
`Pages 301-400
`3775t1_04.pdf
`
`Pages 401-411
`3775t1_05.pdf
`
`https://web.archive.org/web/20011004081740/http://www.fda.gov/ohrms/dockets/ac/cder01.htm
`
`Other Docs ID
`(size in kb)
`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
`
`5/11
`
`Wockhardt 1020
`
`
`
`5/13/2014
`
`
`
`CDER 2001 Advisory Committee Meeting Documents
`
`08/10 Pages 1-100
`3775t2_01.pdf
`
`3775t2.rtf (299)
`
`Pages 101-200
`3775t2_02.pdf
`
`Pages 201-228
`3775t2_03.pdf
`3749t1_01.pdf (9171)
`3749t1_02.pdf (8690)
`3749t1_03.pdf (7469)
`3749t1_04.pdf (4025)
`
`5/24
`
`5/24
`
`3749t1.rtf (437)
`
`
`
`5/25
`
`3749t2_01.pdf (9171)
`3749t2_02.pdf (8465)
`3749t2_03.pdf (8352)
`3749t2_04.pdf (7345)
`
`3749t2.rtf (465)
`
`
`
`
`
`
`
`[ Top ]
`
`Start
`07/26
`
`Endocrinologic and Metabolic Drugs Advisory Committee
`Transcript PDF ID
`Transcript Text ID
`Minutes
`(size in kb)
`Day
`(size in kb)
`(size in kb)
`07/26 Pages 1-100
`3761t1.htm
`3761m1.pdf & htm
`3761t1_01.pdf (9,446)
`
`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)
`
`https://web.archive.org/web/20011004081740/http://www.fda.gov/ohrms/dockets/ac/cder01.htm
`
`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
`
`Other Docs ID
`(size in kb)
`Notice of Meeting
`June 8, 2001 txt pdf
`
`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
`
`6/11
`
`Wockhardt 1020
`
`
`
`5/13/2014
`
`[ Top ]
`
`CDER 2001 Advisory Committee Meeting Documents
`
`3761t2.htm
`
`Nonprescription Drugs Advisory Committee
`Transcript PDF ID
`Transcript Text ID
`Minutes
`Day
`(size in kb)
`(size in kb)
`(size in kb)
`3737t1.rtf
`3737m1.pdf, html
`05/11 Pages 1-100
`3737t1_01.pdf
`
`Start
`05/11
`
`Pages 101-200
`3737t1_02.pdf
`
`Pages 201-300
`3737t1_03.pdf
`
`Pages 301-345
`3737t1_04.pdf
`
`[ Top ]
`
`Start
`09/10
`
`Transcript PDF ID
`(size in kb)
`Day
`09/10 Morning Session Pages
`1-100 3782t1_01a.pdf
`(10,008) Pages 101-179
`3782t1_01b.pdf
`
`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)
`
`Oncologic Drugs Advisory Committee
`Transcript Text ID
`Minutes
`(size in kb)
`(size in kb)
`Morning Session
`3782t1_01.htm (139)
`
`
`
`Afternoon Session
`3782t1_02.htm
`
`
`
`09/11 Pages 1-100
`3782t2_01.pdf Pages
`101-200 3782t2_02.pdf
`Pages 201-239
`3782t2_03.pdf
`
`3782t2.htm
`
`
`
`Other Docs ID
`(size in kb)
`Agenda
`3737a1.htm, pdf
`
`Planning Agenda
`3737a1_planning.htm,
`
`Questions
`3737q1.htm, pdf
`
`Briefing Information
`3737b1.htm
`Petition
`
`Other Docs ID
`(size in kb)
`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
`
`https://web.archive.org/web/20011004081740/http://www.fda.gov/ohrms/dockets/ac/cder01.htm
`
`7/11
`
`Wockhardt 1020
`
`
`
`5/13/2014
`
`06/28
`
`06/28 Pages 1-100
`3756t1_01.pdf
`
`CDER 2001 Advisory Committee Meeting Documents
`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
`
`3757t1.txt, htm
`
`
`
`Pages 101-201
`3757t1_02.pdf
`
`4/24
`
`4/24
`
`3743t1_01.pdf
`3743t1_02.pdf
`3743t1_03.pdf
`
`Pediatric Subcommittee
`3743t1.rtf
`
`
`[ Top ]
`
`Start
`
`Day
`
`6/6
`
`6/6
`
`Peripheral & Central Nervous System Drugs Advisory Committee
`Transcript PDF ID
`Transcript Text ID
`Minutes
`(size in kb)
`(size in kb)
`(size in kb)
`
`3754t1.txt
`
`3754m1.pdf, html
`
`Pages 1-100
`3754t1_01.pdf
`
`Pages 101-200
`3754t1_02.pdf
`
`Pages 201-300
`3754t1_03.pdf
`
`Pages 301-381
`3754t1_04.pdf
`
`https://web.archive.org/web/20011004081740/http://www.fda.gov/ohrms/dockets/ac/cder01.htm
`
`Agenda
`3756a1.htm, pdf
`
`Roster
`3756r1.htm, pdf
`
`Briefing Information htm
`
`Slides
`3756s1.htm
`Agenda
`3757a1.htm & pdf
`
`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
`
`Other Docs ID
`(size in kb)
`
`Agenda
`3754a1.pdf, html
`
`Rosters
`Members 3754r1_01.pdf,
`html
`
`Consultants
`3754r1_02.pdf, html
`
`Public Hearing
`3754r1_03.pdf, html
`
`Questions
`3754q1.pdf, html
`
`Briefing Information
`
`8/11
`
`Wockhardt 1020
`
`
`
`5/13/2014
`
`CDER 2001 Advisory Committee Meeting Documents
`
`3/13
`
`3/13
`
`3724t1.pdf
`
`3724t1.rtf
`
`3724m1.htm
`3742m1.pdf
`
`
`
`3/14
`
`3724t2.pdf
`
`3724t2.rtf
`
`3724m2.htm
`3724m2.pdf
`
`[ Top ]
`
`Advisory Committee for Pharmaceutical Science
`
`Briefing Information
`3754b1.htm
`
`Slides
`3754s1.htm
`Agenda
`3724a1.doc, pdf
`
`Roster
`3724r1_01.doc, pdf
`
`Briefing Info
`3724b1.htm
`
`Slides
`3724s1.htm
`Agenda (DRAFT)
`3724a2.doc, pdf
`
`Roster
`3724r1_02.doc, pdf
`
`Briefing Info
`3724b2.htm
`
`Slides
`3724s2.htm
`
`Transcript Text ID
`Transcript PDF ID
`(size in kb)
`(size in kb)
`Day
`Start
`07/19 07/19 Pages 1-100
`3763t1.htm, txt 3763m1.htm &
`3763t1_01.pdf
`
`Agenda
`3763a1.htm & pdf
`
`Minutes
`(size in kb)
`
`Other Docs ID
`(size in kb)
`
`Pages 101-200
`3763t1_02.pdf
`
`Pages 201-300
`3763t1_03.pdf
`
`Pages 301-313
`3763t1_04.pdf
`
`Roster
`3763r1.htm & pdf
`Guest Roster
`3763r1_guest.doc
`FDA Roster
`3763r1_fda.doc &
`
`Questions
`3763q2.htm &
`
`Briefing
`Information
`3763b1.htm
`
`Slides
`3763s1.htm
`https://web.archive.org/web/20011004081740/http://www.fda.gov/ohrms/dockets/ac/cder01.htm
`
`9/11
`
`Wockhardt 1020
`
`
`
`5/13/2014
`
`
`
`7/20 Pages 1-100
`3763t2_01.pdf
`
`Pages 101-171
`3763t2_02.pdf
`
`CDER 2001 Advisory Committee Meeting Documents
`3763s1.htm
`Agenda
`3763a2.htm & pdf
`
`3763t2.htm, txt 3763m2.htm &
`
`Guest Roster
`3763r2_guest.doc
`FDA Roster
`3763r2_fda.doc &
`
`Slides
`3763s2.htm
`Orally Inhaled and Nasal Drug Products Subcommittee
`7/17 Pages 1-100
`3764t1.htm, txt
`Agenda
`3764t1_01.pdf
`3764a1.htm & pdf
`
`7/17
`
`Pages 101-200
`3764t1_02.pdf
`
`Pages 201-211
`3764t1_03.pdf
`
`5/3
`
`5/3
`
`Non-Clinical Studies Subcommittee
`3742t1.pdf
`3742t1.rtf (93)&
`
`(10,036)
`html (100 )
`
`Roster
`3764r1.htm & pdf
`
`Open Speakers
`3764r1.htm & pdf
`
`Questions
`3764q1.htm &
`
`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
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`[ Top ]
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`Psychopharmacologic Drugs Advisory Committee
`Transcript PDF ID
`Transcript Text ID
`Minutes
`Start
`Day
`(size in kb)
`(size in kb)
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`https://web.archive.org/web/20011004081740/http://www.fda.gov/ohrms/dockets/ac/cder01.htm
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`Other Docs ID
`(size in kb)
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`10/11
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`Wockhardt 1020
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`
`
`5/13/2014
`Start
`2/14
`
`Day
`2/14
`
`(size in kb)
`3685t1.pdf
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`CDER 2001 Advisory Committee Meeting Documents
`(size in kb)
`(size in kb)
`3685t1.txt
`3685m1.pdf
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`
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`2/15
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`3685t2.pdf
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`3685t2.txt
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`3685m2.pdf
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`[ Top ]
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`Start
`05/11
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`Pulmonary-Allergy Drugs Advisory Committee
`Transcript PDF ID
`Transcript Text ID
`Minutes
`(size in kb)
`Day
`(size in kb)
`(size in kb)
`05/11 Pages 1-100
`3737t1.rtf
`3737m1.pdf, html
`3737t1_01.pdf
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`Pages 101-200
`3737t1_02.pdf
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`Pages 201-300
`3737t1_03.pdf
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`Pages 301-345
`3737t1_04.pdf
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` [ Top ]
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`(Updated 10/02/01 )
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`(size in kb)
`Agenda
`3685a1.doc, pdf
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`Roster
`3685r1.doc, pdf
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`Questions
`3685q1.doc, pdf
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`Briefing Info
`3685b1.htm
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`Slides
`3685s1.htm
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`Agenda
`3685a2.doc, pdf
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`Roster
`3685r2.doc, pdf
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`Questions
`3685q2.doc, pdf
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`Briefing Info
`3685b2.htm
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`Slides
`3685s2.htm
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`Other Docs ID
`(size in kb)
`Agenda
`3737a1.htm, pdf
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`Planning Agenda
`3737a1_planning.htm,
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`Questions
`3737q1.htm, pdf
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`Briefing Information
`3737b1.htm
`Petition
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`https://web.archive.org/web/20011004081740/http://www.fda.gov/ohrms/dockets/ac/cder01.htm
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`11/11
`
`Wockhardt 1020