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CDER 2001 Meeting Documents

Anesthetic and Life Support Drugs Advisory Committee

Start Day Transcript PDF ID
(size in kb)
Transcript Text ID
(size in kb)
Minutes
(size in kb)
Other Docs ID
(size in kb)
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. Draft Agenda
3778a1_draft.pdf

Questions
3778q1.pdf

Meeting Info
m000001.pdf, htm

Briefing Information  3778b1.htm

Docket Number 01N-0256

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Anti-Infective Drugs Advisory Committee

Start Day Transcript PDF ID
(size in kb)
Transcript Text ID
(size in kb)
Minutes
(size in kb)
Other Docs ID
(size in kb)
11/07 11/07 Pages 1-100 (8,448)

Pages 101-200  (8,549)

Pages 201-307  (17,286)

[Word version] [htm version] [pdf version] [htm version] [Word version] Final Agenda [Word version]  [pdf version] [htm version]

Draft Agenda [Word version] [pdf version] [htm version]

Questions [Word version] [pdf version] [htm version]

Briefing Information htm

Slides

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

3797t1.[Word Version] (477) & [HTML Version] (394)    Agenda   htm  &   pdf

Questions   htm  &  pdf

Briefing Information

Roster 
Committee Members   htm   &   pdf

Slides   3797s1.htm

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_01.pdf
(10,540)

Pages 101-200
3746t1_02.pdf
(10,646)

Pages 201-339
3746t1_03.pdf
(19,170)

3746t1.rtf (388) & html (392) pdf   htm   doc Agenda
3746a1.pdf, htm

Briefing Info.
3746b1.htm

Roster
3746r1_01committee.pdf, htm
3746r1_02guest.pdf, htm

Slides
3746s1.htm

Questions
pdf   htm  doc

04/23 04/23 3744t1_01.pdf & htm 3744t1.rtf   Notice of Mtg.
032301d.htm & pdf

Briefing Information
3744b1.htm

Agenda
3744a1.pdf, htm

Roster
3744r1.pdf, htm

Questions
3744q1.pdf, htm

Slides
3744s1.pdf

  04/24 3744t2.pdf & htm 3744t2.rtf   Briefing Information
3744b2.htm

Agenda
3744a2.pdf, htm

Roster
3744r2.pdf, htm

Questions
3744q2.pdf, htm

Slides
3744s2.htm

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 Briefing Package
3719b1.htm

Roster
3719r1.htm

Slides
3719s1.htm

Agenda
3719a1.htm

Question
3719q1.htm

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Anti-Viral Drugs Advisory Committee

Start Day Transcript PDF ID
(size in kb)
Transcript Text ID
(size in kb)
Minutes
(size in kb)
Other Docs ID
(size in kb)
12/12 12/12 Pages 1-100

Pages 101-200

Pages 201-211

doc   htm   Notice of Meeting [text] [pdf]

Draft Agenda [pdf] [htm] [Word]

Final Agenda [pdf] [htm] [Word]

Questions  [pdf] [htm] [Word]

Roster  
Committee  [pdf] [htm] [Word
Consultants & Guests [pdf] [htm] [Word]

Briefing Information 

Slides

10/03 10/03 Pages 1 - 100 pdf (9,207)

Pages 101-200 pdf (9,581)

Pages 201-300 pdf (10,067)

Pages 301-326 04.pdf (8,207)

htm  

Draft Agenda [pdf] [htm]

Final Agenda [pdf] [htm]

Roster
Committee [pdf] [htm] Consultants & Guests  [pdf] [htm]

Questions pdf

Briefing Information 

Slides  

  10/04 Pages 1 - 100 pdf (9,357)

Pages 101-200 pdf (9,375)

Pages 201-300 pdf (9,990)

Pages 301-327 pdf (8,452)

htm   Agenda pdf  &  htm

Roster
Committee pdf & htm Consultants & Guests  pdf 

Questions pdf

Briefing Information  htm

Slides htm

02/27 02/27 3731t1_01.pdf (6394)
3731t1_02.pdf (6275)
3731t1_03.pdf (3920)
rtf (271)   Agenda
doc, pdf

Slides
htm

Roster
Part 1 doc, pdf
Part 2doc, pdf

Briefing Information
htm

Questions
doc, pdf

01/10 01/10 3676t1_a.pdf
3676t1_b.pdf
3676t1_c.pdf
3676t1_d.pdf
rtf   Agenda
doc, pdf

Roster
doc, pdf

Briefing Information
htm

Slides
htm

  01/11 3678t1_a.pdf
3678t1_b.pdf
3678t1_c.pdf
3678t1_d.pdf
rtf   Agenda
doc, pdf

Briefing Information
htm

Slides
htm

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Arthritis Advisory Committee
Start Day Transcript PDF ID
(size in kb)
Transcript Text ID
(size in kb)
Minutes
(size in kb)
Other Docs ID
(size in kb)
12/07 12/07       Closed Meeting
08/16 08/16 3779t1.pdf (320)     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

Slides
3779s1.htm

  08/17 Pages 1-100
3779t2_01.pdf

Pages 101-159
3779t2_02.pdf

  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

04/19 04/19 3740t1_01.pdf
3740t1_02.pdf
3740t1_03.pdf
3740t1.rtf   Agenda
3740a1.htm & pdf

Briefing Information
3740b1.htm

Questions
3740q1.htm & pdf

Roster
3740r1_01 htm & pdf
3740r1_02 htm & pdf

Slides
3740s1.htm

02/07 02/07 3677t1_01.pdf (6421)
3677t1_02.pdf (6733)
3677t1_03.pdf (2448)
3677t1.rtf (561)   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

  02/08 3677t2_01.pdf (6774)
3677t2_02.pdf (6852)
3677t2_03.pdf (2918)
3677t2.rtf (597)   Briefing Package
3677b2.htm

Agenda
3677a2.doc & pdf

Questions
3677q2_01.doc & pdf
3677q2_02.doc & pdf

Slides
3677s2.htm

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Cardiovascular and Renal Drugs Advisory Committee

Start Day Transcript PDF ID
(size in kb)
Transcript Text ID
(size in kb)
Minutes
(size in kb)
Other Docs ID
(size in kb)
10/11 10/11 Morning Session
Pages 1-100 pdf

Pages 101-129 pdf
Afternoon Session
Pages 130-229 pdf

Pages 230-274 pdf

[Word] [htm]     Agenda
3793a1.htm  &  pdf

Briefing Information   

Questions 3793q1.htm  &  pdf

Slides 3793s1.htm

08/09 08/09 Pages 1-100
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

3775t1.rtf (444)      Agenda
3775a1.htmpdf

Roster
3775r1.htm

Briefing Information
3775b1.htm

Questions
Remondulin
3775q1_01.pdf,   htm

Extraneal
3775q1_02.pdf,   htm

Slides
3775s1.htm

  08/10 Pages 1-100 3775t2_01.pdf

Pages 101-200 3775t2_02.pdf

Pages 201-228 3775t2_03.pdf

3775t2.rtf (299)   Briefing Information
3775b2.htm

Questions
bosenton
3775q2.pdf,   htm

5/24 5/24 3749t1_01.pdf (9171)
3749t1_02.pdf (8690)
3749t1_03.pdf (7469)
3749t1_04.pdf (4025)
3749t1.rtf (437)   Briefing Information
3749b1.htm

Agenda
3749a1.pdf & htm

Questions
3749q1.pdf & htm

  5/25 3749t2_01.pdf (9171)
3749t2_02.pdf (8465)
3749t2_03.pdf (8352)
3749t2_04.pdf (7345)
3749t2.rtf (465)   Briefing Information
3749b2.htm

Questions
3749q2.pdf & htm

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Endocrinologic and Metabolic Drugs Advisory Committee

Start Day Transcript PDF ID
(size in kb)
Transcript Text ID
(size in kb)
Minutes
(size in kb)
Other Docs ID
(size in kb)
07/26 07/26 Pages 1-100
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)

3761t1.htm 3761m1.pdf  &  htm Notice of Meeting
June 8, 2001 txt   pdf

Agenda
3761a1.pdf,   htm

Questions
3761q1.pdf,   htm

Briefing Information
3761b1.htm

Slides
3761s1.htm

  07/27 Pages 1-100
3761t2_01.pdf (8,398)

Pages 101-200
3761t2_02.pdf (8,508)

Pages 201-300
3761t2_03.pdf (8,318)

Pages 301-359
3761t2_04.pdf (9,991)

3761t2.htm 3761m2.pdf  &  htm

Agenda
3761a2.pdf,   htm

Questions
3761q2.pdf,   htm

Roster
3761r2.pdf,   htm

Briefing Information
3761b2.htm

Slides
3761t2.htm

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Nonprescription Drugs Advisory Committee

Start Day Transcript PDF ID
(size in kb)
Transcript Text ID
(size in kb)
Minutes
(size in kb)
Other Docs ID
(size in kb)

Joint meeting with Pulmonary-Allergy Drugs Advisory Committee

05/11 05/11 Pages 1-100
3737t1_01.pdf

Pages 101-200
3737t1_02.pdf

Pages 201-300
3737t1_03.pdf

Pages 301-345
3737t1_04.pdf

3737t1.rtf 3737m1.pdf, html Agenda
3737a1.htm, pdf

Planning Agenda
3737a1_planning.htm, pdf

Questions
3737q1.htmpdf

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

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Oncologic Drugs Advisory Committee

Start Day Transcript PDF ID
(size in kb)
Transcript Text ID
(size in kb)
Minutes
(size in kb)
Other Docs ID
(size in kb)
12/05 12/05 Pages 1-100

Pages 101-200

Pages 201-300

Pages 301-362

rtf   Draft Agenda 3815a1 [pdf version] [htm version] [Word version]

Briefing Information
Morning Session 3815b1_01.htm

Afternoon Session
3815b1_02.htm

Slides

  12/06 Pages 1-100

Pages 101-200

Pages 201-300

Pages 301-397

rtf   Briefing Information
Morning Session 3815b2_01.htm

Afternoon Session 3815b2_02.htm

Slides

Pediatric Subcommittee

11/28 11/28 Morning Session 
Pages 1-100 pdf

Pages 101-202  pdf
Afternoon Session
Pages 203-302 pdf

Pages 303-405 pdf

[Word] [htm]   Draft Agenda 3803a1.[Word version] [htm version] [pdf version]

Roster 3803r1.[Word version] [htm version] [pdf version]

Questions 3803q1. [Word version] [htm version] [pdf version]

Briefing Information 3803b1.htm

Slides 3803s1.htm

09/10 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)

Morning Session 3782t1_01.htm (139)  

Afternoon Session 3782t1_02.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. pdfhtm

Briefing Information
3782b1.htm

Slides  3782s1.htm

  09/11 Pages 1-100  3782t2_01.pdf  Pages 101-200  3782t2_02.pdf  Pages 201-239 3782t2_03.pdf 3782t2.htm   Briefing Information
3782b2.htm

Questions  3782q2_zevalin.pdf  &  htm

Slides 3782s2.htm

Pediatric Subcommittee

06/28 06/28 Pages 1-100
3756t1_01.pdf

Pages 101-200
3756t1_02.pdf

Pages 201-end
3756t1_03.pdf

3756t1.rtf, 3756t1.txt   Agenda
3756a1.htm, pdf

Roster
3756r1.htm, pdf

Briefing Information htm & pdf

Slides
3756s1.htm

06/07 06/07 Pages 1-100
3757t1_01.pdf

Pages 101-201
3757t1_02.pdf

3757t1.txthtm   Agenda
3757a1.htm & pdf

Questions
3757q1.htm & pdf

Briefing Information
3757b1.htm & pdf

Pediatric Subcommittee

4/24 4/24 3743t1_01.pdf
3743t1_02.pdf
3743t1_03.pdf
3743t1.rtf   Agenda
3743a1.htm & pdf

Roster
3743r1.htm, pdf

Briefing Information
3743b1.htm & pdf

Slides
3743s1.htm

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Peripheral & Central Nervous System Drugs Advisory Committee
Start Day Transcript PDF ID
(size in kb)
Transcript Text ID
(size in kb)
Minutes
(size in kb)
Other Docs ID
(size in kb)
6/6 6/6 Pages 1-100
3754t1_01.pdf

Pages 101-200
3754t1_02.pdf

Pages 201-300
3754t1_03.pdf

Pages 301-381
3754t1_04.pdf

3754t1.txt 3754m1.pdf, html 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
3754b1.htm

Slides
3754s1.htm

3/13 3/13 3724t1.pdf 3724t1.rtf 3724m1.htm
3742m1.pdf
Agenda
3724a1.doc, pdf

Roster
3724r1_01.doc, pdf

Briefing Info
3724b1.htm

Slides
3724s1.htm

  3/14 3724t2.pdf 3724t2.rtf 3724m2.htm
3724m2.pdf
Agenda (DRAFT)
3724a2.doc, pdf

Roster
3724r1_02.doc, pdf

Briefing Info
3724b2.htm

Slides
3724s2.htm

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Advisory Committee for Pharmaceutical Science
Start Day Transcript PDF ID
(size in kb)
Transcript Text ID
(size in kb)
Minutes
(size in kb)
Other Docs ID
(size in kb)
11/28 11/28 Morning Session
Pages 1-100 

Pages 101-143

Afternoon Session
Pages 144-243

Pages 244-282

[Word] [htm]   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

  11/29 Morning Session
Pages 1-100

Pages 101-141

Afternoon Session
Pages 142-243

Pages 244-294

[Word] [htm]   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 3804b2.htm

Slides

Nonclinical Studies Subcommittee

11/13 11/13 Pages 1-100 (10,038)

Pages 101-148 
(6,901)

[htm version] [Word version] [pdf]  [htm]  [Word] Draft Agenda 3798a1. [htm format] &  [pdf format]

Roster  Committee Members  
[htm format]  & [pdf format]
Guests 
[htm format]  &  [pdf format]

Briefing Information 3798b1.htm

07/19 07/19 Pages 1-100
3763t1_01.pdf

Pages 101-200
3763t1_02.pdf

Pages 201-300
3763t1_03.pdf

Pages 301-313
3763t1_04.pdf

3763t1.htm, txt 3763m1.htm & pdf Agenda
3763a1.htm & pdf

Roster
3763r1.htm & pdf
Guest Roster
3763r1_guest.doc & pdf
FDA Roster
3763r1_fda.doc & pdf

Questions
3763q2.htm & pdf 

Briefing Information
3763b1.htm

Slides
3763s1.htm

  7/20 Pages 1-100
3763t2_01.pdf

Pages 101-171
3763t2_02.pdf

3763t2.htmtxt 3763m2.htm & pdf Agenda
3763a2.htm & pdf

Guest Roster
3763r2_guest.doc & pdf
FDA Roster
3763r2_fda.doc & pdf

Slides
3763s2.htm

Orally Inhaled and Nasal Drug Products Subcommittee

7/17 7/17 Pages 1-100
3764t1_01.pdf

Pages 101-200
3764t1_02.pdf

Pages 201-211
3764t1_03.pdf

3764t1.htm,   txt 3764m1.htm  &   pdf Agenda
3764a1.htm & pdf

Roster
3764r1.htm & pdf

Open Speakers
3764r1.htm & pdf

Questions
3764q1.htm & pdf 

Briefing Information
3764b1.htm

Slides
3764s1.htm

Non-Clinical Studies Subcommittee

5/3 5/3 3742t1.pdf
(10,036)
3742t1.rtf (93)& html (100 )   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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Psychopharmacologic Drugs Advisory Committee
Start Day Transcript PDF ID
(size in kb)
Transcript Text ID
(size in kb)
Minutes
(size in kb)
Other Docs ID
(size in kb)
2/14 2/14 3685t1.pdf

3685t1.txt 3685m1.pdf Agenda
3685a1.doc, pdf

Roster
3685r1.doc, pdf

Questions
3685q1.doc, pdf

Briefing Info
3685b1.htm  

Slides
3685s1.htm

  2/15 3685t2.pdf 3685t2.txt 3685m2.pdf Agenda
3685a2.doc, pdf

Roster
3685r2.doc, pdf

Questions
3685q2.doc, pdf

Briefing Info
3685b2.htm

Slides
3685s2.htm

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Pulmonary-Allergy Drugs Advisory Committee
Start Day Transcript PDF ID
(size in kb)
Transcript Text ID
(size in kb)
Minutes
(size in kb)
Other Docs ID
(size in kb)

Joint meeting with Nonprescription Drugs Advisory Committee

05/11 05/11 Pages 1-100
3737t1_01.pdf

Pages 101-200
3737t1_02.pdf

Pages 201-300
3737t1_03.pdf

Pages 301-345
3737t1_04.pdf

 
3737t1.rtf 3737m1.pdf, html Agenda
3737a1.htm, pdf

Planning Agenda
3737a1_planning.htm, pdf

Questions
3737q1.htmpdf

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

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Page updated: March 27, 2007