`
`Advisory Committees: CD ER 2001 Meeting Documents
`
`
`
`FDA Home Page | Dockets Home Page | Dockets Contacts and Location |Ogerating Status | Federal Register
`
`Q9 |AC Home Page
`CDER 2001 Meeting Documents
`
`Anesthetic and Life Su ' ort Dru s Adviso Committee
`
`
`Anti-Infective Drugs Advisory Committee
`Anti—Viral Drug 5 Advisory Committee
`Arthritis Advisory Committee
`Cardiovascular and Renal Drugs Advisory Committee
`Endocrinolo ic and Metabolic Dru s Adviso Committee
`
`Non rescri 'tion Dru sAdviso Committee
`
`Oncolvo, ic Dru sAdviso: Committee
`
`Pen' heral and Central Nervous S stem Dru sAdviso Committee
`
`Adviso Committee for Pharmaceutical Science
`
`Ps cho harmacolo ic Dru sAdviso Committee
`
`Pulmona —Aller
`D
`sAdviso Comm'ttee
`
`
`'
`
`Start Day
`
`Anesthetic and Life Support Drugs Advisory Committee
`Transcript PDF
`ID
`(size in kb)
`
`Transcript Text ID
`(size in kb)
`
`Minutes
`(size in kb)
`
`Other Docs ID
`(size in kb)
`
`0256
`
`9/13
`
`9/14 Due to the events of this week, this meeting has been Draft Agenda
`postponed.
`It will be rescheduled in the future. This
`3778a1_draft.p_df
`meeting has been rescheduled for January 30—31,
`.
`.
`.
`.
`Questions
`2002. You may find additional Information mm 3778mm
`2002 page.
`
`Meeting Info
`m000001.m, 1m
`
`Briefing Information
`3778b1.htm
`
`Docket Number O1N-
`
`Anti-lnfective Irug 3 Advisory Committee
`
`rfi
`
`iv 1
`
`>1
`
`.Tq‘“.
`
`
`
`
`|Word version]
`|htm version]
`
`11/07 11107 Pages 1-100
`(8,448)
`
`|p’dfversion] [ht_m FinaIAgenda |\_/\_lord
`version] |Word
`version] lp'df version]
`
`http://vwvw.fda.g ov/ohrms/dockets/ac/cderO1 .htm#Peri pheral %20&%20C entral%2ONervous
`
`1/16
`
`PAR1027
`
`CBM of US. Patent No. 7,668,730
`Page 1 of 16
`
`
`
`Page 1 of 16
`
`
`
`7/2/2014
`
`Pages 101-200
`(8,549)
`
`Pages 201-307
`(17,285)
`
`Advisory Committees: CD ER 2001 Meeting Documents
`
`version]
`
`|htm version]
`
`Draft Agenda [M
`version| |gdf version|
`[htm version]
`
`Questions [M
`version| |pdf version|
`[htm version]
`
`Briefing Information
`htm
`
`Slides
`
`3797t1.|V_Vord
`10/16 10I16 Pages 1-100
`3797t1 01.pdf Version|(477)
`& [HTML
`,
`VerSIon|(394)
`‘
`
`Pages 101-200
`3797“ 02. df
`E
`
`Pages 201-300
`3797t1 03.9df
`
`Pages 301-345
`
`Agenda m & pgf
`_
`ht_m & p_df
`Questions
`.
`.
`.
`Briefin Information
`_Q—
`Roster
`Committee Members
`
`htm & M
`
`Slides 3797s1.htm
`
`Summary Minutes
`
`It
`09/12 09/12 Due to the events of this week, this meeting has been postponed.
`will be rescheduled in the future. Please check here for the new date.
`
`‘
`
`This meeting was rescheduled for 10/16/01.
`
`3797t1 04.9df
`
`
`04/26 04/26 Pages 1- 100
`3746t1_01.]mc
`(10,540)
`
`Pages 101-200
`3746t1_02.m_f
`(10,646)
`
`Pages 201-339
`374611_03.M
`(19,170)
`
`.
`
`3746t1 m (388) M htm M
`& htmi (392)
`
`3746a14fl‘, ht_m
`
`Briefing Info.
`
`3746b1.ht_m
`
`.
`Roster
`3746r1_01committee.p_df,
`
`ht_m
`3746r1_029uest.mfl, ht_m
`.Slides
`374651L
`
`Questions
`
`mi hm m
`
`04/23 04/23 3744t1_01.p_df & 3744t1.fl
`ht_m
`
`http://iANiAN.fda.g ov/ohrms/dockets/ac/cderO1 .htm#Peri pheral %20&%20C entral%20Nervous
`
`Notice of Mtg.
`032301 d.ht_m & p_df
`
`Briefing Information
`3744b1.ht_m
`
`Agenda
`3744a1.mf, ht_m
`
`Roster
`
`2/16
`
`PAR1027
`
`CBM of US. Patent No. 7,668,730
`Page 2 of 16
`
`
`
`Page 2 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`3744r1.pfl‘, htm
`
`Questions
`
`3744q1-itflf, ht_m
`
`Slides
`
`374431.]M
`
`04/24 3744t2.pg‘&ht_m 3744t2m
`
`Briefing Information
`3744b2.ht_m
`
`Agenda
`3744a2.p_df, ht_m
`
`Roster
`
`3744mm, ht_m
`
`Questions
`
`3744q2.mf, ht_m
`
`Slides
`
`374452.ht_m
`
`01/30 01/30 3719t1 01.pdf
`(6126)
`3719t1 02. df
`(6374)
`371911 03. df
`
`3719t1.fl(439) 3719m1.m,p_df Briefing Package
`3719b1.htm
`R t
`OS er
`—3719”'mm
`
`
`
` ‘
`
`(6385)
`3719t1 04. df
`
`(6428)
`
`Slides
`Mm.
`
`Agenda
`3719a1.ht
`
`Question
`
`[3.10.1
`
`IT.‘ Pages 1-100
`
`l:
`
`Pages 101-200
`
`Pages 201-211
`
`http://iAMAN.fda.g ov/ohrms/dockets/ac/cdero1 .htm#Peri pheral %20&%20C entral%20Nervous
`
`Notice of Meeting
`[te—Xt] [p_df]
`Draft Agenda [M]
`[ht_m] [Word]
`
`Final Agenda [M]
`{ht_m} [Md]
`
`Questions [MI [ht_m]
`[W0 rd |
`
`Roster
`
`Committee [M]
`
`3/16
`
`PAR1 027
`
`CBM of US. Patent No. 7,668,730
`Page 3 of 16
`
`
`
`Page 3 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CD ER 2001 Meeting Documents
`
`[ht_m] [_W0rd]
`Consultants &
`
`Guests [m {ht_m}
`[W0 rd |
`
`Briefing Information
`
`M D
`
`raft Agenda [m
`[htm|
`
`1cv03
`
`10/03 Pages 1 — 100 Ldf
`(9207)
`
`ht_m
`
`Pages 101-200 Ldf
`(9,581)
`
`Pages 201-300 m
`(10,067)
`
`Pages 301-326 O4.pdf
`(8,207)
`
`10/04 Pages 1 - 100 p_df
`61357)
`
`Pages 101-200 p_df
`(9,375)
`
`Pages 201-300 pgf
`(9,990)
`
`Pages 301-327 pgf
`(8,452)
`
`
`
`ht_m
`
`a--
`
`$971)
`
`Final Agenda [p_df]
`[ht—"1]
`
`Roster
`
`Committee [MI [ht_m]
`Consultants &
`
`Guests [M] [ht_m]
`
`Questions M
`
`Briefing Information
`
`Slides
`
`Agenda p_df &
`nun
`
`Roster
`
`Committee M & ht_m
`Consultants &
`
`Guests fl
`
`Questions M
`
`Briefing Information
`ht_m
`
`
`
`Slides ht_m
`
`Agenda
`090,29:
`
`Slides
`
`ht_m
`
`Roster
`
`Part 1 CM, M
`Part 2M, at
`
`Briefing Information
`ht_m
`
`Questions
`
`M, M
`
`Agenda
`099,29:
`
`Roster
`
`4/16
`
`PAR1027
`
`CBM of US. Patent No. 7,668,730
`Page 4 of 16
`
`02/27 02/27 3731t1 01.pdf
`(6394)
`3731n 02.01
`
`(6275)
`373111 03pdf
`(3920)
`
`01/10 O1/103676t1 a.pdf
`3676t1 bpdf
`3676t1 def
`3676t1 dpdf
`
`http://uMANfdag ov/ohrms/dockets/ac/cderO1 .htm#Peri pheral %20&%20C entral%2ONervous
`
`
`
`Page 4 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CD ER 2001 Meeting Documents
`
`mm
`
`Briefing Information
`ht_m
`
`Slides
`
`01/11 3678t1_a.pg‘
`3678t1_b.p_df
`367811_c.m
`3678t1_d.p_ch‘
`
`
`
`Closed Meeting
`
`Agenda
`3779a1.ht_m & Mt
`
`Rosters
`Committee
`
`3779r1_committee.ht_m & M
`
`Consultants
`
`3779r1_consultants.ht_m & mf
`
`Public Hearing
`3779r1_public_hearing.m_m &
`
`m B
`
`riefing Information
`3779b1.ntfl
`
`Questions
`
`3779q1.ht_m & mf
`
`Revised Questions
`
`3779q1_revised.ht_m & @
`
`Slides
`377951htm
`
`08/17 Pages 1-100
`3779t2 01.pdf
`
`Pages 101-159
`3779t2 02.pdf
`
`3779m2.p_df
`& ht_m
`
`Agenda
`3779a2.ht_m & pfl‘
`
`Rosters
`Committee
`
`3779r2_committee.ht_m & pg‘
`
`http://uMAN.fda.g ov/ohrms/dockets/ac/cderO1 .htm#Peri pheral %20&%20C entral%20Nervous
`
`5/16
`
`PAR1027
`
`CBM of US. Patent No. 7,668,730
`Page 5 of 16
`
`
`
`Page 5 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CD ER 2001 Meeting Documents
`
`Consultants
`
`3779r2_consultants.m_m & m:
`
`Public Hearing
`3779r1_public_hearing.m_m &
`
`m B
`
`riefing Information
`3779b2.ht_m
`
`Agenda
`3740a1 .ht_m & plf
`
`Briefing Information
`3740b1.ht_m
`
`Questions
`
`3740q1.ht_m & p_df
`
`Roster
`
`3740r1_01 ht_m & M
`3740r1_02 ht_m & p_df
`
`Slides
`374051,.htm
`
`Agenda
`3677a1.m, p_df
`
`Roster
`
`3677r1_01.fl, 01f
`
`Guest Roster
`
`3677r1_02.@, pgf
`
`Briefing Information
`3677b1.ht_m
`
`04/19 04/19 374011_01 pg
`374011324311
`3740t1_03.M
`
`3677t1.rtf(561)
`
`02/07 02/07 3677t1_01.m_f
`(6421)
`3677t1_02.m
`(6733)
`3677t1_03.pdf
`(2448)
`
`3677s2.ht
`
`Questions
`
`3677q1 .M, M
`
`Slides
`
`3677s1.fit_m
`
`Briefing Package
`3677b2.htm
`
`Agenda
`36‘77a2.doc & FM
`
`Questions
`
`367792 01.doc & w
`367792 02.doc & p_df
`
`Slides
`
`3677t2.rtf(597)
`
`02/08 3677t2 01. df
`(6774)
`3677t2 02. df
`
`(6852)
`3677t2 03. df
`
`(2918)
`
`
`
`mm
`
`http://vwvw.fda.g ov/ohrms/dockets/ac/cdero1 .htm#Peri pheral %20&%20C entral%20Nervous
`
`Cardiovascular and Renal Drugs Advisory Committee
`
`6/16
`
`PAR1027
`
`CBM of US. Patent No. 7,668,730
`Page 6 of 16
`
`
`
`Page 6 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CD ER 2001 Meeting Documents
`
`10/11
`
`0/11 Morning Session
`Pa'es1-1OO df
`
`Pa es 101-129 df
`Afternoon Session
`Pa es 130-229 df
`
`Pa es 230-274 df
`
`08/09 08/09 Pages 1-100
`3775t1 01 . df
`
`
`
`
`
`Pages 101-200
`775M 02. df
`
`Pages 201-300
`3775t1 03. df
`
`Pages 301-400
`3775t1 O4. df
`
`Pages 401-411
`3775t1 05. df
`
`5/24
`
`08/10 Pages 1-100
`3775t2 O1.
`cIf
`
`Pages 101-200
`3775t2 02. df
`
`Pages 201-228
`3775t2 03. df
`
`5/24 3749t1_01.pflc
`(91 71)
`3749t1_02.m‘
`(8690)
`3749t1_03.p_dj
`(7469)
`3749t1_04.p_df
`(4025)
`
`3775t1 .rtf (444)
`
`3775t2.rtf (299)
`
`3749t1 m (437)
`
`Agenda
`3793a1.ht_m & pgf
`
`Questions
`
`3793q1.ht_m & mf
`
`Slides 379351.htm
`
`Agenda
`3775a1.htm, M
`
`Roster
`3775r1.htm
`
`Briefing Information
`3775b1.htm
`
`Questions
`Remondulin
`
`3775q1_01.pgf,
`
`ht_m
`
`Extraneal
`
`3775q1_02.pgf,
`
`ht_m
`
`Slides
`37‘75s1.htm
`
` Briefing Information
`
`Briefing Information
`3775b2.htm
`
`Questions
`bosenton
`
`37750I2-.D_df.
`
`ht_m
`
`Briefing Information
`3749b1.ht_m
`
`Agenda
`3749a1 .‘rfl8‘ ht_m
`
`Questions
`
`3749q1.;fif & ht_m
`
`3749t2.m(465)
`
`5/25 3749t2_01.;m
`(9171)
`3749t2_02.p_ch‘
`<8465>
`3749t2_03.p_d_f
`(8352)
`3749t2_04.p_df
`http://uNiAN.fda.g ov/ohrms/dockets/ac/cderO1 .htm#Peri pheral %20&%20C entra|%2ONervous
`
`Briefing Information
`3749b2.ht_m
`_
`3:555":me
`q "D— —
`
`7/16
`
`PAR1027
`
`CBM of US. Patent No. 7,668,730
`Page 7 of 16
`
`
`
`Page 7 of 16
`
`
`
`7/2/2014
`
`‘
`
`[£13.]
`
`Advisory Committees: CD ER 2001 Meeting Documents
`
`‘
`
`‘(7345)
`
`I
`
`‘
`
`‘
`
`\
`
`Endocfinologic and Metabolic Drugs Advisory Committee
`
`wg
`
`w
`
`:’n‘
`
`3761t1.htm
`
`3761mm &
`ht_m
`
`Notice of Meeting
`June 8, 2001 m
`
`'i
`
`07/26 07
`
`/26 Pages 1-100
`376111 01.pgf
`(9,446)
`
`Pages 101-200
`3761t1 02.9df (9,613)
`
`Pages 201-300
`3761t1 03.9df (9,586)
`
`Pages 301-342
`3761t1 04.9df (8,306)
`
`Nonprescription Drugs Advisory Committee
`
`Joint meeting with Pulmonam-Allergy Drugs Advisom Committee
`
`05/11
`
`05/11 Pages 1-100
`3737t1 01. df
`i
`
`373711.fl
`
`3737m1.p_df. m Agenda
`3737a1.ht_m,p_df
`
`Planning Agenda
`3737a1_p|anning.ht_m,
`p_df
`
`Questions
`
`8/16
`
`PAR1027
`
`CBM of US. Patent No. 7,668,730
`Page 8 of 16
`
`Pages 101-200
`373711 02. df
`
`i P
`
`ages 201-300
`3737t1 03. dfi
`
`http://uMAN.fda.g ov/ohrms/dockets/ac/cdero1 .htm#Peri pheral %20&%20C entra|%2ONervous
`
`
`
`htm
`
`m A
`
`genda
`3761a1£flf
`
`Questions
`
`3761q1£fii
`
`ht
`
`Briefing Information
`3761b1.ht_m
`
`Slides
`3761 s1 .htm
`
`Agenda
`3761 a2. M:
`
`ht_m
`
`Questions
`
`3761q2-M, m
`
`Roster
`
`3761 r2. pgf,
`
`ht_m
`
`Briefing Information
`3761 b2.ht_m
`
`Slides
`376112.ht
`
`07/27 Pages 1-100
`3761t2 01. df
`
`(8,398)
`
`3761t2.htm
`
`3761m2.pg,f &
`ht_m
`
`Pages 101-200
`376112 02.9df (8,508)
`
`Pages 201-300
`3761t2 03.9df(8,318)
`
`Pages 301-359
`376112 O4.gdf(9,991)
`
`
`
`Page 8 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CD ER 2001 Meeting Documents
`
`Pages 301-345
`3‘7§7t1 04.|gdf
`
`3737q1.flm, p_df
`
`Roster
`Consultants
`
`3737r1_01.ht+m & m
`
`Members
`
`3737r1_02.ht_m & M
`
`Open Public Hearing
`3737r1_03.ht_m & pgf
`
`Briefing Information
`3737b1.htm
`Petition
`
`Slides 373751.htm
`
`Open Public Hearing
`Presentations
`37370 o1.h’[m
`
`Oncologic Drugs Advisory Committee
`1
`., f“
`
`
`
`"Li?3:
`
`m
`
`, t 7w"
`
`12/05 12/05 Pages 1-10
`'
`-
`P
`101200
`4—8es
`Pages 201-300
`
`Pages 301-362
`
`m
`
`12/06 Pages 1-100
`
`fl
`
`M
`
`W
`
`Pages 301_397
`
`9.1”
`
`,
`
`Draft Agenda
`F
`3815a1 lpdfversion]
`|htm verSIon] |Word
`version]
`
`Briefing Information
`Morning Session
`3815b1 O1.ht
`
`Afternoon Session
`38 5
`0/.
`
`Slides
`
`Briefing Information
`Morning Session
`3815b2 01.,htm
`
`Afternoon Session
`
`3815b2 02.htm
`
`Slides
`
`Pediatric Subcommittee
`
`11/28 1 1/28 Morning Session
`Pages 1-100 pdf
`
`|Word] |htm|
`
`Pages 101—202
`
`Draft Agenda
`3803a1.|y\_/ord
`m] [Maw]
`mm version]
`
`http://uMANfdag ov/ohrms/dockets/ac/cdero1 .htm#Peri pheral %20&%20C entral%2ONervous
`
`9/16
`
`PAR1027
`
`CBM of US. Patent No. 7,668,730
`Page 9 of 16
`
`
`
`Page 9 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CD ER 2001 Meeting Documents
`
`p_clf
`Afternoon Session
`Pages 203—302
`4011‘
`
`Pages 303-405 pdf
`
`09/10 09/10 Morning Session Morning Session
`Pages 1—100
`3782t1 01.htm
`3782t1 01a.pdf
`(139)
`(10,008) Pages
`Afternoon Session
`101-179
`
`3782t1 01b. df —-—3782“0mm
`
`Afternoon Session
`pages 1-100
`378211 023_ df
`(9796) Pages 101-
`200 3782t1 02b.gdf
`(9,878)
`Pages 201-225
`3782t1 02c. df
`(2226)
`
`Roster 3803r1.[m
`—°—V3rsl”1 l—hlmVersmnl [91"
`m}
`Questions 3803q1. [Word
`version] [htm version] [p_df
`version]
`
`Briefing Information
`3803b1.htm
`
`Slides 38'0351.htm
`
`Agenda
`3782a1 -IL1I& ht_m
`Revised Agenda
`3782a1_revised.rmc
`& htm
`
`Roster
`
`3782r1-M & ht_m
`Consultants
`3782r1_consultants.fl
`& ht_m
`_
`Questlons
`3782q1-Fflf 8‘ m—m
`Intradose 3782q1_02. M
`8‘ ht_m
`
`Briefing Information
`3782b1.htm
`
`Slides 3'782s1.htm
`
`09/11 Pages 1-100
`3782t2 O1. df
`
`3782t2.htm
`
`Pages 101-200
`3782t2 02.pdf
`Pages 201-239
`
`Briefing Information
`3782b2.htm
`
`Questions
`
`3782q2_zevalin.w &
`ht_m
`
`
`3782t2 O3.pdf
`Briefing Information ht_m 375611 03. df
`
`
`Slides 378252.htm
` Pediatric Subcommittee
`06/28 06/28 Pages 1-100
`3756t1 m,
`Agenda
`3756t1 01. df
`3756t1 m
`3756a1 .ht_m, M
`
`Pages 101-200
`375611 02. df
`
`Pages 201-end
`
`Roster
`
`3756r1.ht_m, M
`
`&pfl‘
`
`Slides
`
`3756s1.ht_m
`
`06/07 06/07 Pages 1-100
`f
`3757“
`1.
`http://uNIAN.fda.g ov/ohrms/dockets/ac/cderO1 .htm#Peri pheral %20&%20C entra|%20Nervous
`
`3757t1.m, ht_m
`
`Agenda
`3757a1.mm& M
`
`10/16
`
`PAR1027
`
`CBM of US. Patent No. 7,668,730
`Page 10 of 16
`
`
`
`Page 10 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CD ER 2001 Meeting Documents
`
`Pages 101-201
`375711 02.9df
`
`Questions
`3757q1.nm & M
`
`Briefing Information
`3757b1.ht_m & M
`
`4/24
`
`4/24 3743t1_01.mf
`374311_02.pfl‘
`374311_03.M
`
`3743t1m
`
`Agenda
`3743a1.ht_m & p_df
`
`Roster
`
`3743r1.ht_m, gr
`
`Briefing Information
`3743b1.ht_m & flf
`
`Slides
`
`3743s1.ht_m
`
`Briefing Information 3754b1.ht_m
`
`Peripheral & Central Nervous System Drugs Advisory Committee
`
`Pages 1—100
`3754t1_01.p_df
`
`375411.txt
`
`3754m113fl‘, m Agenda
`3754a1 .pQ‘, m
`
`Pages 101 -200
`3754t1_02.pg‘
`
`Pages 201-300
`3754t1_03.pgf
`
`Pages 301-381
`3754t1_04.pgf
`
`Rosters
`Members
`3754r1_01.m html
`
`Consultants
`3754r1_02.;fl‘, html
`
`Public Hearing
`3754r1_03.;fl,‘, html
`
`Questions
`
`3754q1pfl‘, html
`
`Slides
`
`3/13
`
`3/13 3724t1 .p_chc
`
`3724t1 m
`
`3754s1.ht_m
`
`3724m1.ht_m
`3742m1.pdf
`
`Agenda
`3724a1.g|g, p_df
`
`Roster
`
`3724r1_01.gm, m:
`
`Briefing Info
`3724b1.ht_m
`
`Slides
`
`http://uMANfdag ov/ohrms/dockets/ac/cdero1 .htm#Peri pheral %20&%20C entral%20Nervous
`
`11/16
`
`PAR1027
`
`CBM of US. Patent No. 7,668,730
`Page 11 of 16
`
`
`
`Page 11 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`3724s1.htm
`
`3/14 3724t2.p_df
`
`3724mm
`
`3724m2.mn
`3724m2.p_df
`
`Agenda (DRAFT)
`3724a2.fl, p_df
`
`Roster
`
`3724r1_02.m, pgf
`
`Briefing Info
`3724b2.ht_m
`
`Slides
`
`372452.ht_m
`
`[Top]
`
`
`
`Advisory Committee for Pharmaceutical Science
`
`
`
`
`
`
`
`11/28 11/28 Morning Session
`Pa es 1-100
`Pa e 101-143
`
`
`
`|Word] [ht_m]
`
`Revised Agenda
`W] [ht_m
`version
`ord
`—-] [W—
`versuon]
`
`
`
`Aft
`S
`'
`Paar:°?24_e::'°"
`
`Pages 244282
`
`Draft Agenda 3804a1
`[pdf version|
`
`Rosters
`Committee: 3804r1
`
`[Qdf versionl [ht_m
`version] [Word
`version]
`[pdf xersion|
`Guests:
`[htm version] [Word
`version]
`
`Briefing Information
`3804b1.htm
`
`Slides
`
`1 1/29 Morning Session |Word] |htm]
`Pages 1-100
`Pa‘es 101—141
`
`Aft
`S
`'
`P61621032 :2?”
`_q——
`
`Pages 244-294
`
`Revised Agenda
`|pdf version] |htm
`version |y\_/ord
`‘.
`]
`versnon]
`
`Committee: 3804r1
`.
`[Qdf versnon| [ht_m
`—Ver5i°”] {—Word
`version]
`[pdf versionl
`Guests:
`[htm version] [Word
`version]
`
`Briefing Information
`
`http://uMAN.fda.g ov/ohrms/dockets/ac/cderO1 .htm#Peri pheral %20&%20C entral%20Nervous
`
`12/16
`
`PAR1027
`
`CBM of US. Patent No. 7,668,730
`Page 12 of 16
`
`
`
`Page 12 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CD ER 2001 Meeting Documents
`
`—slides
`
`N_nclinicalStudies Subcommittee
`
`3804b2. htm
`
`
`
`11/13 11/13Pa es1-1OO
`(10, 038)
`
`[M]
`|Word version|
`
`Pages 101- 148
`(6 901)
`
`[p_f] [ht_m] [M] Draft Agenda
`3798a1. [ht_m
`f_ormat] & [M
`f_ormat]
`
`Roster Committee
`Members
`
`[htm format| & [M
`format
`Guests
`
`[htm format| & [pgf
`format
`
`Briefing Information
`3798b1. htm
`
`07/19 07/19 Pages1--1OO
`3763t1 O1.pdf
`
`3763t1.ht_m,m
`
`3763m1.ht_m & M Agenda
`3763a1.ht_m & mf
`
`
`
`Pages 101-200
`376311 02.9df
`
`Pages 201-300
`3763“ 03. df
`
`Pages 301-313
`3763” 04.9df
`
`Roster
`
`3763r1.ht_m & M
`Guest Roster
`
`3763r1_guest.m &
`flf
`FDA Roster
`
`3763r1_fda.d& & pgf
`
`Questions
`
`3763q2.ht_m & pgf
`
`Briefing Information
`3763b1.ht_m
`
`Slides
`
`3763s1.ht_m
`
`7/20 Pages 1-100
`376312 01.pdf
`
`3763t2.ht_m, m
`
`3763m2.ht_m & pgf Agenda
`3763a2.h’t_m & M
`
`Pages 101-171
`3763t2 OZQdf
`
`Guest Roster
`
`3763r2_guest.m &
`flf
`FDA Roster
`
`3763I2_fda.m & M
`
`Slides
`
`376352.ht_m
`
`Orally Inhaled and Nasal Drug Products Subcommittee
`
`7/17
`
`7/17 PageS1-100
`
`3764t1 01 df1
`
`3764t1.ht_m,
`
`t)_(t
`
`3764m1.ht_m &
`
`p_df
`
`Pages 101-200
`764t1 02 d[
`
`http://IANIAN.fda.g ov/ohrms/dockets/ac/cdero1 .htm#Peri pheral %20&%20C entral%20Nervous
`
`Agenda
`3764a1.ht_m & pgf
`
`Roster
`
`3764r1.ht_m & M
`
`13/16
`
`PAR1027
`
`CBM of US. Patent No. 7,668,730
`Page13of16
`
`
`
`Page 13 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CD ER 2001 Meeting Documents
`
`Pages 201-211
`37§4t1 03.9df
`
`Non-Clinical Studies Subcommittee
`
`Open Speakers
`3764mm & mi
`
`Questions
`
`3764q1.ht_m & pg
`
`Briefing Information
`3764b1.ht_m
`
`Slides
`
`3764s1.ht_m
`
`3742t1.pdf
`(10,036)
`
`3742t1m(93)&
`m (100 )
`
`Agenda
`3742a1.ht_m & gr
`
`Roster
`
`3742r1.ht_m & m
`3742r2.ht_m & w
`
`Briefing Info
`3742b1.ht_m & flf
`
`Notice of Meeting
`98frx032301g.ht_m
`98frx032301 g. pgf
`
`Psychopharmacologic Drugs Advisory Committee 2/14
`
`2/14 3685t1.p_f
`
`3685t1.txt
`
`3685m1p_df
`
`Agenda
`
`3685a1.fl, M
`
`Roster
`
`3685r1.@, M
`
`Questions
`
`3685q1.d£, 91f
`
`Briefing Info
`3685b1.ht_m
`
`Slides
`
`2/15 3685t2 .mf
`
`3685t2. txt
`
`3685m2 .p_df
`
`368531.ht_m
`
`Agenda
`3685a2fl, M
`
`Roster
`
`3685mm, pgf
`
`Questions
`
`3685q2.g% M
`
`http://uMAN.fda.g ov/ohrms/dockets/ac/cdero1 .htm#Peri pheral %20&%20C entra|%20Nervous
`
`14/16
`
`PAR1027
`
`CBM of US. Patent No. 7,668,730
`Page 14 of 16
`
`
`
`Page 14 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CD ER 2001 Meeting Documents
`
`Briefing Info
`3685b2.ht_m
`
`Slides
`368532.htm
`
`Pulmonam-Allergy Drugs Advisory Committee
`
`Joint_eetingwith Non rescri tionDrus Adviso Committee
`
`
`05/11
`05/11 Pages1— 100
`3737t1.rtf
`3737m1.M h_tml Agenda
`3737t1 O1.pdf
`3737a1 h_tm, M
`
`
`
`Planning Agenda
`3737a1_planning._htm
`
`M Q
`
`uestions
`
`3737q1. h_tm M
`
`Roster
`Consultants
`
`3737r1 _01. h_tm & M
`
`Members
`
`3737r1 _02. h_tm & M
`
`Open Public Hearing
`3737r1 _03. h_tm & M
`
`Briefing Information
`3737b1. htm
`Petition
`
`Slides 373751. htm
`
`Open Public Hearing
`Presentations
`37370 1. htm
`
`Pages 101 -200
`3737t1 O2. df
`
`Pages 201 -300
`3737t1 03. df
`
`Pages 301 3—45
`3737t1 O4. df
`
`Page updated: March 27, 2007
`
`To |U |MAC Home Pae
`
`Dockets Home Page | Dockets Contacts and Location | Operating Status | Federal Registers
`FDA Home Pag’ e | Search FDA Site | FDA A-Z Index | Contact FDA
`
`FDA/Dockets Management
`
`http://IANIAN.fda.g ov/ohrms/dockets/ac/cdero1 .htm#Peri pheral %20&%20C entral%20Nervous
`
`15/16
`
`PAR1027
`
`CBM of US Patent No. 7,668,730
`Page15of16
`
`
`
`Page 15 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CD ER 2001 Meeting Documents
`
`http://wmfda.gov/ohrms/dockets/ac/cder01 .htm#Peri pheral %20&%20C entral%20Nervous
`
`16/16
`
`PAR1027
`
`CBM of US. Patent No. 7,668,730
`Page 16 of 16
`
`
`
`Page 16 of 16
`
`