7/2/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`
`
`
`FDAHome Pa e | Dockets Home Page | Dockets Contacts and Location |Operating Status | Federal Register
`
`go |AC Home Page
`CDER 2001 Meeting Documents
`
`ort Dru s Adviso Committee
`Anesthetic and Life Su
`
`
`Anti-Infective Drugs Advisory Committee
`Anti-Viral Drugs 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
`
`Oncolo ic Dru sAdviso Committee
`
`Peri heral and Central NervousS stem Dru sAdviso Committee
`
`Adviso Committee for Pharmaceutical Science
`
`Ps cho harmacolo ic Dru sAdviso Committee
`
`Pulmona -AIIer Dru sAdviso Committee
`
`
`Anesthetic and Life Support Drugs Advisory Committee
`
`Transcript PDF
`ID
`(size in kb)
`
`Start Day
`
`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 Draft Agenda
`postponed.
`It will be rescheduled in the future. This
`3778a1_draft.pfl‘
`meeting has been rescheduled for January 30—31,
`.
`2002. You may find additional information at CDER
`Ques"°”s
`3778 1. df
`2002 page.
`q
`p—
`Meeting Info
`mooooomm ht_m
`
`Briefing Information
`3778b1.htm
`
`Docket Number 01N-
`0256
`
`[39.]
`
`Anti-Infective Drugs Advisory Committee
`
`
`
`
`
`11/07 11107 Pages1-1OO
`(8,448)
`
`|Word version]
`|htm version]
`
`|pdfversion][h’i_m FinaIAgenda|Word
`version] |y\_lord
`version] |pdfversion]
`
`http://ViAM/il.fda .g ov/ohrms/doclets/ac/cderOI .htm#Peri pheral%20&%200entral %20N ervous
`
`1/16
`
`PAR1027
`
`IPR of US. Patent No. 7,668,730
`Page 1 of 16
`
` PAR1027
`IPR of U.S. Patent No. 7,668,730
` Page 1 of 16
`
`
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`
`
`
`FDAHome Pa e | Dockets Home Page | Dockets Contacts and Location |Operating Status | Federal Register
`
`go |AC Home Page
`CDER 2001 Meeting Documents
`
`ort Dru s Adviso Committee
`Anesthetic and Life Su
`
`
`Anti-Infective Drugs Advisory Committee
`Anti-Viral Drugs 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
`
`Oncolo ic Dru sAdviso Committee
`
`Peri heral and Central NervousS stem Dru sAdviso Committee
`
`Adviso Committee for Pharmaceutical Science
`
`Ps cho harmacolo ic Dru sAdviso Committee
`
`Pulmona -AIIer Dru sAdviso Committee
`
`
`Anesthetic and Life Support Drugs Advisory Committee
`
`Transcript PDF
`ID
`(size in kb)
`
`Start Day
`
`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 Draft Agenda
`postponed.
`It will be rescheduled in the future. This
`3778a1_draft.pfl‘
`meeting has been rescheduled for January 30—31,
`.
`2002. You may find additional information at CDER
`Ques"°”s
`3778 1. df
`2002 page.
`q
`p—
`Meeting Info
`mooooomm ht_m
`
`Briefing Information
`3778b1.htm
`
`Docket Number 01N-
`0256
`
`[39.]
`
`Anti-Infective Drugs Advisory Committee
`
`
`
`
`
`11/07 11107 Pages1-1OO
`(8,448)
`
`|Word version]
`|htm version]
`
`|pdfversion][h’i_m FinaIAgenda|Word
`version] |y\_lord
`version] |pdfversion]
`
`http://ViAM/il.fda .g ov/ohrms/doclets/ac/cderOI .htm#Peri pheral%20&%200entral %20N ervous
`
`1/16
`
`PAR1027
`
`IPR of US. Patent No. 7,668,730
`Page 1 of 16
`
` PAR1027
`IPR of U.S. Patent No. 7,668,730
` Page 1 of 16
`
`
`
`7/2/2014
`
`Pages 101-200
`(8,549)
`
`Pages 201-307
`(17,286)
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`version]
`
`|htm version|
`
`Draft Agenda |flord
`version| IQdf version|
`|htm version|
`
`Questions |V_Vord
`version| |pdf version|
`|htm version|
`
`Briefing Information
`htm
`
`Slides
`
`10/16
`
`09/12
`
`04/26
`
`10l16 Pages 1-100
`3797t1 01. d
`
`Pages 101-200
`3797t1 02. df
`
`Pages 201-300
`3797t1 03. df
`
`Pages 301-345
`3797t1 04. df
`
`3797t1.[word
`
`Agenda m & M
`
`Version| (477)
`
`& [HTML
`
`Version] (394)
`
`Questions
`
`ht_m & M
`
`Briefing Information
`
`Roster
`Committee Members
`
`htm & M
`
`Slides 3797s1.htm
`
`Summary Minutes
`
`
` 3746a1.flf,ht_m
`
`
`It
`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 for10l16/01.
`
`04/26 Pages 1- 100
`3746t1_01.;mc
`(10,540)
`
`3746t1m(388) M ht_m @
`& m (392)
`
`Pages 101-200
`3746t1_02.mf
`(10,646)
`
`Pages 201-339
`3746t1_03.m
`(19,170)
`
`Briefing Info.
`3746b1.ht_m
`
`Roster
`
`3746r1_01committee.tflf,
`ht_m
`3746r1_029uest.Ldf, ht_m
`
`Slides
`
`3746s1.ht_m
`
`Questions
`
`M ht_m M
`
`04/23 04/23 3744t1_01.m& 3744t1.m
`ht_m
`
`http://wwada .g ov/ohrm/doclets/ac/cderOl .htm#Peri pheral%20&%200entral %20N ervous
`
`Notice of Mtg.
`032301 d.ht_m & p_df
`
`Briefing Information
`3744b1.ht_m
`
`Agenda
`3744a1mf, ht_m
`
`Roster
`
`2/16
`
`PAR1027
`
`IPR of US. Patent No. 7,668,730
`Page 2 of 16
`
` PAR1027
`IPR of U.S. Patent No. 7,668,730
` Page 2 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`3744r1.mf, ht_m
`
`Questions
`
`3744mm, ht_m
`
`Slides
`
`3744s1.flf
`
`04/24 '3a744t2.p_<:hc & ht_m 3744mm
`
`Briefing Information
`3744b2.ht_m
`
`Agenda
`3744a2.p_df, ht_m
`
`Roster
`
`3744r2.mf, ht_m
`
`Questions
`
`3744q2.pdf, ht_m
`
`Slides
`
`374452.ht_m
`
`
`
`01/30 01/30 3719t1 O1.pdf
`(6126)
`3719t1 02. df
`(6374)
`3719t1 03. df
`
`3719t1.m (439) 3719m1.m,p_df Briefing Package
`3719b1.htm
`R t
`05 er
`m
`
`(6385)
`3719t1 04. df
`
`(6428)
`
`Slides
`371951.htm
`
`Agenda
`3719a1.htm
`
`Question
`3719-1.htm
`
`To{—9.1
`
`Anti-Viral Drugs Advisory Committee
`
`12/12
`
`12/12 Pages 1-100
`Pages 101-200
`
`d c ht
`
`Pages 201-211
`
`http://wwada .g ov/ohrms/doclets/ac/cderOl .htm#Peri pheral%20&%200entral %20N ervous
`
`Notice of Meeting
`|text
`d
`] [Lt]
`Draft Agenda [MI
`
`[ht_m] [Word]
`
`Final Agenda [pQ‘]
`{ht_m} [_W0rd]
`
`Questions [M] [ht_m]
`[Word|
`
`Roster
`
`Committee [M]
`
`3/16
`
`PAR1027
`
`IPR of US. Patent No. 7,668,730
`Page 3 of 16
`
` PAR1027
`IPR of U.S. Patent No. 7,668,730
` Page 3 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`10/03
`
`10/03 Pages 1 — 100 M ht_m
`
`(9,207)
`
`
`[htm| [Word]
`Consultants &
`
`Guests [m [ht_m]
`[Word]
`
`Briefing Information
`
`Slides
`
`Dralt Agenda [Ml
`{ht_m}
`
`Pages 101-200 p_df
`(9,581)
`
`Pages 201-300 M
`(10,067)
`
`Pages 301-326 04.9df
`(8,207)
`
`
`
`10/04 Pages 1 - 100 M ht_m
`(9,357)
`
`Pages 101-200 p_oh‘
`(9375)
`
`Pages 201-300 p_df
`(9990)
`
`Pages 301-327 p_df
`(8,452)
`
`m (271)
`
`02/27 02/27 3731t1 01.gdf
`(6394)
`3731t1 02.pdf
`(6275)
`3731t1 03.pdf
`(3920)
`
`Final Agenda [M]
`[ht_m]
`
`Roster
`
`Committee [M] [ht_m]
`Consultants &
`
`Guests [M] [ht_m]
`
`Questions Q
`
`Briefing Information
`
`Agenda M &
`ht_m
`
`Roster
`Committee w & ht_m
`Consultants &
`
`Guests M
`
`Questions M
`
`Briefing Information
`ht_m
`
`Slides
`
`Slides ht_m
`
`Agenda
`m, M
`8rd| es
`htm
`—
`Roster
`Part 1 M, M
`Part Zdfl, M
`
`Briefing Information
`ht_m
`
`Questions
`
`01/10 01/10 3676t1 apdf
`3676t1 b.pdf
`3676t1 c.pdf
`3676t1 dpdf
`
`m
`
`http:/AMMNfda .g ov/ohrms/doclets/ac/cderOl .htm#Peri pheral%20&%200entral %20N ervous
`
`m, M
`
`Agenda
`M. m
`
`Rafter
`
`4/16
`
`PAR1027
`
`IPR of US. Patent No. 7,668,730
`Page 4 of 16
`
` PAR1027
`IPR of U.S. Patent No. 7,668,730
` Page 4 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`doc, M
`
`Briefing Information
`ht_m
`
`Slides
`
`ht_m
`
`Agenda
`m, P_df
`
`Briefing Information
`ht_m
`
`Slides
`
`ht_m
`
`Agenda
`3779a1.htm & M
`
`Rosters
`Committee
`
`3779r1_committee.ht_m & M
`
`Consultants
`
`3779r1_consultants.m_m & p_df
`
`Public Hearing
`3779r1_public_hearing.ht_m &
`
`M B
`
`riefing Information
`3779b1.ht_m
`
`Questions
`
`3779q1.ht_m & M
`
`Revised Questions
`
`3779q1_revised.ht_m & p_df
`
`Slides
`377951.htm
`
`01/11 3678t1_a.rmc
`3678t1_b.pflc
`3678t1_c.mf
`3678t1_d.pQ‘
`
`
`
`Arth ritis_Advisory Committee
`
`112/07-———C Iosed Meeting 08/16 08/16 3779t1 .pdf (320)
`
`08/17 Pages 1-100
`3779t2 01.pdf
`
`Pages 101-159
`377912 02.9df
`
`3779m2 .p_df Agenda
`& ht_m
`3779a2.ht_m & M
`
`Rosters
`Committee
`3779r2_committee.ht_m & M
`
`http://IMM/vfda .g ov/ohrms/doclets/ac/cderOl .htm#Peri pheral%20&%200entral %20N ervous
`
`5/16
`
`PAR1027
`
`IPR of US. Patent No. 7,668,730
`Page 5 of 16
`
` PAR1027
`IPR of U.S. Patent No. 7,668,730
` Page 5 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`Consultants
`
`3779r2_consultants.m_m & p_df
`
`Public Hearing
`3779r1_public_hearing.ht_m &
`
`M B
`
`riefing Information
`3779b2.ht_m
`
`Agenda
`
`3740a1.ht_m & M
`_
`_
`Briefing Information
`3740b1.ht_m
`
`Questions
`
`3740q1.ht_m & M
`
`Roster
`
`3740r1_01 ht_m & M
`3740r1_02 ht_m & M
`
`Slides
`374051.htm
`
`Agenda
`3677a1.m,p_ohc
`R t
`°5 er
`3677r1-01'M’ 91f
`Guest Roster
`3677r1_02.m, M
`
`Briefing Information
`3677b1.ht_m
`
`04/19 04/19 374Ot1_01.[mc
`
`3740t1 .if
`
`3740t1_02.pfl‘
`3740t1_03.pfl‘
`
`3677t1 .rtf (561)
`
`02/07 02/07 3677t1_01.pfl‘
`(6421)
`3677t1_02.[mc
`(6733)
`3677t1_03.pfl‘
`(2448)
`
`
`
`Questions
`
`3677q1.M, M
`
`Slides
`
`3677s1.ht_m
`
`Briefing Package
`3677b2.htm
`A
`d
`gen a
`mmm
`
`Questions
`m & pgf
`367792 02.dOC & p_df
`
`Slides
`
`367752.ht_m
`
`
`
`[39.]
`
`3677t2.rtf (597)
`
`02/08 3677t2 O1. df
`(6774)
`3677t2 02. df
`(6852)
`3677t2 03. df
`
`(2918)
`
`http:/AAAM/vfda .g ov/ohrms/doclets/ac/cderOl .htm#Peri pheral%20&%200entral %20N ervous
`
`Cardiovascular and Renal Drugs Advisory Committee
`
`6/16
`
`PAR1027
`
`IPR of US. Patent No. 7,668,730
`Page 6 of 16
`
` PAR1027
`IPR of U.S. Patent No. 7,668,730
` Page 6 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`10/11
`
`
`10/11 Morning Session
`Pa es1—1OO df
`
`|Wordlm1
`
`Agenda
`
`3793a1.ht_m & M
`
`Pa es 101-129 df
`Afternoon Session
`Pa es 130-229 d
`
`08/09 08/09 Pages 1-100
`3775t1 01. df
`
`Pa es 230-274 d
`
`
`
`Pages 101-200
`377511 02. df
`
`Pages 201-300
`377511 03. df
`
`Pages 301-400
`377511 04. df
`
`Pages 401-411
`377511 05. df
`
`08/10 Pages 1-100
`377512 01. df
`
`Pages 101-200
`377512 02. df
`
`Pages 201-228
`377512 03. df
`
`5/24
`
`5/24 3749t1_01.;mc
`
`(9171)
`374911_02.mf
`(8690)
`374911_03.w
`(7469)
`374911_04.mf
`(4025)
`
`377511 .rtf (444)
`
`377512.rtf (299)
`
`374911 m (437)
`
`Briefing Information
`
`Questions
`
`3793q1.ht_m & M
`
`Slides 3793s1.htm
`
`Agenda
`3775a1.ht_m, pfl‘
`
`Roster
`3775r1 .htm
`
`Briefing Information
`3775b1.htm
`
`Ques1ions
`Remondulin
`
`3775q1_01.m,
`
`h1
`
`Extraneal
`
`3775q1_02.}:&f,
`
`h1_m
`
`Slides
`377551.htm
`
`Briefing Information
`3775b2.htm
`
`Questions
`bosenton
`
`37754219113
`
`ht_m
`
`Briefing Information
`
`3749b1.ht_m
`
`Agenda
`374981'pi8‘ h1_m
`Questions
`3749q1 m & ht_m
`
`5/25 374912_01.p_df
`(9171)
`
`3749mm (465)
`
`3749t2_02.;m
`(8465)
`3749t2_03-M
`(8352)
`3749t2_04.mf
`http:/AAAM/vfda .g ov/ohrm/dociets/ac/cder01.htm#Peripheral%20&%200entral%20N ervous
`
`Briefing Information
`3749b2.ht_m
`
`.
`335%“
`q 'p— —m
`
`7/16
`
`PAR1027
`
`IPR of US. Patent No. 7,668,730
`Page 7 of 16
`
` PAR1027
`IPR of U.S. Patent No. 7,668,730
` Page 7 of 16
`
`
`
`7/2/2014
`
`|
`
`ToE
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`l
`
`|(7345)
`
`l
`
`l
`
`l
`
`I
`
`Endocrinologic and Metabolic Drugs Advisory Committee
`
`07/26 07/26 Pages 1-100
`3761 t1 O1. df
`
`3761t1.htm
`
`3761m1.p_df &
`ht_m
`
`Notice of Meeting
`June 8, 2001 M
`
`(9,446)
`
`Pages 101-200
`376111 02.pdf (9,613)
`
`Pages 201-300
`376111 03.9df (9,586)
`
`Pages 301-342
`376111 O4.|gdf (8,306)
`
`07/27 Pages 1—100
`376112 01 .de
`(8,398)
`
`3761 t2. htm
`
`3761 mam &
`h_tm
`
`Pages 101-200
`376112 02.pdf (8,508)
`
`Pages 201-300
`376112 03.9df (8,318)
`
`Pages 301-359
`376112 04.9df (9,991)
`
`
`
`ht
`
`m A
`
`genda
`3761a11flf,
`
`Questions
`
`3761q1.w,
`
`ht
`
`Briefing Information
`3761 b1 .ht_m
`
`Slides
`3761s1.h1m
`
`Agenda
`3761a2.flf,
`
`ht_m
`
`Questions
`
`3761q2.flf,
`
`ht
`
`Roster
`
`3761 r2. M» ht_m
`
`Briefing Information
`3761b2.ht_m
`
`Slides
`376112.htm
`
`Nonprescription Drugs Advisory Committee
`
`
`
`
`
`Joint meeting with Pulmona-A||er Dru s Adviso Committee
`
`05/11
`
`05/11 Pages 1-100
`373711 01.pdf
`
`373711 .if
`
`3737m1.P_f, html Agenda
`3737a1.ht_m,pQc
`
`Pages 101-200
`373711 02.9df
`
`Pages 201-300
`373711 03.9df
`
`http://VIAMN.fda .g ov/ohrms/doclets/ac/cderOl .htm#Peri pheral%20&%200entral %20N ervous
`
`Planning Agenda
`3737a1_planning.ht_m,
`M
`
`Questions
`
`8/16
`
`PAR1027
`
`IPR of US. Patent No. 7,668,730
`Page 8 of 16
`
` PAR1027
`IPR of U.S. Patent No. 7,668,730
` Page 8 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`Pages 301 -345
`3737t1 04.9df
`
`3737q1.ht_m, M
`
`Roster
`Consultants
`
`3737r1_01.ht_m & p_df
`
`Members
`
`3737r1_02.ht_m & flf
`
`Open Public Hearing
`3737r1_03.ht_m & pgf
`
`Briefing Information
`3737b1.htm
`Petition
`
`Slides 3737s1.htm
`
`Open Public Hearing
`Presentations
`37370 o1.htm
`
`Oncologic Drugs Advisory Committee
`
`
`
`12/05 12/05 Pages 1—100
`
`fl
`
`Pa es ““200
`Pa es 201—300
`
`Pa es 301-362
`
`12/06 Pages 1-100
`
`m
`
`Pa 95101200
`
`Pa es 201-300
`pa SS 301_397
`
`Draft Agenda
`3815a1 |pdf version]
`|htm version] |Word
`m]
`
`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
`
`Pediatric Subcommittee
`
`11/28 1 1/28 Moming Session
`Pages 1-100 pdf
`
`|Word.]lm1
`
`Pages 101—202
`
`http:/AMMNfda .g ov/ohrms/doclets/ac/cderOI .htm#Peri pheral%20&%200entral %20N ervous
`
`Draft Agenda
`3803a1.|Word
`version] |htm version]
`|pdf version]
`
`9/16
`
`PAR1027
`
`IPR of US Patent No. 7,668,730
`Page 9 of 16
`
` PAR1027
`IPR of U.S. Patent No. 7,668,730
` Page 9 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`p_df
`Afternoon Session
`Pages 203—302
`911‘
`
`Pages 303-405 pdf
`
`Roster 3803r1.[Word
`—Ver5l°“] l—htmvergionl [91“
`m}
`Questions 3803q1. [Word
`version] [htm version] [M
`version]
`
`Briefing Information
`3803b1.htm
`
`Slides 3803s1.htm
`
`09/10 09/10 Moming Session Morning Session
`Pages 1-100
`3782t1 01.htm
`3782t1 01a.pdf
`(139)
`(10,008) Pages
`1014 79
`3782t1 01b. df
`
`_
`Aflemoon Sessmn
`3782t1 02.ht
`m
`
`Afternoon Session
`pages 1-100
`3782t1 023-90”
`(9,796) Pages 101-
`200 3782t1 02b.gdf
`(9,878)
`Pages 201—225
`3782t1 02c. ;df
`(2,226)
`
`Agenda
`3782a1.M& ht_m
`Revised Agenda
`3782a1_revised.p_df
`& htm
`—
`
`Roster
`
`3782r1-M & ht_m
`Consultants
`3782r1_consultants.pfl
`& ht_m
`_
`QUeStlonS
`”mil-M & ht—m
`Intradose 3782q1_02. Ldf
`8‘ ht—m
`
`Briefing Information
`3782b1.htm
`
`Slides 378281.htm
`
`09/11 Pages 1-100
`3782t2 01. df
`
`3782t2.htm
`
`Pages 101-200
`3782t2 02.pdf
`Pages 201-239
`
`Briefing Information
`3782b2.htm
`
`3782q2_zevalin.Ldf &
`ht_m
`
`
`
`3782t2 03.pdf Questions
`
`
`Slides 378282.htm
` Pediatric Subcommittee
`06/28 06/28 Pages 1-100
`3756t1.1f,
`Agenda
`3756t1 01.pdf
`3756t1 .m
`3756a1.ht_m,mf
`
`Pages 101-200
`3756t1 02.9df
`
`Pages 201-end
`3756t1 O3.pdf
`
`Roster
`3756r1.ht_m, [flf
`
`Briefing Information ht_m
`& Ldf
`
`Slides
`
`375651. ht_m
`
`06/07 06/07 Pages 1-100
`3757t1 01.pdf
`http:/AAAM/vfda .g ov/ohrms/doclets/ac/cderOI .htm#Peri pheral%20&%200entral %20N ervous
`
`3757t1 .m, ht_
`
`Agenda
`3757a1.ht_m& p_df
`
`10/16
`
`PAR1027
`
`IPR of US. Patent No. 7,668,730
`Page 10 of 16
`
` PAR1027
`IPR of U.S. Patent No. 7,668,730
` Page 10 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`Pages 101-201
`3757t1 02.pdf
`
`Questions
`3757q1.ht_m & M
`
`Briefing Information
`3757b1.ht_m & M
`
`4/24
`
`4/24 3743t1 0_1.;mc
`3743t1_02.m
`3743t1_03.;m
`
`Pediatric Subcommittee
`
`3743t1 if
`
`Agenda
`3743a1.ht_m & m
`
`Roster
`
`3743r1.ht_m, @
`
`Briefing Information
`3743b1.ht_m & M
`
`Slides
`
`374351.ht_m
`
`
`
`Peripheral & Central Nervous System Drugs Advisory Committee
`
`Pages 1—100
`
`3—754t1.txt
`
`3754m1.mf,h_mtl Agenda
`
`3754t1_01 1w
`
`Pages 101-200
`3754t1_02.;flf
`
`Pages 201-300
`3754t1_03.;flf
`
`Pages 301-381
`3754t1_04.w
`
`3754a1.mlf, m
`
`Rosters
`Members
`3754r1_01.flm
`
`Consultants
`3754r1_02.flf, m
`
`Public Hearing
`3754r1_03.mf, htm
`
`I
`
`Questions
`
`3754q1.m, htm
`
`I
`
`Briefing Information
`3754b1.ht_m
`
`Slides
`
`3/13
`
`3/13 3724t1 .mf
`
`3724t1 .r_tf
`
`3754s1.ht_m
`
`3724m1.ht_m
`3742m1.plf
`
`Agenda
`3724a1M, M
`
`http:/AAAM/vfda .g ov/ohrms/doclets/ac/cderOl .htm#Peri pheral%20&%200entral %20N ervous
`
`Roster
`
`3724r1_o1.cm, w
`
`Briefing Info
`3724b1.ht_m
`
`Slides
`
`11/16
`
`PAR1027
`
`IPR of US. Patent No. 7,668,730
`Page 11 of 16
`
` PAR1027
`IPR of U.S. Patent No. 7,668,730
` Page 11 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`3724s1.ht_m
`
`3724mm
`
`3724m2.ht_m
`3724m24fif
`
`Agenda (DRAFD
`3724a2.m, M
`
` 3/14 3724t2.pdf
`
`Roster
`
`3724r1_02.dfl, p_df
`
`Briefing Info
`3724b2.ht_m
`
`Slides
`
`372452.ht_m
`
`
`Advisory Committee for Pharmaceutical—Science
`
`11/28 11/28 Morning Session |Wordh]|tm]
`Pa es 1— 100
`Pa es 101-143
`
`Aft
`S
`'
`P362310343::'O”
`
`Pa es 244-282
`
`
`
`Revised Agenda
`lpdf version] |htm
`version |Word
`-—]
`verSIon]
`
`Draft Agenda 3804a1
`[pdf version|
`
`Rosters
`Committee: 3804r1
`
`[pdf version| [ht_m
`ve_rsion] [Word
`ve_rsion]
`[gdfversionl
`Guests:
`[htm version] [Word
`ve_rsion]
`
`Briefing Information
`
`m S
`
`lides
`
`11/29 Moming Session |Wor] [_]
`Pages 1-100
`Pages 101 141
`'
`
`3:6;10‘1’2232?”
`
`Pages 244-294
`
`http://IMMN.fda .g ov/ohrms/doclets/ac/cderOl .htm#Peri pheral%20&%200entral %20N ervous
`
`Revised Agenda
`|pdf version] [ht_m
`m] [M
`version]
`
`Committee: 3804r1
`[Qdf version| [ht_m
`version] [M
`version]
`[gdfversionl
`Guests:
`
`[htm version] [Word
`version]
`
`Briefing Information
`
`12/16
`
`PAR1027
`
`IPR of U.S. Patent No. 7,668,730
`Page 12 of 16
`
` PAR1027
`IPR of U.S. Patent No. 7,668,730
` Page 12 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`3804b2.htm
`
`—Slides
`
`N_nclinicalStudies Subcommittee
`
`11/13 11/13Pa es1-1OO
`(10,038)
`
`[W]
`[Word version|
`
`[ID—f]
`
`Pages 101- 148
`(6 901)
`
`[ht_m] [M] DraftAgenda
`3798a1. [ht_m
`f_ormat] & [p_df
`f_ormat]
`
`Roster Committee
`Members
`
`[h1m format| & [Ldf
`format
`Guests
`
`[h1m format| & [M
`fo rm at
`
`Briefing Information
`3798b1. htm
`
`07/19 07/19 Pages 1—100
`3763t1 01.pdf
`
`3763m1.ht_m & pg‘ Agenda
`3763a1.ht_m & M
`
`
`
`Roster
`
`3763r1.ht_m & m
`Guest Roster
`
`3763r1_guest.m &
`
`MF
`
`DA Roster
`
`3763r1_fda.dfl & M
`
`Questions
`
`3763q2.ht_m & pgf
`
`Briefing Information
`3763b1.ht_m
`
`Slides
`
`376351.ht_m
`
`Pages 101-200
`376311 02.9df
`
`Pages 201-300
`376311 03.pdf
`
`Pages 301-313
`376311 04.|gdf
`
`7/20 Pages 1—100
`3763t2 01.pdf
`
`376312.ht_m, m
`
`3763m2.ht_m & M Agenda
`3763a2.ht_m & M
`
`Pages 101-171
`376312 02.9df
`
`Guest Roster
`
`3763r2_guest.m &
`pgf
`FDA Roster
`
`3763r2_fda.dfl & mf
`
`Slides
`
`376352.ht_m
`
`Orally Inhaled and Nasal Drug Products Subcommittee
`
`7/17
`
`7/17 Pages1—100
`376411 01.9df
`
`376411.ht_m,
`
`t)_(t
`
`3764m1.ht_m &
`
`M
`
`Pages 101-200
`376411 02.gdf
`
`http://VIIIM/I/fda .g ov/ohrms/doclets/ac/cderOl .htm#Peri pheral%20&%200entral %20N ervous
`
`Agenda
`3764a1.ht_m & M
`
`Roster
`
`3764r1.ht_m & M
`
`13/16
`
`PAR1027
`
`IPR of U.S. Patent No. 7,668,730
`Page130f16
`
` PAR1027
`IPR of U.S. Patent No. 7,668,730
` Page 13 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`Pages 201-211
`3764t1 03. pdf
`
`Non Clinical Studies Subcommittee
`
`Open Speakers
`3764r1.ht_m & mf
`
`Questions
`
`3764q1.ht_m & p_df
`
`Briefing Information
`3764b1.ht_m
`
`Slides
`
`3764s1.ht_m
`
`3742t1.pdf
`(10,036)
`
`3742t1.fl(93)&
`m (100 )
`
`Agenda
`374231.ht_m & M
`
`Roster
`
`3742r1.ht_m & M
`3742r2.ht_m & M
`
`Briefing Info
`3742b1.ht_m & pdf
`
`Notice of Meeting
`98frx032301g.ht_m
`98frx032301g.p_df
`
`
`
`Psychopharmacologic Drugs Advisory Committee
`
`2/14
`
`2/14 3685t1.p_df
`
`3685t1.txt
`
`3685m1.p_df
`
`Agenda
`
`3685a1.m,p_ch‘
`
`Roster
`
`3685r1 -M, M
`
`Questions
`
`3685q1fl, M
`
`Briefing Info
`3685b1.ht_m
`
`Slides
`
`2/15 3685t24fl‘
`
`3685t2 .m
`
`3685m2m‘
`
`http://Viiiii/iALfda .g ov/ohrms/doclets/ac/cderOl .htm#Peri pheral%20&%200entral %20N ervous
`
`368551 .ht_m
`
`Agenda
`3685a2.M, p_df
`
`Roster
`
`3685mm, fl
`
`Questions
`
`3685q2-M, M
`
`14/16
`
`PAR1027
`
`IPR of U.S. Patent No. 7,668,730
`Page 14 of 16
`
` PAR1027
`IPR of U.S. Patent No. 7,668,730
` Page 14 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`Briefing Info
`3685b2.ht_m
`
`Slides
`
`368552.ht_m
`
`PulmonaLy-Allergy Drugs Advisory Committee
`
`Joint meeting with Nonprescription Drugs Advisop/ Committee
`
`05/11
`
`05/11 Pages 1-100
`3737t1 O1.pdf
`
`3737t1 .if
`
`3737m1.p_df, html Agenda
`3737a1.ht_m,p_df
`
`
`
`Pages 101-200
`3737t1 02. df
`
`Pages 201-300
`3737t1 03. df
`
`Pages 301-345
`3737t1 04. df
`
`Planning Agenda
`3737a1_planning.ht_m,
`m
`
`Questions
`
`3737611 .ht_m, mt
`
`Roster
`Consultants
`
`3737r1_01.ht_m & M
`
`Members
`
`3737r1_02.ht_m & M
`
`Open Public Hearing
`3737r1_03.ht_m & Ldf
`
`Briefing Information
`3737b1.htm
`Petition
`
`Slides 3737s1.htm
`
`Open Public Hearing
`Presentations
`37370 1.htm
`
`Page updated: March 27, 2007
`
`Ep | 9p | 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://wwada .g ov/ohrms/doclets/ac/cderOl .htm#Peri pheral%20&%200entral %20N ervous
`
`15/16
`
`PAR1027
`
`IPR of US. Patent No. 7,668,730
`Page 15 of 16
`
` PAR1027
`IPR of U.S. Patent No. 7,668,730
` Page 15 of 16
`
`
`
`7/2/2014
`
`Advisory Committees: CDER 2001 Meeting Documents
`
`http://wwada .g ov/ohrm/doclets/ac/cder01.htm#Peripheral%20&%200entral%20N ervous
`
`16/16
`
`PAR1027
`
`IPR of U.S. Patent No. 7,668,730
`Page 16 of 16
`
` PAR1027
`IPR of U.S. Patent No. 7,668,730
` Page 16 of 16
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
