7/2/2014
`
`CDER 2001 AdvisoryComnitlee Meeting Documents
`
`W ”-" “k ‘
`
`J" ' E "1" ‘
`
`http //Www.fdagov/ohrms/dockets/ac/cderm.htm
`
`JUN OCT
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`iii/til” lilllllllil I I h I I III I III III I 2000 2001MM 01 -12 Jul 12 200:
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`
`[Federal Registers ] [FDA Home Page ]|!)_orkets Hume PageIICBER CDRH]|OC [LENAC \Vhat‘s New]
`IAeeessibilitv IELmail ] Dockets Management Branch, 5630 Fishers lane 7 Room 10617 HFA7305, Roekville. MD,
`20852; 301-827—6860; Fax 301—827—6870
`
`9/13
`
`9/14 Due to the events of this week, this meeting has been postponed It will be Draft Agenda
`rescheduled in the future. Please check here for the new date.
`3778a1_draft.[£f
`
`Que stions
`3778q1.1Ldf
`
`Meeting Info
`m000001.pdf, ht_m
`
`Brie fing Information
`3778b1.htm
`
`Docket Number 01N-0256
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`09/12
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`09/12 Due to the events of this week, this meeting has been postponed. [twill be rescheduled in the future.
`Please check here for the new date.
`
`3746t1.m‘ (388) & m
`(392)
`
`4/26
`
`4/26
`
`Pages 1- 100
`3746t1_01.1fl
`(10,540)
`
`Pages 101-200
`3746t1_02.p£f
`(10,646)
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`Pages 201-339
`3746t1_03.1fl
`(19,170)
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`._
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`3746r1_01eommittee.[£f,
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`3746rl_02guest.1fl, ht_m
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`Slides
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`3746s 1.ht_m
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`4/23
`
`4/23
`
`3744t1_01.1fl & ht_m
`
`3744t1.if
`
`Notice of Mtg.
`032301 dht_m & pfl'
`
`Briefing Information
`3744b1.h1;m
`
`https://web.archive.org/web/20011004081740/http://\rMAN.fda.gov/ohrms/doclets/ac/cderm .htm
`
`1/11
`
`PAR1020
`
`IPR of US. Patent No. 7,668,730
`Page 1 of11
`
` PAR1020
`IPR of U.S. Patent No. 7,668,730
` Page 1 of 11
`
`
`
`CDER 2001 AdvisoryComnitlee Meeting Documents
`
`W ”-" “k ‘
`
`J" ' E "1" ‘
`
`http //Www.fdagov/ohrms/dockets/ac/cderm.htm
`
`JUN OCT
`
`“0‘
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`‘ 4 ’
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`99 captures
`”allmmii'ifl
`iii/til” lilllllllil I I h I I III I III III I 2000 2001MM 01 -12 Jul 12 200:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[Federal Registers ] [FDA Home Page ]|!)_orkets Hume PageIICBER CDRH]|OC [LENAC \Vhat‘s New]
`IAeeessibilitv IELmail ] Dockets Management Branch, 5630 Fishers lane 7 Room 10617 HFA7305, Roekville. MD,
`20852; 301-827—6860; Fax 301—827—6870
`
`9/13
`
`9/14 Due to the events of this week, this meeting has been postponed It will be Draft Agenda
`rescheduled in the future. Please check here for the new date.
`3778a1_draft.[£f
`
`Que stions
`3778q1.1Ldf
`
`Meeting Info
`m000001.pdf, ht_m
`
`Brie fing Information
`3778b1.htm
`
`Docket Number 01N-0256
`
`
`
`v.
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`4,_%/
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`09/12
`
`09/12 Due to the events of this week, this meeting has been postponed. [twill be rescheduled in the future.
`Please check here for the new date.
`
`3746t1.m‘ (388) & m
`(392)
`
`4/26
`
`4/26
`
`Pages 1- 100
`3746t1_01.1fl
`(10,540)
`
`Pages 101-200
`3746t1_02.p£f
`(10,646)
`
`Pages 201-339
`3746t1_03.1fl
`(19,170)
`
`. _
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`'
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`._
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`3746r1_01eommittee.[£f,
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`3746rl_02guest.1fl, ht_m
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`Slides
`
`3746s 1.ht_m
`
`4/23
`
`4/23
`
`3744t1_01.1fl & ht_m
`
`3744t1.if
`
`Notice of Mtg.
`032301 dht_m & pfl'
`
`Briefing Information
`3744b1.h1;m
`
`https://web.archive.org/web/20011004081740/http://\rMAN.fda.gov/ohrms/doclets/ac/cderm .htm
`
`1/11
`
`PAR1020
`
`IPR of US. Patent No. 7,668,730
`Page 1 of11
`
` PAR1020
`IPR of U.S. Patent No. 7,668,730
` Page 1 of 11
`
`
`
`7/2/2014
`
`C DER 2001 Advisory Committee Meeting Documents
`
`Agenda
`3744a1.1:fl, ht_m
`
`Roster
`
`3744r1.1fl‘, ht_m
`
`Questions
`
`3744q1.1Ldf, ht_m
`
`Slides
`
`3744s 1 .[fl'
`
`Briefing Information
`3744b2.ht_m
`
`4/24 3744t2.fl & ht_m
`
`3744t2.lf
`
`3744q2-mf, ht_m Slides
`
`01/30
`
`01/30 3719t1_01.pdf 16126)
`3719t1 02. df (6374)
`
`3719t1_03. df (6385)
`3719t1_04.pdf (6428)
`
`3719t1.lf (439)
`
`3719m1.m, fl
`
`Agenda
`3744a2.1Ldf, ht_m
`
`Roster
`
`3744r2.mf, ht_m
`
`Questions
`
`374452.1fl'
`
`Briefing Package
`3719b1.htm
`
`Roster
`3719r1.htm
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`Slides
`3719sl.htm
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`Agenda
`3719a1.htm
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`Question
`3719 1.htm
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`| Top
`
`Anti-Viral Drugs Advisory Committee
`
`10/03
`
`10/03
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`https://web.archive.org/webl20011004081740/http://V\MAN.fda.gov/ohrms/dockets/ac/cderm.htm
`
`Draft Agenda 3792a1.pi
`& ht_m
`
`Final Agenda
`3792a1.pdf & ht_m
`
`Roster
`Committee
`
`3792r1_01.1fl & ht_m
`Consultants & Guests
`
`2/1 1
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`PAR1020
`
`IPR of US. Patent No. 7,668,730
`Page 2 of 11
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` PAR1020
`IPR of U.S. Patent No. 7,668,730
` Page 2 of 11
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`
`
`7/2/2014
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`C DER 2001 Advisory Committee Meeting Documents
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`10/04
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`3792rl_02.pdf
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`Questions 3792g1.pdf
`
`Briefing Information
`3792b1.htm
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`Agenda 3792a2.mif &
`ht_m
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`2/27
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`3731t1_01. df(6394)
`3731t1_02. df(6275)
`3731t1 03.
`(if (3920)
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`3731t1.rtf(271)
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`1/10
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`3676t1_a. df
`.
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`3676t1.11;f
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`.
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`
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`Roster
`Committee
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`3792r2_01.pdf & ht_m
`Consultants & Guests
`
`3792r2_02.1fl
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`Questions 3792 2. df
`
`Briefing Information
`3792b2.htm
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`Agenda
`3731a1.M,pfl
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`Slides
`
`373151.hfl
`
`Roster
`
`3731r1.m,pif
`3731r2.m, 1w
`
`Briefing Information
`3731bl.ht_m
`
`Que stions
`
`3731q1.d9_c, psi:
`
`Agenda
`3676a1.Ma @
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`Roster
`3676rl.fl, pdf
`
`Briefing Information
`3676b] .htm
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`Slides
`36765 1.htm
`
`Agenda
`3678a] .M, pdf
`
`Briefing Information
`3678bl.ht_m
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`Slides
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`3578t1.n;f
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`1/11
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`3678t1_a.pd_f
`3678t1_b.1Ldf
`3678t1_c.1Ldf
`3678t1 (11);“
`_
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`| Top
`
`https://web.archive.org/webl20011004081740/http://\/\MAN.fda.gov/ohrms/dockets/ac/cderm.htm
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`3678s 1.hfl
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`3/1 1
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`PAR1020
`
`IPR of US. Patent No. 7,668,730
`Page 3 of 11
`
` PAR1020
`IPR of U.S. Patent No. 7,668,730
` Page 3 of 11
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`
`
`7/2/2014
`
`C DER 2001 Advisory Committee Meeting Documents
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`Arthritis Advisory Committee
`
`8/16
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`8/16
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`3779tl.pdf (320)
`
`Agenda
`3779a1.ht_m & pdf
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`Rosters
`Committee
`
`37791'1_committee.htl_n & mfl
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`Consultants
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`37791-l_consultants.ht_m & pdf
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`Public Hearing
`37791'1_public_hearing.ht_m & fl
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`
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`8/17
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`Pages 1-100
`3779t2_01. df
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`Pages 101-159
`3779t2_02. df
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`Briefing Information
`3779b1.ht_m
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`Questions
`3779q1.ht_m & Ifi
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`Revised Questions
`
`3779q1_revised.ht_m & fl
`
`Slides
`3779sl.htm
`
`3779m2.1Ldf & hfl Agenda
`3779a2.ht_m & [fl
`
`Rosters
`Committee
`37791'2_committee.th & pdf
`
`Consultants
`
`37791'2_consultants.ht_m & pdf
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`Public Hearing
`3779r1_public_hearing.ht_m & mi
`
`Briefing Information
`3779b2.ht_m
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`4/19
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`4/20
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`3740t1_01.,fi
`3740t1_02.,fi
`3740t1_03.pd_f
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`3740mm
`
`https://web.archive.org/webl20011004081740/http://\/\MAN.fda.gov/ohrms/dockets/ac/cderm.htm
`
`Agenda
`3740a1.ht_m & pi
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`Briefing Information
`3740bl .ht_m
`
`Questions
`
`3740q1.ht_m & [fl
`
`Roster
`
`3740r1_01 ht_m & pdf
`37401-l_02 ht_m & [fl
`
`4/1 1
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`PAR1020
`
`IPR of US. Patent No. 7,668,730
`Page 4 of 11
`
` PAR1020
`IPR of U.S. Patent No. 7,668,730
` Page 4 of 11
`
`
`
`7/2/2014
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`C DER 2001 Advisory Committee Meeting Documents
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`367711,nf(561)
`
`Slides
`37405 1 .htm
`
`Agenda
`3677a1.m, pdf
`
`3677t1_01.pfi1' (6421)
`3677t] 32¢ (6733)
`3677t1_03.pdf (2448)
`
`02/08
`
`3677t2_01.pdf (6774)
`3677t2_02. df (6852)
`3677t2_03. df (2918)
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`3677t2.1tf (597)
`
`
`
`Roster
`
`3677r1_01.m, mif
`
`Guest Roster
`
`3677r1_02.m, @‘
`
`Briefing Information
`3677b1.ht_m
`
`Questions
`3677mm, mf
`
`Slides
`
`3677sl.ht_m
`
`Briefing Package
`3677b2.htm
`
`Agenda
`3677a2.d0c & pdf
`
`Questions
`367792 01.d0c & fl
`3677 2_02.doc & pdf
`
`Slides
`
`| Top
`
`Caidiovas cular and Renal—Drugs Advisory Committee
`
`367752.ht_m
`
`08/09
`
`08/09 Pages 1- 100
`377511_01,pdf
`
`3—775t1.11:f (444)
`
`Pages 101-200
`3775t1 02.pdf
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`Pages 201-300
`3775t1_03.pdf
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`Pages 301-400
`3775t1 04.pdf
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`Pages 401-411
`3775t1_05.pdf
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`https://web.archive.org/webl20011004081740/http://V\MAN.fda.g ov/ohrms/dockets/ac/cderm .htm
`
`Agenda
`3775a1.m_, nd_f
`
`Roster
`3775rl.htm
`
`Briefing Information
`3775bl.htm
`
`Que stions
`Re mondulin
`
`3775ql_01.1fl',
`
`ht_m
`
`Extraneal
`
`3775ql_02.pdf,
`
`Slides
`
`5/11
`
`PAR1020
`
`IPR of US. Patent No. 7,668,730
`Page5of11
`
` PAR1020
`IPR of U.S. Patent No. 7,668,730
` Page 5 of 11
`
`
`
`7/2/2014
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`C DER 2001 Advisory Committee Meeting Documents
`
`08/10 Pages 1- 100
`377512_01,pdf
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`3775t2.1tf (299)
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`3775s 1.htm
`
`Briefing Information
`3775h2,htm
`
`Pages 101-200
`3775t2 02.
`(if
`
`Pages 201-228
`3775t2_03. df
`
`3749t1_01.1Ldf (9171)
`3749t1_02.1Ldf (8690)
`3749t1_03.1Ldf (7469)
`3749t1_04.pdf (4025)
`
`5/24
`
`5/24
`
`3749t1.lf (437)
`
`376lsl.htm
`
`3775q2.pdf, ht_m
`
`Briefing Information
`3749b1.ht_m
`
`Agenda
`3749a1.ndL& hm
`
`Questions
`3749ql.fl& ht_m
`
`Briefing Information
`3749b2.ht_m
`
`Questions
`3749q2.fl& ht_m
`
`Notice of Meeting
`June 8, 2001 m pif
`
`Agenda
`3761a1.@, ht_m
`
`Questions
`
`3761ql.;flf, ht_m
`
`Briefing Information
`376lb1.ht_m
`
`Slides
`
`5/25
`
`3749t2_01.1Ldf (9171)
`3749t2_02.1Ldf (8465)
`3749t2_03.p_df (8352)
`3749t2_04.1Ldf (7345)
`
`3749t2.fi (465)
`
`Endocrinologic and Metabolic Drugs Advisory Committee
`
`07/26
`
`07/26 Pages 1- 100
`3761t1_01. df (9,446)
`
`3—.761t1htm
`
`3761m1 Ldf & h_tm
`
`Pages 101-200
`3761t1 02. df(9,613)
`
`Pages 201-300
`3761t1_03. df (9,586)
`
`Pages 301-342
`3761t1_04. df(8,306)
`
`3761a24fl‘, ht_m
`
`Questions
`3761q2-mf, ht_m
`
`Roster
`
`3761r2.pdf, ht_m
`
`Briefing Information
`3761b2.ht_m
`
`6/11
`
`PAR1020
`
`IPR of US. Patent No. 7,668,730
`Page 6 of 11
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`3761t2.htm
`
`3761m2.pdf & ht_m
`
`Pages 1-100
`3761t2 01 df(8,398)
`
`L P
`
`ages 101-200
`3761t2 02 (if (8,508)L
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`Pages 201-300
`3761t2 03 df(8,318)L
`
`Pages 301-359
`3761t2 04 (if (9,991)L
`
`https://web.archive.org/webl20011004081740/http://V\MAN.fda.g ov/ohrms/dockets/ac/cderm .htm
`
` PAR1020
`IPR of U.S. Patent No. 7,668,730
` Page 6 of 11
`
`
`
`7/2/2014
`
`| Top
`
`C DER 2001 Advisory Committee Meeting Documents
`
`Slides
`3761t2.htm
`
`Nonprescription Drugs Advisory Committee
`
`05/11
`
`05/11 Pages 1- 100
`3737t1_01. df
`
`3737t1.rt_f
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`3737m1.pdf, h_tml
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`Pages 101-200
`3737t1_02. df
`
`Pages 201-300
`3737t1_03. df
`
`Pages 301-345
`3737t1 04. df
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`3782t1 02c. df (2,226) Agenda
`
`Agenda
`3737a1.ht_m, fl
`
`Planning Agenda
`3737a1_planning.ht_m,
`Ifl
`
`Questions
`3737q1.m_m, 11%
`
`Briefing Information
`3737bl.htm
`
`Petition
`
`3782a1 .p_fd& h_tm
`Revised Agenda
`3782a1_revised.p_fd&
`
`3782r1 .p_f & h_tm
`Consultants
`
`3782r1_consultants.1fl
`& h_tm
`
`Questions
`3782q1.1Ldf & h_tm
`Intradose 3782q1_02. {fl
`& h_tm
`
`Briefing Information
`3782b1.htm
`
`Oncologic Drugs Advisory Committee
`
`09/10
`
`09/10 Morning Session Pages Morning Session
`1 100 3782t1_01a.pdf
`3782t1_01.htm (139)
`(10,008) Pages 101-179
`3782t1 01b. df
`
`Afternoon Session
`3782t1_02.htm
`
`Afternoon Session Pages
`1100 3782t1 023.pdf
`(9,796) Pages 101-200
`3782t1 02b. df (9,878)
`Pages 201-225
`
`3782t2.htm
`
`09/11 Pages 1-100
`3782t2 01.pdf Pages
`101-200 3782t2 02.pdf
`Pages 201-239
`3782t2 03.pdf
`_
`
`https://web.archive.org/webl20011004081740/http://\/1MAN.fda.gov/ohrms/dockets/ac/cderm.htm
`
`Slides 3178251.th
`
`Briefing Information
`3782b2.htm
`
`Questions
`3782q2_zevalin-mf &
`ht_m
`
`7/1 1
`
`PAR1020
`
`IPR of US. Patent No. 7,668,730
`Page 7 of 11
`
` PAR1020
`IPR of U.S. Patent No. 7,668,730
` Page 7 of 11
`
`
`
`7/2/2014
`
`CDER 2001 Advisory Committee Meeting Documents
`
`Slides 3782s2.htm
`
`06/28
`
`06/28 Pages 1-100
`
`._,
`
`._
`
`Pe diatric Subcommittee
`
`06/07
`
`06/07 Pages 1-100
`3757t1_01. df
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`3757mm, ht_m
`
`4/24
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`4/24
`
`3743t1_01 ILdf
`3743t1_02.1Ldf
`3743t1_03.1Ldf
`
`Pe diatric Subcommittee
`
`3743t1.lf
`
`Peripheral & Central Nervous System Drugs Advisory Committee
`
`Agenda
`3756a1.ht_ma13d_f
`
`Roster
`
`3756r1.th, p_df
`
`Briefing Information ht_m
`& fl
`
`Slides
`
`3756sl.ht_m
`
`Agenda
`3757a1.ht_m & fl
`
`Questions
`3757q1.ht_m & fl
`
`Briefing Information
`3757b1.ht_m & pdf
`
`Agenda
`3743a1.ht_m & {fl
`
`Roster
`
`3743rl.th, p_df
`
`Briefing Information
`3743b1.ht_m & fl
`
`Slides
`
`374351.ht_m
`
`6/6
`
`Pages 1- 100
`3754t1_01.1Ldf
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`3—.754t1txt
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`3754m1.1fl', h_tml
`
`Pages 101-200
`3754t1_02.1Ldf
`
`Pages 201-300
`3754t1_03.1Ldf
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`Pages 301-381
`3754t1_04.lfif
`
`https://web.archive.org/webl20011004081740/http://V\MAN.fda.gov/ohrms/dockets/ac/cderm.htm
`
`Agenda
`3754a1.pdf, html
`
`Rosters
`Members 3754r1_01.1fl.
`html
`
`Consultants
`3754r1_02.1Ldf, html
`
`Public Hearing
`3754rl_03.1Ldf. html
`
`Questions
`3754q1.[fif, html
`
`8/1 1
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`PAR1 020
`
`IPR of US. Patent No. 7,668,730
`Page 8 of 11
`
` PAR1020
`IPR of U.S. Patent No. 7,668,730
` Page 8 of 11
`
`
`
`7/2/2014
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`C DER 2001 Advisory Committee Meeting Documents
`
`3/13
`
`3/13
`
`3724t1.lfl‘
`
`3724tl .fl
`
`3724m1.ht_m
`
`3742m1.1fl'
`
`Briefing Information
`3754bl.ht_m
`
`Slides
`
`3754sl.hfl
`
`Agenda
`3724a1.fl, @
`
`Roster
`
`3724r1_01.d9_c, mLf
`
`
`
`3724t2.lfl'
`
`I3/14
`
`| Top
`
`3724t2.1f
`
`3724m2.ht_m
`
`3724m2.Ldf
`
`Agenda (DRAFT)
`3724a2.m, fl
`
`
`
`Briefing Info
`3724bl.ht_m
`
`Slides
`
`3724sl.hfl
`
`Roster
`
`3724r1_02.m, {fl
`
`Briefing Info
`3724b2.ht_m
`
`Slides
`
`372452.hfl
`
` Advisory Committee for Pharmaceutical Science
`
`
`
`07/19 07/19 Pages 1-100
`3763t1_01.pdf
`
`3763t1.ht_m, g 3763m1.ht_m & Agenda
`IL“
`3763a1.th & m
`
`Pages 101-200
`3763t1_02.pdf
`
`Pages 201-300
`3763t1_03.pdf
`
`Pages 301-313
`3763tl 04.pdf
`
`Roster
`
`3763rl.ht_m & pdf
`Guest Roster
`
`3763rl_guest.m
`& M
`FDA Roster
`
`37631'1_fda.m &
`1L“
`
`Questions
`3763q2.ht_m &
`1L“
`
`B riefing
`Information
`
`3763bl .ht_m
`
`https://web.archive.org/webl20011004081740/http://\/\MAN.fda.g ov/ohrms/dockets/ac/cderm .htm
`
`9/11
`
`PAR1020
`
`IPR of US. Patent No. 7,668,730
`Page90f11
`
` PAR1020
`IPR of U.S. Patent No. 7,668,730
` Page 9 of 11
`
`
`
`7/2/2014
`
`C DER 2001 Advisory Committee Meeting Documents
`
`Slides
`
`376351.ht_m
`
`7/20 Pages 1-100
`.
`
`3763t2.hfl, m 3763m2.hfl & Agenda
`3763a2.ht_m & pi
`
`Guest Roster
`
`.
`
`37631‘2_guest.m
`& 1L“
`FDA Roster
`
`3763r2_fda.m &
`
`Slides
`
`376352.ht_m
`
`Orally Inhaled and Nasal Drug Products Subcommittee
`
`3742b1.th & pi
`
`7/17
`
`7/17 Pages 1-100
`3764t1_01. df
`
`3764t1.ht_m, M
`
`Pages 201-211
`3764tl_03,pdf
`
`Non-Chmcal Studles Subcomm1ttee
`
`5/3
`
`Agenda
`3764a1.ht_m & pi
`
`Roster
`
`3764r1.ht_m & lLdf
`
`Open Speakers
`3764r1.hfl & pd_f
`
`Questions
`3764ql.ht_m &
`1L“
`
`Briefing
`Information
`
`3764bl.ht_m
`
`Slides
`
`3764sl.ht_m
`
`Agenda
`3742a1.ht_m & mif
`
`Roster
`
`3742r1.ht_m & fl
`37421'2.ht_m & pdf
`
`Briefing Info
`
`| Top
`
`Psychopharmacologic Drugs Advisory Committee
`I
`https://web.archive.org/webl20011004081740/http://\/\MAN.fda.gov/ohrms/dockets/ac/cderm.htm
`
`I
`10/1 1
`
`PAR1020
`
`IPR of U.S. Patent No. 7,668,730
`Page 10 of 11
`
` PAR1020
`IPR of U.S. Patent No. 7,668,730
` Page 10 of 11
`
`
`
`7/2/2014
`
`C DER 2001 Advisory Committee Meeting Documents
`
`2/14
`
`2/14
`
`3685t1.fl
`
`3685t1t_xt
`
`3685m1.Ldf
`
`2/15
`
`3685t2.m
`
`3685t2t_xt
`
`3685m2.pd
`
`Agenda
`3685a1.d9_capdi
`
`Roster
`
`3685rl.fl, pdf
`
`Questions
`3685q1.m, pi
`
`Briefing Info
`3685bl.ht_m
`
`Slides
`
`36855 LE
`
`Agenda
`3685a2.ma pi
`
`Roster
`
`3685r2.M, p_df
`
`Questions
`
`3685q2.ma1fl
`
`Briefing Info
`3685b2.ht_m
`
`Slides
`
`368552.mI_n
`
`Agenda
`3737al.ht_m, pdf
`
`Planning Agenda
`3737a1_planning.ht_m,
`fl
`
`Questions
`3737q1.ht_m, fl
`
`Briefing Information
`3737hl,htm
`
`m |
`
`3737t1.fl
`
`3737m1.1fl, html
`
`Top
`
`(Updated 10/02/01 )
`
`https://web.archive.org/webl20011004081740/http://\/\MAN.fda.g ov/ohrms/dockets/ac/cderm .htm
`
`11/1 1
`
`PAR1020
`
`IPR of U.S. Patent No. 7,668,730
`Page 11 of 11
`
` PAR1020
`IPR of U.S. Patent No. 7,668,730
` Page 11 of 11
`
`
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