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56 documents found matching dt:minutes*.
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Showing 1-10 of 56 documents
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1.
Parke-Davis Internal Minutes: Parke-Davis/FDA Neuropharmacological Drug Products Meeting Neurontin Monotherapy Non-Approvable Letter
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Document Date:
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19970918
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Author:
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Turner, Janeth L
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Corporate Author:
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Parke-Davis
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CONFIDENTIAL
I.
Parke-Davis Internal Minutes
Parke-Davis/FDA Neuropharmacologocial Drug Products Meeting
Neurontin Monotherapy Non-Approvable Letter
September 18, 1997
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FDA Attendees
Dr. Paul Leber, Division Director
Dr. Russ.Katz, Deputy Division Director
Dr. Bob Rappaport, Medical Reviewer
Dr. Ranjit Mani, Medical Reviewer
Dr. Todd Sahlroot, Statistician
Ms. Melina Malandrucco, CSO
PD Attendees
Dr. Bob Zerbe, Sr. VP, Clinical Research
Dr. Mark Pierce, VP, Clinical Research, CNS
Dr. Betsy Garofalo, Sr; Director, Clinical Research, CNS
Ms. Jan Turner, Director, Regulatory Affairs
Dr. Irwin Martin, VP, Regulatory Affairs
Background
Parke-Davis submitted a supplement to the approved Neurontin NDA 20-235 on
September 13, 1996 to support an indication of monotherapy in refractory and newly
diagnosed patients. On August 26, 1997 we received a non-approvable letter for the
monotherapy indication. This meeting was held to discuss what needs to be done
before this sNDA may be approved.
Summary
Because mon
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http://dida.library.ucsf.edu/tid/gcb00a10
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2.
Telecon Minutes [re: Labeling Negotiations]
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Document Date:
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20020130
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Corporate Author:
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Merck Research Laboratories
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TELECON MINUTES
MEETING DATE: January 30, 2002 TIME: 08:30 a.m. LOCATION: Corp S300
NDA 21-042/S-007, 012 Telecon Request Date; December 19, 2001
NDA 21-052/5-004, 007 Telecon Cancelled by Sponsor: January 07, 2002
Telecon Rescheduled: January 17, 2002
DRUG: Vioxx (rofecoxib) Tablets 12.5 mg, 25 mg, 50 mg
Vioxx (rofecoxib) Suspension 12.5 mg/5 mL, 25mg/5 mL
' SPONSOR/APPLICANT: Merck Research Laboratories
TYPE of TELECON: Labeling Negotiations
FDA PART] CIPANTS:
Jonca C. Bull, MD
Lany Goldkind, MD
James Witter, MD, Ph.D.
Maria L. Villalba, MD
Joel Schiffenbauer, MD
Stan Lin, Ph.D.
Carmen DeBellas, R.Ph.
Barbara Gould Robert Temple, MD
Laura Govemale
Division of Anti-lnflammatory, Analgesics, & Ophthalmic Drug Product
Acting Director, Deputy Director, Office of Drug Evaluation V
Deputy Division Director
Acting Medical Team Leader
Medical Reviewer
Medical Reviewer
Biostatistics Team Leader
Chief, Project Management Staff
Project Manager
Director, Office of Medical Policy
Project Manager, Office of Medical Pol
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http://dida.library.ucsf.edu/tid/tjb00a10
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3.
Telecon Minutes [re: Labeling Negotiations]
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Document Date:
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20020208
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Corporate Author:
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Merck Research Laboratories
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--TELECON MINAJT-ES
0
MEETING DATE: February 08, 2002 TIME: 1:30 P.M. LOCATION: Corp S300
NDA 21-042/S-007, 012
NDA 21-052/5-004,007
DRUG: Vioxx (rofecoxib) Tablets 12.5 mg, 25 mg, 50 mg
Vioxx (rofecoxib) Suspension 12.5 mg/5 mL, 25mg/5 ml,
SPONSORtAPPLICANT: Merck Research Laboratories
TYPE of TELECON: Labeling Negotiations
FDA PARTICIPANTS:
Jonca C. Bull, MD
Lany Goldkind, MD
James Winer, MD, Ph.D.
Maria L. Villalba, MD
Joel Schiffenbauer, MD
Lisa Hubbard, RPh.
Barbara Gould
Division of Anti-Intlammatory, Analgesics, & Ophthalmic Drug Product
Acting Director, Deputy Director, Office of Drug Evaluation V
Deputy Division Director
Acting Medical Team Leader
Medical Reviewer
Medical Reviewer
Labeling Reviewer
Project Manager
INDUSTRY PARTICIPANTS:
Dr. Bonnie Goldmann
Dr_ Robert Silverman
Dr. Ned Braunstein
Dr. Diane Benezra
Ms. Dawn Chitty
Dr. Alise Reicin
Dr. Kenneth Truitt
Dr. Thomas Simon
Dr. Barry Gertz
Dr. Deborah Shapiro
Mr. James Bolognese
Dr. Leonard Oppenheimer
Dr. Douglas Watson
Dr. Harry Guess
Dr.
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http://dida.library.ucsf.edu/tid/ujb00a10
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4.
Telecon Minutes [re: Labeling Negotiations]
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Document Date:
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20020220
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Corporate Author:
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Merck Research Laboratories
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1-U`I-Es
0
0
MEETING DATE: February 20, 2002 TIME: 1:30 P.M. LOCATION: Corp N351
NDA 21-042/S-007, 012
NDA 21-052/S-004, 007
DRUG: Vioxx (rofecoxib) Tablets 12.5 mg, 25 mg, 50 mg
Vioxx (rofecoxib) Suspension 12.5 mg/5 mL, 25mg/5 mL
SPONSOR/APPLICANT: Merck Research Laboratories
TYPE of TELECON: Labeling Negotiations
FDA PARTICIPANTS:
Jonca C. Bull, MD
Larry Goldldnd, MD
James Witter, MD, Ph.D.
Maria L_ Villalba, MD
Joel Schiffenbauer, MD
Lisa Hubbard, RPh.
Barbara Gould
Division of Anti-Inflammatory, Analgesics, & Ophthalmic Drug Product
Acting Director, Deputy Director, Office of Drug Evaluation V
Deputy Division Director
Acting Medical Team Leader
Medical Reviewer
Medical Reviewer
Labeling Reviewer
Project Manager
INDUSTRY PARTICIPANTS:
Dr. Bonnie Goldmann
Dr. Robert Silverman
Dr. Ned Braunstein
Dr. Diane Benezra
Ms. Dawn Chitty
Dr. Alise Reicin
Dr. Kenneth Truitt
Dr. Thomas Simon
Dr. Barry Gertz
Dr. Deborah Shapiro
Mr. James Bolognese
Dr. Leonard Oppenheimer
Dr. Douglas Watson
Dr. Harry Guess
Dr. Thomas Bo
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http://dida.library.ucsf.edu/tid/vjb00a10
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5.
Telecon Minutes [re: Labeling Negotiations]
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Document Date:
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20020307
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Corporate Author:
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Merck Research Laboratories
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0
MEETING DATE: March 07, 2002
NDA 21-042/S-007, 012
NDA 21-052/5-004, 007
ohT-MINUTES--
TIME: 2:00 P.M. LOCATION: Corp N351
DRUG: Vioxx (rofecoxib) Tablets 12.5 mg, 25 mg, 50 mg
Vioxx (rofecoxib) Suspension 12.5 mg/5 mL, 25mg/5 mL
SPONSORIAPPLICANT: Merck Research Laboratories
TYPE of TELECON: Labeling Negotiations
0 FDA PARTICIPANTS: Division of Anti-Inflammatory, Analgesics, & Ophthalmic Drug Product
Jonca C. Bull, MD Acting Director, Deputy Director, Office of Drug Evaluation V
Larry Goldkind, MD Deputy Division Director
Maria L. Vi]lalba, MD Medical Reviewer
Stan Lin, Ph.D. Biostatistics Team Leader
Lisa Hubbard, RPh. Labeling Reviewer
Barbara Gould Project Manager
Robert O'Neill, Ph.D Director, Office of Biostatistics (Joined the teleconference at 3:40 P.M.)
INDUSTRY PARTICIPANTS: Merck Research Laboratories
Dr_ Bonnie Goldmann
Dr. Robert Silverman
Dr. Ned Braunstein
Dr. Diane Benezra
Ms. Dawn Chitty
Dr. Alise Reicin
Dr. Kenneth Truitt
Dr. Thomas Simon
Dr. Barry Gertz
Dr. Deborah Shapiro
Mr. Ja
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http://dida.library.ucsf.edu/tid/wjb00a10
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6.
Telecon Minutes [re: Labeling Negotiations]
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Document Date:
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20020320
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Corporate Author:
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Merck Research Laboratories
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TELECON MINUTES
!'
TELECON DATE: March 20, 2002
NDA 27-042/S-007, 012
NDA 21-0521S-004, 007
TIME: 10:00 a.m. LOCATION: Corp S314
DRUG: Vioxx (rofecoxib) Tablets 12.5 mg, 25 mg, 50 mg
Vioxx (rofecoxih) Suspension 12.5 mg/5 mL, 25mg/5 mL
SPONSOR/APPLICANT: Merck Research Laboratories
TYPE of TELECON: Labeling Negotiations
FDA PARTICIPANTS:
Jonca C. Bull, MD
Larry Goldkind, MD
Maria L. Villalba, MD
Stan Lin, Ph.D.
Lisa Hubbard, RPh
Barbara Gould
Robert O'Neill, Ph.D.
Division of Anti-Inflammatory, Analgesics, & Ophthalmic Drug Product
Acting Director, Deputy Director, Office of Drug Evaluation V
Deputy Division Director
Medical Reviewer
Biostatistics Team Leader
Labeling Reviewer
Project Manager
Director, Office of Biostatistics
INDUSTRY PARTICIPANTS:
Dr. Bonnie Goldmann
Dr. Robert Silverman
Dr. Ned Braunstein
Dr. Diane Benezra
Ms. Dawn Chitty
Dr. Alise Reicin
Dr. Kenneth Truitt
Dr. Thomas Simon
Dr. Barry Gertz
Dr. Deborah Shapiro
Mr. James Bolognese
Dr. Leonard Oppenheimer
Dr. Douglas Watson
Dr. Harry Guess
D
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Bookmark:
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http://dida.library.ucsf.edu/tid/xjb00a10
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7.
MRL Meeting Minutes -- FDA CV Outcomes Teleconference
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Document Date:
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20040309
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Corporate Author:
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Merck & Co.
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MRL Meeting Minutes
IND 46, 894 Vioxx™ {Rofecoxib)
FDA CV Outcomes Teleconference
March 9,2004
MRL Attendees
James Bolognese, Clinical Bioslatislics Ned Braunstein, Regulatory Affairs Claudia Filauri, Regulatory Coordination Diane Louie, Regulatory Affairs Jennifer Ng, Biostalisties Alise Rei ein, Clinical Research Janet Van Adelsberg, Clinical
FDA Attendees
Barbara Gould, Project Manager Brian Harvey Sharon Hurst Dan Lin Jim Witter
The meeting began at 9:20a.m. There was a formal introduction by Mr. Ned Braunstein from Merck Research Laboratories (MRL), a Division of Merck & Co., Inc. The introduction gave a regulatory history of the meetings that have been held to discuss questions for Protocol 203 submitted for the Combination Analysis CV Outcomes for Vioxx vs. Placebo in October 2002. At that time, MRL submitted 9 questions lo the Agency and a response from the Agency followed in December 2002. MRL still had questions and a written request was therefore sent to the Agency for clarification. Anothe
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http://dida.library.ucsf.edu/tid/oxx04i10
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8.
Summary Minutes, Arthritis Advisory Committee
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Document Date:
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19990420
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Author:
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Reedy, Kathleen
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Corporate Author:
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FDA
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Search Terms in Context:
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Food and Drug Administration Center for Drug Evaluation and Research
SUMMARY MINUTES ARTHRITIS ADVISORY COMMITTEE
59 7 4 *99 JUL -1 P3S3
April 20, 1999
Holiday Inn Gaithersburg 2 Montgomery Village Avenue, Gaithersburg, MD
Members Present
Steven B. Abramson, M.D., Chair
Daniel J. Lovell, M.D., M.P.H.
David E. Yocum, M.D.
Leona Malone, MSW
Frank Pucino, Jr., Pharm.D.
Consultants
Ildy M. Katona, M.D. Janet D. Elashoff, Ph.D. Kevin R. McConnell, M.D.
Members Absent
E. Nigel Harris, M.D.
FDA Participants
Robert DeLap, M.D. John Hyde, M.D. Maria Lourdes Villalba, Mordechai Averbuch, M.D. Lawrence Goldkind, M.D. Juan Carlos Palayo, M.D. Susan D. Wilson, D.V.M., Dennis Bashaw, Pharm.D. Qian Li, Ph.D.
Guest Experts
James Scheiman, M.D. John Wallace, Ph.D.
M.D.
Ph.D.
Executive Secretary
Kathleen R. Reedy
These summary minutes for the April 20, 1999 meeting,-of the Arthritis Advisory Committee were approved on wptSifÇÇ
I certify that I attended the April 20, 1999 meeting of the Arthritis
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http://dida.library.ucsf.edu/tid/oxx01v10
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9.
MRL Meeting Handwritten Notes
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Document Date:
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20040309
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Corporate Author:
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Merck & Co.
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Search Terms in Context:
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Bookmark:
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10.
Premarin/TMG & 17 Beta/TMG Publication Team: Meeting Minutes, February 21, 2002
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Document Date:
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20020221
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Page Count:
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2
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PREMARIN/TMG & 17p/TMG PUBLICATION TEAM
Meeting Minutes February 21, 2002
In attendance
Wyeth Parthenon
D. Dubinsky J. Wright
P. Vinall T. Law
J. Gurr OCC
D. Downey R. Viola
S. Olivier C. Bendas
J. Baleva
Recap of January 18th meeting
R. Viola provided a brief summary of the first meeting of the full team: publication team objectives, Wyeth global and US marketing perspectives on the Women's Health franchise in general and TMG products in particular, status of the individual components of the TMG publication efforts (Parthenon, OCC), and the Wyeth manuscript approval process.
17P/TMG Publications
J. Wright provided the current priorities list and the lmg. and 2mg. status reports.
Discussion ensued on several topics with the following results
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http://dida.library.ucsf.edu/tid/xjc37b10
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