This has turned out to be more trouble than it may be worth....6 pages of FDA pdf disappeared for a while:
Manufacturer Communications Regarding Unapproved Uses of
Approved or Cleared Medical Products
Part 15 Public Hearing, November 9-10, 2016
FDA White Oak Campus
10903 New Hampshire Ave, Building 31, Room 1503
Silver Spring, Maryland 20993
WEDNESDAY, 9 NOVEMBER
9:00 – 9:10 a.m. Welcome and Administrative Announcements
Leslie Kux, Associate Commissioner for Policy
9:10 – 9:25 a.m. Opening Remarks
Dr. Robert Califf, Commissioner
PRESENTATIONS
Each individual presenter has been allotted 8 minutes; joint presenters have been allocated 16 minutes. Following each
presentation, FDA panel members will have a brief opportunity to ask clarifying questions.
9:25 – 9:33 a.m. Mr. Michael Labson
Covington & Burling LLP, on behalf of Pharmaceutical Research and Manufacturers of America
(PhRMA)
9:35 – 9:43 a.m. Ms. E. Cartier Esham
Biotechnology Innovation Organization (BIO)
9:45 – 9:53 a.m. Ms. Khatereh Calleja
Advanced Medical Technology Association (AdvaMed)
9:55 – 10:11 a.m. Ms. Kellie Combs and Ms. Coleen Klasmeier
Medical Information Working Group (MIWG)
10:13 – 10:21 a.m. Mr. James Czaban
DLA Piper LLP (US)
10:23 – 10:31 a.m. Mr. Daniel Biank
DuVal & Associates, P.A.
10:33 – 10:50 a.m. MORNING BREAK – next presentation starts promptly at 10:50 a.m.!
10:50 – 10:58 a.m. Ms. Sandra Kalter
Medtronic PLC
11:00 – 11:08 a.m. Dr. Andrew Koenig
Pfizer Inc.
11:10 – 11:18 a.m. Ms. Danelle Miller
Roche Diagnostics
11:20 – 11:28 a.m. Dr. Sandra Milligan
Merck
11:30 – 11:38 a.m. Mrs. Penny Levin
Teva Pharmaceuticals
11:40 – 11:48 a.m. Dr. Edith Perez
Genentech
Manufacturer Communications Regarding Unapproved Uses of
Approved or Cleared Medical Products
Part 15 Public Hearing, November 9-10, 2016
DRAFT VERSION 10.31.2016 – Please note this agenda is subject to change
WEDNESDAY, 9 NOVEMBER (continued)
11:50 – 11:58 a.m. Mr. Frank Wilton
American Association of Tissue Banks (AATB)
12:00 – 12:08 p.m. Mr. Nicodemo Fiorentino
G&M Health, LLC
12:10 – 12:18 p.m. Ms. Zoe Dunn
Hale Advisors
12:20 – 12:28 p.m. Ms. Tracy Rockney
OneSource Regulatory
12:30 – 1:30 p.m. LUNCH BREAK – next presentation starts promptly at 1:30 p.m.!
A la carte items will be available for purchase on site.
1:30 – 1:38 p.m. Dr. Samuel Nussbaum
Anthem, Inc.
1:40 – 1:48 p.m. Mr. Michael Hoak
Humana
1:50 – 1:58 p.m. Ms. Jennifer Graff
National Pharmaceutical Council
2:00 – 2:08 p.m. Dr. Soumi Saha
Academy of Managed Care Pharmacy
2:10 – 2:18 p.m. Dr. Vikas Saini
The Lown Institute
2:20 – 2:28 p.m. Mr. John Mack
Pharma Marketing News
2:30 – 2:38 p.m. Dr. John Kamp
Coalition for Healthcare Communication
2:40 – 2:48 p.m. Mr. Gregory Herbers
Washington Legal Foundation
2:50 – 2:58 p.m. Mr. Ralph Hall
University of Minnesota Law School and Leavitt Partners
3:00 – 3:15 p.m. AFTERNOON BREAK – next presentation starts promptly at 3:15 p.m.!
3:15 – 3:23 p.m. Dr. William Welch
American Association of Neurological Surgeons/Congress of Neurological Surgeons
(AANS/CNS)
3:25 – 3:33 p.m. Mr. Jeremy Lew
Individual Stakeholder
3:35 – 3:43 p.m. Ms. Sandra Raymond
Lupus Foundation of America
Manufacturer Communications Regarding Unapproved Uses of
Approved or Cleared Medical Products
Part 15 Public Hearing, November 9-10, 2016
DRAFT VERSION 10.31.2016 – Please note this agenda is subject to change
WEDNESDAY, 9 NOVEMBER (continued)
3:45 – 3:53 p.m. Mr. Stephen Marmaras
Global Healthy Living Foundation
3:55 – 4:03 p.m. Mr. Paul Melmeyer
National Organization for Rare Disorders
4:05 – 4:13 p.m. Dr. Aaron Kesselheim
Brigham and Women's Hospital and Harvard Medical School
4:15 – 4:23 p.m. Dr. Sidney Wolfe
Public Citizen's Health Research Group
4:25 – 4:33 p.m. Dr. Michael Carome
Public Citizen's Health Research Group
4:35 – 4:43 p.m. Mr. Robert Weissman
Public Citizen
4:45 – 4:53 p.m. Dr. Doris Peter
Consumer Reports
4:55 – 5:00 p.m. Day one closing remarks
Leslie Kux
5:00 p.m. Adjournment
Manufacturer Communications Regarding Unapproved Uses of
Approved or Cleared Medical Products
Part 15 Public Hearing, November 9-10, 2016
DRAFT VERSION 10.31.2016 – Please note this agenda is subject to change
THURSDAY, 10 NOVEMBER
9:00 – 9:10 a.m. Opening Remarks
Leslie Kux
9:10 – 9:18 a.m. Dr. Joshua M. Sharfstein
Johns Hopkins Bloomberg School of Public Health
9:20 – 9:28 a.m. Mr. Steve Francesco
Do No Harm Network
9:30 – 9:38 a.m. Ms. Kim Witczak
WoodyMatters
9:40 – 9:56 a.m. Ms. Robyn Edwards and Ms. Veverly Edwards
Consumers Union Safe Patient Project
9:58 – 10:06 a.m. Ms. Lisa Gill
Consumer Reports
10:08 – 10:16 a.m. Dr. Yanling Yu
Washington Advocates for Patient Safety
10:18 – 10:26 a.m. Dr. Stephanie Fox-Rawlings
Patient, Consumer, and Public Health Coalition
10:28 – 10:36 a.m. Dr. Diana Zuckerman
National Center for Health Research
10:38 – 10:46 a.m. Ms. Melayna Lokosky
Individual Stakeholder
10:48 – 11:10 a.m. MORNING BREAK – next presentation starts promptly at 11:10 a.m.!
11:10 – 11:18 a.m. Dr. Margaret McCarthy
Yale Law School
11:20 – 11:28 a.m. Ms. Jeanie Kim
Yale Law School
11:30 – 11:38 a.m. Ms. Amy Kapczynski
Yale Law School
11:40 – 11:56 a.m. Dr. Lisa M. Schwartz and Dr. Steven Woloshin
The Dartmouth Institute for Health Policy and Clinical Practice
11:58 – 12:06 p.m. Ms. Joy Eckert
George Washington University
12:08 – 12:24 a.m. Ms. Kimberly A. Dougherty and Ms. Cara Jones
Janet, Jenner & Suggs LLC
12:26 – 1:30 p.m. LUNCH BREAK – next presentation starts promptly at 1:30 p.m.!
A la carte items will be available for purchase on site.
Manufacturer Communications Regarding Unapproved Uses of
Approved or Cleared Medical Products
Part 15 Public Hearing, November 9-10, 2016
DRAFT VERSION 10.31.2016 – Please note this agenda is subject to change
THURSDAY, 10 NOVEMBER (continued)
1:30 – 1:38 p.m. Dr. Adriane Fugh-Berman
Georgetown University Medical Center
1:40 – 1:48 p.m. Ms. Alycia Hogenmiller
Georgetown University Medical Center
1:50 – 1:58 p.m. Dr. Rebecca Jones
Individual Stakeholder
2:00 – 2:08 p.m. Dr. Doyle Stulting
American Society of Cataract and Refractive Surgery (ASCRS) and the Alliance of Specialty
Medicine
2:10 – 2:26 p.m. Mrs. Katherine McGahey and Ms. Lauren Brown
1 Million 4 Anna Foundation
2:28 – 2:44 p.m. Mrs. Sarah Christopherson and Ms. Christina Cherel
National Women’s Health Network
2:46 – 2:54 p.m. Ms. Amy Leitman
NTM Info & Research
2:56 – 3:15 p.m. AFTERNOON BREAK – next presentation starts promptly at 3:15 p.m.!
3:15 – 3:23 p.m. Dr. Adelaide Robb
Children’s National
3:25 –3:33 p.m. Mr. Andrew Sperling
National Alliance on Mental Illness
3:35 – 3:43 p.m. USA Patient Network
3:45 – 3:53 p.m. Dr. Megan Coder
Pharmaceutical Care Management Association (PCMA)
3:55 – 4:03 p.m. Mrs. Brigett Whitted
Individual Stakeholder
4:05 – 4:13 p.m. Mr. Mychal Wilson
Whistleblower Attorney
4:15 – 4:54 p.m. OPEN PUBLIC COMMENTS
Multiple 3-minute speaker slots will be available on a first-come, first-served basis. Please sign
up for a slot at the registration table prior to the end of the LUNCH BREAK at 1:30.
4:55 – 5:00 p.m. Closing Remarks
Leslie Kux
5:00 p.m. Adjournment
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