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2007N-0005: Prescription Drug User Fee Act (PDUFA): Public Meeting

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
NM1 01/11/2007 FDA FDA 01/16/2007 1743-1753 02/23/2007 htm pdf Registration due 2/2/2007
Signature: Jeffrey Shuren
EC1 01/19/2007 01/16/2007 Drug Industry Strides Inc. htm
Signature: Riebling, Peter
LST1 02/13/2007 02/13/2007 Federal Government
Agenda for February 16, 2007 Public Meeting htm
TS1 02/20/2007 02/20/2007 Federal Government
Prescription Drug User Fee Act (PDUFA IV) pdf
ppt
TS2 02/20/2007 02/20/2007 Federal Government
FDA - User-Fee Funding of Human Drug Review pdf
ppt
Reauthorization of the Prescription Drug User Fee Act
Signature: Janet Woodcock, MD
TS3 02/20/2007 02/20/2007 Individual Consumer K Witczak pdf Testimony
TS4 02/20/2007 02/20/2007 Consumer Group Consumers Union pdf Testimony
Signature: William Vaughan
TS5 02/20/2007 02/20/2007 Association Plasma Protein Therapeutics Association (PPTA) pdf Testimony
Signature: Mary Gustafson
TS6 02/20/2007 02/20/2007 Association U S Chamber of Commerce pdf Testimony
Signature: Anthony C Wisniewsky
TS7 02/20/2007 02/20/2007 Consumer Group Committee of Ten Thousand pdf Testimony
Signature: David Cavenaugh
TS8 02/20/2007 02/20/2007 Association AHRP pdf Testimony
Signature: Ellen Liversidge
TS9 02/20/2007 02/20/2007 Association Coalition for Healthcare Communication pdf
ppt
Testimony
Signature: John Kamp
TS10 02/20/2007 02/20/2007 Private Industry Biotechnology Industry Organization pdf
ppt
Testimony
Signature: Alison Lawton
TS11 02/20/2007 02/20/2007 Private Industry Academy of Managed Care Pharmacy pdf
ppt
Testimony
Signature: Judith A Cahill
TS12 02/20/2007 02/20/2007 Private Industry Drug Safety Institute pdf
ppt
Testimony
Signature: Lil Stiver RPh
TS13 02/20/2007 02/20/2007 Private Industry Biotechnology Industry Organization pdf Testimony
TS14 02/20/2007 02/20/2007 Consumer Group National Research Center for Women & Families pdf Testimony
Signature: Diana Zuckerman PhD
TS15 02/21/2007 02/21/2007 Association American Society of Health-Systems Pharmacists
html
pdf
Testimony
Signature: Brian M Meyer
TS16 02/21/2007 02/21/2007 Private Industry Mental Health America html
pdf
Testimony
Signature: David Fassler
TS17 02/21/2007 02/21/2007 Private Industry Council on Radionuclides and Radiopharmaceuticals (CORAR)
html
pdf
Testimony
Signature: Alan Kirschenbaum
TS18 02/21/2007 02/21/2007 Individual Consumer W DeCamp html
pdf
Testimony
SUP1 02/22/2007 02/22/2007 Association Coalition for Healthcare Communication pdf Revised Testimony
Signature: John Kamp
TS19 02/22/2007 02/22/2007 Association Pharmaceutical Research and Manufacturers of America (PhRMA)
pdf Testimony
Signature: Alan Goldhammer, PhD
TS20 02/22/2007 02/22/2007 Individual Consumer Parkinson Pipeline Project html
pdf
Testimony - A Patient's Perspective on Key Policy Issues for User Fees and Drug Safety Legislation
Signature: Perry D Cohen PhD
EC2 02/22/2007 02/19/2007 Consumer Group Consumers Union htm No attachment received
Signature: Vaughan, William
EC3 02/22/2007 02/20/2007 Health Care Association
ISPE htm
Signature: Epstein, Mark
EC4 02/22/2007 02/21/2007 Health Professional Dr. Alan Wasserman htm
TS21 02/23/2007 02/23/2007 Association Friends of Cancer Research pdf Testimony
Signature: Jeff Allen PhD
C1 02/23/2007 02/22/2007 Association National Health Council pdf
Signature: Marc Boutin
EC5 02/26/2007 02/22/2007 Health Care Association
American College of Clinical Pharmacy htm
Signature: McGlew, John
EC6 02/26/2007 02/22/2007 Other Organization AARP pdf
Signature: Certner, David
EC13 02/26/2007 02/23/2007 Association American Association of Colleges of Pharmacy pdf
Signature: Lang, William
EC14 02/26/2007 02/23/2007 Drug Association Pharm Res & Mfrs of America pdf
Signature: Goldhammer, Alan
EC15 02/26/2007 02/23/2007 Health Professional National Alliance of Medical Researchers pdf
Signature: Charles, David
EC16 02/26/2007 02/23/2007 Consumer Group National Alliance on Mental Illness pdf
Signature: Sperling, Andrew
EC17 02/26/2007 02/23/2007 Health Care Association
National Organization for Rare Disorders (NORD) pdf
Signature: Meyers, Abbey
EC18 02/26/2007 02/23/2007 Health Care Association
American Pharmacists Association (APhA) pdf
Signature: Gans, John
EC19 02/26/2007 02/23/2007 Health Care Association
National Organization for Rare Disorders (NORD) No Attachment received
Signature: Meyers, Abbey
EC20 02/26/2007 02/23/2007 Consumer Group CENTER FOR MEDICAL CONSUMERS pdf
Signature: LEVIN, ARTHUR
EC21 02/26/2007 02/23/2007 Academia University of Pennsylvania CERT pdf
Signature: Hennessy, Sean
EC22 02/26/2007 02/23/2007 Drug Industry Council on Radionuclides and Radiopharmaceuticals
pdf
Signature: Kirschenbaum, Alan
EC23 02/26/2007 02/23/2007 Consumer Group National Consumers League pdf
Signature: Golodner , Linda
EC24 02/26/2007 02/23/2007 Consumer Group FasterCures pdf
Signature: Simon, Greg
EC25 02/26/2007 02/23/2007 Other Organization Elizabeth Glaser Pediatric AIDS Foundation Attachments: 1.pdf, 2.pdf
Signature: Thompson, Diane
EC26 02/26/2007 02/23/2007 Consumer Group Ms. Margaret Anderson No attachment received
EC27 02/26/2007 02/23/2007 Health Care Association
The ALS Association pdf
Signature: Gibson, Steve
EC28 02/26/2007 02/23/2007 Other Organization National Research Center for Women & Families pdf
Signature: Zuckerman, Diana
C2 02/26/2007 02/26/2007 Private Industry Sepracor pdf
Signature: Stewart H. Mueller
C3 03/01/2007 02/27/2007 Private Industry Pain Therapeutics, Inc. pdf
Signature: Stephen E. Johnson