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Table 1. PDUFA IV Meetings – Technical Discussions with Regulated Industry Steering Group Meetings

Date Time Length	Subjects	Participants
10/25/05 4:00 to 5:00 PM 1 Hour	Upcoming PDUFA IV reauthorization PDUFA IV technical discussion steering group and technical groups Schedule of technical discussions Data on PDUFA trends Public accountability/Consultation on reauthorization	FDA: Theresa Mullin, OPPL Jane Axelrad, CDER (phone) Frank Claunts, OM Bob Yetter, CBER John Jenkins, CDER Malcolm Bertoni, OPPL Mark Gray, OCIO Fred Farmer, OCIO Paul Seligman, CDER (phone) Patricia Stewart, OPPL Ralph Lillie, CDER Ann Sullivan, OPPL David Horowitz, ORA PhRMA/BIO: Roy Baranello, Wyeth Andrew Emmett, BIO Donna Peterson, Amgen Alan Goldhammer, PhRMA Bob Pietrusko, Millennium Rachel Carle, Genzyme (phone) Scott Lassman, PhRMA Bruce Burlington, Wyeth Stacey Holdsworth, Eli Lilly Bill Rosen, Pfizer Lynne Tracey, Procter and Gamble Sharon Olmstead, Schering-Plough Kay Holcombe, Consultant to BIO Peter Loupos, Sanofi-Aventis (phone)
1/24/06 3:00 to 4:30 PM 1 ½ Hours	FDA responses to the industry's data request in preparation for the upcoming PDUFA IV reauthorization.	FDA: Theresa Mullin, OPPL Jane Axelrad, CDER Frank Claunts, OM Leonard Wilson, CBER John Jenkins, CDER Malcolm Bertoni, OPPL Ann Wion, OCC Fred Farmer, OCIO Deborah Henderson, CDER Robert Temple, CDER Ralph Lillie, CDER Nancy Boocker, CDER Michael Lanthier, CDER Patricia Stewart, OPPL PhRMA Alan Goldhammer, PhRMA Stacey Holdsworth, Eli Lilly Scott Lassman, PhRMA Jim Kotsanos, Eli Lilly Bill Rosen, Pfizer Gretchen Dieck, Pfizer Bruce Burlington, Wyeth Peter Loupos, Sanofi-Aventis Sharon Olmstead, Schering Plough Lynne Tracey, Procter & Gamble Don Sauer, Wyeth Steve Tilton, PhRMA BIO: Alison Lawton, Genzyme Corporation Roy Baranello, Wyeth Donna Peterson, Amgen Bob Pietrusko, Millennium Sara Radcliffe, BIO Andrew Emmett, BIO
2/14/06Teleconference 3:00 to 4:00 PM 1 Hour	Discuss industry request for data on PDUFA program and postmarket safety	FDA: Theresa Mullin, OPPL Jane Axelrad, CDER Deborah Henderson, CDER Ralph Lillie, CDER Patricia Stewart, OPPL Industry: Alan Goldhammer, PhRMA Sara Radcliffe, PhRMA Donna Peterson, BIO Andrew Emmett, BIO
3/16/06 1:00 to 4:00 PM 3 Hours	Discuss FDA versus industry perspectives on PDUFA reauthorization. The meeting concluded with agreement to hold more detailed discussions of specific issues in subsequent meetings of technical subgroups.	FDA: Theresa Mullin, OPPL Jane Axelrad, CDER Ann Wion, OCC Robert Yetter, CBER John Jenkins, CDER Malcolm Bertoni, OPPL Martha Louviere, OM Fred Farmer, OCIO Deborah Henderson, CDER David Horowitz, ORA Ralph Lillie, CDER Nancy Boocker, CDER John Gentile, OM Karen Meister, OL Patricia Stewart, OPPL PhRMA Alan Goldhammer, PhRMA Tricia de Santis, Johnson and Johnson Lynne Tracey, Procter & Gamble Sharon Olmstead, Schering Plough Bill Rosen, Pfizer Peter Loupos, Sanofi-Aventis Bruce Burlington, Wyeth Tony Rogers, AstraZeneca Scott Lassman, PhRMA Don Sauer, Wyeth Annetta Beauregard, Eli Lilly BIO: Alison Lawton, Genzyme Kay Holcome, Genzyme Roy Baranello, Wyeth Amit Sachdev, BIO Donna Peterson, Amgen Sara Radcliffe, BIO Bob Pietrusko, Millennium Andrew Emmett, BIO
3/30/06 Teleconference 3:00 to 4:00 PM 1 Hour	Status of subgroup activities and identification of issues for discussion at future Steering Group meetings. Plans for subsequent meetings of technical subgroups including meeting schedules and specific issues that will be discussed first in the subgroups and then the Steering Group.	FDA: Theresa Mullin, OPPL Jane Axelrad, CDER Ann Wion, OCC Robert Yetter, CBER John Jenkins, CDER Malcolm Bertoni, OPPL Martha Louviere, OM Fred Farmer, OCIO Deborah Henderson, CDER Nancy Boocker, CDER Ralph Lillie, CDER Roger McClung, HHS Patricia Stewart, OPPL PhRMA: Alan Goldhammer, PhRMA Tricia de Santis, Johnson and Johnson Lynne Tracey, Procter & Gamble Sharon Olmstead, Schering Plough Bill Rosen, Pfizer Peter Loupos, Sanofi-Aventis Bruce Burlington, Wyeth Gretchen Dieck, Pfizer Tony Rogers, AstraZeneca Don Sauer, Wyeth Scott Lassman, PhRMA Annetta Beauregard, Eli Lilly BIO: Alison Lawton, Genzyme Kay Holcombe, Genzyme Roy Baranello, Wyeth Amit Sachdev, BIO Donna Peterson, Amgen Sara Radcliffe, BIO Bob Pietrusko, Millennium Andrew Emmett, BIO
4/27/06 1:00 to 4:00 PM 3 Hours	FDA funding, costs and efficiencies Quality of application submissions FDA workload and productivity	FDA Theresa Mullin, OPPL Jane Axelrad, CDER John Jenkins, CDER Malcolm Bertoni, OPPL Frank Claunts, OM Fred Farmer, OCIO Deborah Henderson, CDER Nancy Boocker, CDER Ralph Lillie, CDER Roger McClung, HHS Karen Meister, OL Patricia Stewart, OPPL PhRMA: Alan Goldhammer, PhRMA Lynne Tracey, Procter & Gamble Bruce Burlington, Wyeth Tony Rogers, AstraZeneca Annetta Beauregard, Eli Lilly Tricia de Santis, Johnson and Johnson (tcon) BIO: Alison Lawton, Genzyme Kay Holcombe, Genzyme Roy Baranello, Wyeth Amit Sachdev, BIO Donna Peterson, Amgen Sara Radcliffe, BIO Bob Pietrusko, Millennium Andrew Emmett, BIO
5/11/06 2:30 to 4:00 PM 1 ½ Hours	Status of subgroup activities and the schedule for bringing issues to future Steering Group meetings	FDA: Theresa Mullin, OPPL John Jenkins, CDER Ann Wion, OCC Robert Yetter, CBER Frank Claunts, OM Malcolm Bertoni, OPPL Martha Louviere, OM Fred Farmer, OCIO Deborah Henderson, CDER Nancy Boocker, CDER Ralph Lillie, CDER Roger McClung, HHS Karen Meister, OL Howard Chazin, CDER Patricia Stewart, OPPL PhRMA: Alan Goldhammer, PhRMA Tricia de Santis, Johnson and Johnson Lynne Tracey, Procter & Gamble Sharon Olmstead, Schering Plough Bill Rosen, Pfizer Annetta Beauregard, Eli Lilly Bruce Burlington, Wyeth Gretchen Dieck, Pfizer Tony Rogers, AstraZeneca Don Sauer, Wyeth Scott Lassman, PhRMA BIO: Alison Lawton, Genzyme Kay Holcombe, Genzyme Roy Baranello, Wyeth Amit Sachdev, BIO Donna Peterson, Amgen Sara Radcliffe, BIO Bob Pietrusko, Millennium Andrew Emmett, BIO
5/25/06 1:00 to 3:00 PM 2 Hours	Areas of concern that were expressed by the Patient Advocacy and Consumer Groups at the May 22 and 23, 2006 PDUFA IV stakeholder meetings with FDA Finance subgroup technical proposals Premarket group technical proposals regarding meeting management process Status of subgroup activities and the schedule for bringing issues to future Steering Group meetings	FDA: Theresa Mullin, OPPL John Jenkins, CDER Ann Wion, OCC Robert Yetter, CBER Frank Claunts, OM Malcolm Bertoni, OPPL Martha Louviere, OM Fred Farmer, OCIO Deborah Henderson, CDER Nancy Boocker, CDER Ralph Lillie, CDER Michael Jones, CDER Karen Meister, OL Howard Chazin, CDER Patricia Stewart, OPPL PhRMA: Alan Goldhammer, PhRMA Tricia de Santis, Johnson and Johnson Lynne Tracey, Procter & Gamble Sharon Olmstead, Schering Plough Bill Rosen, Pfizer Annetta Beauregard, Eli Lilly Bruce Burlington, Wyeth Gretchen Dieck, Pfizer Tony Rogers, AstraZeneca Don Sauer, Wyeth Scott Lassman, PhRMA BIO: Alison Lawton, Genzyme Kay Holcombe, Genzyme Roy Baranello, Wyeth Amit Sachdev, BIO Donna Peterson, Amgen Sara Radcliffe, BIO Bob Pietrusko, Millennium Andrew Emmett, BIO
6/22/06 1:00 to 4:00 PM 3 Hours	Premarket subgroup proposals for meeting management goals CMA pilots The Inflation Adjustor proposal The model for the financial baseline for FY 2008 Status of subgroup activities and the schedule for bringing issues to future Steering Group meetings	FDA: Theresa Mullin, OPPL John Jenkins, CDER (tcon) Ann Wion, OCC Robert Yetter, CBER Frank Claunts, OM Malcolm Bertoni, OPPL Martha Louviere, OM Jane Axelrad, CDER Deborah Henderson, CDER Nancy Boocker, CDER Howard Chazin, CDER Roger McClung, HHS Patricia Stewart, OPPL PhRMA: Alan Goldhammer, PhRMA Tricia de Santis, Johnson and Johnson Lynne Tracey, Procter & Gamble Sharon Olmstead, Schering Plough Bill Rosen, Pfizer Tony Rogers, AstraZeneca Bruce Burlington, Wyeth Scott Lassman, PhRMA BIO: Alison Lawton, Genzyme Kay Holcombe, Genzyme Roy Baranello, Wyeth Amit Sachdev, BIO Donna Peterson, Amgen Sara Radcliffe, BIO Bob Pietrusko, Millennium Andrew Emmett, BIO
7/6/06Teleconference 1:00 to 2:30 PM 1 ½ Hours	Status of subgroup activities and the schedule for bringing issues to future Steering Group meetings Discussion of trends in appropriations for drug review	FDA: Theresa Mullin, OPPL Robert Yetter, CBER Ann Wion, OCC Malcolm Bertoni, OPPL Jane Axelrad, CDER Martha Louviere, OM Deborah Henderson, CDER Nancy Boocker, CDER Ralph Lillie, CDER Howard Chazin, CDER Roger McClung, HHS Patricia Stewart, OPPL PhRMA: Alan Goldhammer, PhRMA Tricia de Santis, Johnson and Johnson Bill Rosen, Pfizer Annetta Beauregard, Eli Lilly Bruce Burlington, Wyeth Gretchen Dieck, Pfizer Tony Rogers, AstraZeneca Don Sauer, Wyeth Scott Lassman, PhRMA Peter Loupos, Sanofi-Aventis BIO: Alison Lawton, Genzyme Kay Holcombe, Genzyme Roy Baranello, Wyeth Amit Sachdev, BIO Donna Peterson, Amgen Sara Radcliffe, BIO Bob Pietrusko, Millennium Andrew Emmett, BIO
7/13/06 Teleconference 1:00 to 2:00 PM 1 Hour	IT Communications and Technical Interactions proposal Status of subgroup activities and the schedule for bringing issues to future Steering Group meetings	FDA: Theresa Mullin, OPPL Robert Yetter, CBER Ann Wion, OCC Malcolm Bertoni, OPPL John Jenkins, CDER Frank Claunts, OM Deborah Henderson, CDER Martha Louviere, OM Ralph Lillie, CDER Nancy Boocker, CDER Karen Meister, OL Margo Burnette, OCIO Roger McClung, HHS Patricia Stewart, OPPL PhRMA: Alan Goldhammer, PhRMA Tricia de Santis, Johnson and Johnson Lynne Tracey, Procter & Gamble Sharon Olmstead, Schering Plough Bill Rosen, Pfizer Annetta Beauregard, Eli Lilly Bruce Burlington, Wyeth Gretchen Dieck, Pfizer Tony Rogers, AstraZeneca Peter Loupos, Sanofi-Aventis Scott Lassman, PhRMA BIO: Alison Lawton, Genzyme Kay Holcombe, Genzyme Roy Baranello, Wyeth Amit Sachdev, BIO Donna Peterson, Amgen Sara Radcliffe, BIO Andrew Emmett, BIO
7/20/06 Teleconference 1:00 to 2:00 PM 1 Hour	Status of subgroup activities and the schedule for bringing issues to future Steering Group meetings	FDA: Theresa Mullin, OPPL Jane Axelrad, CDER Ann Wion, OCC Malcolm Bertoni, OPPL Frank Claunts, OM Deborah Henderson, CDER Ralph Lillie, CDER Nancy Boocker, CDER Karen Meister, OL Patricia Stewart, OPPL Roger McClung, HHS PhRMA: Alan Goldhammer, PhRMA Scott Lassman, PhRMA Lynne Tracey, Procter & Gamble Sharon Olmstead, Schering Plough Bill Rosen, Pfizer Annetta Beauregard, Eli Lilly Bruce Burlington, Wyeth Peter Loupos, Sanofi-Aventis Tony Rogers, AstraZeneca BIO: Alison Lawton, Genzyme Kay Holcombe, Genzyme Roy Baranello, Wyeth Amit Sachdev, BIO Donna Peterson, Amgen Sara Radcliffe, BIO Bob Pietrusko, Millennium Andrew Emmett, BIO
7/27/06 1:00 to 4:00 PM 3 Hours	The inflation adjustor proposal The workload adjustor proposal Current status of CDER/CBER resources Trademark review process proposal Financial baseline and funding levels	FDA: Theresa Mullin, OPPL Ann Wion, OCC Malcolm Bertoni, OPPL Frank Claunts, OM John Jenkins, CDER Robert Yetter, CBER Deborah Henderson, CDER Jane Axelrad, CDER Ralph Lillie, CDER Nancy Boocker, CDER Karen Meister, OL Martha Louviere, OM Jonathan Mathieu, OPPL Roger McClung, HHS Patricia Stewart, OPPL PhRMA: Alan Goldhammer, PhRMA Scott Lassman, PhRMA Lynne Tracey, Procter & Gamble Sharon Olmstead, Schering Plough Bill Rosen, Pfizer Annetta Beauregard, Eli Lilly Bruce Burlington, Wyeth Peter Loupos, Sanofi-Aventis (tcon) Tony Rogers, AstraZeneca (tcon) Gretchen Dieck, Pfizer (tcon) Bob Lee, Eli Lilly (tcon) BIO: Alison Lawton, Genzyme Kay Holcombe, Genzyme Roy Baranello, Wyeth (tcon) Amit Sachdev, BIO Donna Peterson, Amgen Sara Radcliffe, BIO Bob Pietrusko, Millennium (tcon) Andrew Emmett, BIO
8/3/06 Teleconference 1:00 to 2:00 PM 1 Hour	Status of subgroup activities and the schedule for bringing issues to future Steering Group meetings	FDA: Theresa Mullin, OPPL Ann Wion, OCC Malcolm Bertoni, OPPL Frank Claunts, OM Robert Yetter, CBER Martha Louviere, OM Deborah Henderson, CDER Jane Axelrad, CDER Ralph Lillie, CDER Nancy Boocker, CDER Karen Meister, OL Roger McClung, HHS Howard Chazin, CDER Patricia Stewart, OPPL PhRMA: Alan Goldhammer, PhRMA Tricia de Santis, Johnson and Johnson Bill Rosen, Pfizer Annetta Beauregard, Eli Lilly Peter Loupos, Sanofi-Aventis Gretchen Dieck, Pfizer Tony Rogers, AstraZeneca BIO: Alison Lawton, Genzyme Kay Holcombe, Genzyme Roy Baranello, Wyeth Amit Sachdev, BIO Donna Peterson, Amgen Sara Radcliffe, BIO Andrew Emmett, BIO
8/10/06 Teleconference 1:00 to 2:00 PM 1 Hour	Status of subgroup activities and the schedule for bringing issues to future Steering Group meetings	FDA: Theresa Mullin, OPPL Ann Wion, OCC Malcolm Bertoni, OPPL Frank Claunts, OM John Jenkins, CDER Martha Louviere, OM Ralph Lillie, CDER Jane Axelrad, CDER Nancy Boocker, CDER Roger McClung, HHS Patricia Stewart, OPPL PhRMA: Alan Goldhammer, PhRMA Bruce Burlington, Wyeth Bill Rosen, Pfizer Annetta Beauregard, Eli Lilly Peter Loupos, Sanofi-Aventis Gretchen Dieck, Pfizer Tony Rogers, AstraZeneca Scott Lassman, PhRMA BIO: Alison Lawton, Genzyme Sara Radcliffe, BIO Donna Peterson, Amgen Andrew Emmett, BIO
8/24/06 Teleconference 1:00 to 2:00 PM 1 Hour	Status of subgroup activities and the schedule for bringing issues to future Steering Group meetings Next steps in FDA compliance with Public Accountability requirement for PDUFA reauthorization	FDA: Theresa Mullin, OPPL Ann Wion, OCC Malcolm Bertoni, OPPL Frank Claunts, OM John Jenkins, CDER Robert Yetter, CBER Ralph Lillie, CDER Jane Axelrad, CDER Nancy Boocker, CDER Roger McClung, HHS Karen Meister, OL Patricia Stewart, OPPL PhRMA: Alan Goldhammer, PhRMA Tricia de Santis, Johnson & Johnson Lynne Tracey, Proctor & Gamble Scott Lassman, PhRMA Peter Loupos, Sanofi-Aventis BIO: Bob Pietrusko, Millenium Amit Sachdev, BIO Roy Baranello, Wyeth Sara Radcliffe, BIO Kaye Holcolme, Genzyme Andrew Emmett, BIO
8/31/0Teleconference 1:00 to 2:00 PM 1 Hour	Status of subgroup activities and the schedule for bringing issues to future Steering Group meetings	FDA: Theresa Mullin, OPPL Frank Claunts, OM Malcolm Bertoni, OPPL Martha Louviere, OM Robert Yetter, CBER Deborah Henderson, CDER Ralph Lillie, CDER Jane Axelrad, CDER Nancy Boocker, CDER Roger McClung, HHS Karen Meister, OL Patricia Stewart, OPPL PhRMA: Alan Goldhammer, PhRMA Tricia de Santis, Johnson & Johnson Bruce Burlington, Wyeth Sharon Olmstead, Schering Plough Lynne Tracey, Proctor & Gamble Scott Lassman, PhRMA Peter Loupos, Sanofi-Aventis Bill Rosen, Pfizer Annette Beauregard, Eli Lilly BIO: Bob Pietrusko, Millenium Amit Sachdev, BIO Roy Baranello, Wyeth Sara Radcliffe, BIO Kaye Holcolme, Genzyme
9/7/06 1:00 to 5:00 PM 4 Hours	Discussion of proposed inflation adjustor and workload adjustor with a complexity factor Discussion of method for calculating the proposed PDUFA financial baseline in FY 2008. Discuss FDA proposal for 9 technical fixes	FDA: Theresa Mullin, OPPL Frank Claunts, OM Ann Wion, OCC Malcolm Bertoni, OPPL John Jenkins, CDER Robert Yetter, CBER Deborah Henderson, CDER Martha Louviere, OM Ralph Lillie, CDER Jane Axelrad, CDER Nancy Boocker, CDER Michael Jones, CDER (tcon) Karen Meister, OL Roger McClung, HHS Jonathan Mathieu, OPPL Patricia Stewart, OPPL PhRMA: Alan Goldhammer, PhRMA Tricia de Santis, Johnson & Johnson Bruce Burlington, Wyeth Sharon Olmstead, Schering Plough Scott Lassman, PhRMA Bill Rosen, Pfizer Peter Loupos, Sanofi-Aventis Tony Rogers, AztraZeneca Annette Beauregard, Eli Lilly Chin Koerner, Novartis Edward Tripp, Abbot Lynne Tracey, Proctor & Gamble (tcon) BIO: Bob Pietrusko, Millenium Amit Sachdev, BIO Roy Baranello, Wyeth Sara Radcliffe, BIO Kay Holcombe, Genzyme Andrew Emmett, BIO Alison Lawton, Genzyme Donna Peterson, Amgen
9/8/06 1:00 to 5:00 PM 4 Hours	Discussion of proposed inflation adjustor and workload adjustor with a complexity factor Discussion of method for calculating the proposed PDUFA financial baseline in FY 2008. Discuss safety program proposal Discuss electronic review environment proposal Discussion of proposal for timelines for labeling and post marketing commitment (PMC) discussions	FDA: Theresa Mullin, OPPL Frank Claunts, OM Ann Wion, OCC Malcolm Bertoni, OPPL John Jenkins, CDER Robert Yetter, CBER Deborah Henderson, CDER Martha Louviere, OM Ralph Lillie, CDER Jane Axelrad, CDER Nancy Boocker, CDER Michael Jones, CDER (tcon) Karen Meister, OL Roger McClung, HHS (tcon) Howard Chazin, CDER Patricia Stewart, OPPL PhRMA: Alan Goldhammer, PhRMA Tricia de Santis, Johnson & Johnson Bruce Burlington, Wyeth Sharon Olmstead, Schering Plough Scott Lassman, PhRMA Gretchen Dieck, Pfizer (tcon) Peter Loupos, Sanofi-Aventis Bill Rosen, Pfizer Annette Beauregard, Eli Lilly Tony Rogers, AztraZeneca Edward Tripp, Abbot Chin Koerner, Novartis Lynne Tracey, Proctor & Gamble (tcon) BIO: Bob Pietrusko, Millenium Amit Sachdev, BIO Roy Baranello, Wyeth Sara Radcliffe, BIO Kay Holcombe, Genzyme Andrew Emmett, BIO Donna Peterson, Amgen
9/21/06 1:00 to 3:30 PM 2 ½ Hours	Continued discussion of proposed enhancments for PDUFA IV Status of subgroup activities and the schedule for bringing issues to future Steering Group meetings	FDA: Theresa Mullin, OPPL Frank Claunts, OM Ann Wion, OCC Malcolm Bertoni, OPPL John Jenkins, CDER Robert Yetter, CBER Deborah Henderson, CDER Martha Louviere, OM Jane Axelrad, CDER Nancy Boocker, CDER Karen Meister, OL Michael Jones, CDER (tcon) Roger McClung, HHS (tcon) Patricia Stewart, OPPL PhRMA: Alan Goldhammer, PhRMA Bruce Burlington, Wyeth Gretchen Dieck, Pfizer (tcon) Bill Rosen, Pfizer Scott Lassman, PhRMA (tcon) Tony Rogers, AztraZeneca Peter Loupos, Sanofi-Aventis (tcon) Annette Beauregard, Eli Lilly (tcon) Tricia de Santis, Johnson & Johnson (tcon) Sharon Olmstead, Schering Plough (tcon) Lynne Tracey, Proctor & Gamble (tcon) BIO: Bob Pietrusko, Millenium Amit Sachdev, BIO Roy Baranello, Wyeth Sara Radcliffe, BIO Kay Holcombe, Genzyme Andrew Emmett, BIO Alison Lawton, Genzyme Donna Peterson, Amgen (tcon)
10/5/06 9:00 to 11:00 AM 2 Hours	Direct to consumer advertising review proposal Sound financial footing proposals Proposed resource requirements Implementation of Good review Management Principles (GRMPs) Proprietary name review	FDA: Theresa Mullin, OPPL Frank Claunts, OM Ann Wion, OCC Malcolm Bertoni, OPPL John Jenkins, CDER Robert Yetter, CBER Deborah Henderson, CDER Martha Louviere, OM Ralph Lillie, CDER Jane Axelrad, CDER Michael Jones, CDER (tcon) Roger McClung, HHS Patricia Stewart, OPPL PhRMA: Alan Goldhammer, PhRMA Bruce Burlington, Wyeth Scott Lassman, PhRMA Gretchen Dieck, Pfizer Bill Rosen, Pfizer Tony Rogers, AztraZeneca (tcon) Annette Beauregard, Eli Lilly Tricia de Santis, Johnson & Johnson (tcon) Sharon Olmstead, Schering Plough Lynne Tracey, Proctor & Gamble (tcon) BIO: Bob Pietrusko, Millenium Amit Sachdev, BIO Roy Baranello, Wyeth Sara Radcliffe, BIO Kay Holcombe, Genzyme Andrew Emmett, BIO Alison Lawton, Genzyme Donna Peterson, Amgen (tcon)
10/12/06 Teleconference 1:00 to 1:30 PM ½ Hour	Workload adjustor complexity factor Expedited drug development guidances GRMP implementation proposal Direct to consumer advertising (DTCA) proposal Discuss proposal to eliminate the legislative language that restricts using PDUFA funds to the peri-approval period of 2-3 years post approval	FDA: Theresa Mullin, OPPL Frank Claunts, OM Ann Wion, OCC Malcolm Bertoni, OPPL John Jenkins, CDER Robert Yetter, CBER Deborah Henderson, CDER Howard Chazin, CDER Ralph Lillie, CDER Jane Axelrad, CDER Michael Jones, CDER Nancy Boocker, CDER Karen Meister, OL Patricia Stewart, OPPL PhRMA: Alan Goldhammer, PhRMA Tricia de Santis, Johnson & Johnson Petr Loupos, Sanofi-Aventis Sharon Olmstead, Schering Plough Lynne Tracey, Proctor & Gamble Scott Lassman, PhRMA Bill Rosen, Pfizer Gretchen Dieck, Pfizer Annette Beauregard, Eli Lilly Tony Rogers, AztraZeneca BIO: Bob Pietrusko, Millenium Amit Sachdev, BIO Donna Peterson, Amgen Sara Radcliffe, BIO Kay Holcombe, Genzyme Andrew Emmett, BIO
11/2/06 1:00 to 4:00 PM 3 Hours	Discuss proposed changes to the commitment letter Discuss proposed changes to legislative language	FDA: Theresa Mullin, OPPL Frank Claunts, OM Ann Wion, OCC Martie Louviere, OM John Jenkins, CDER Mark Gray, OM Deborah Henderson, CDER Jane Axelrad, CDER Ralph Lillie, CDER Michael Jones, CDER Nancy Boocker, CDER Michael Sauers, HHS Ann Sullivan, OPPL Robert Yetter, CBER PhRMA: Alan Goldhammer, PhRMA Bruce Burlington, Wyeth Scott Lassman, PhRMA Gretchen Dieck, Pfizer Tony Rogers, AstraZeneca Annetta Beauregard, Eli Lilly Lynne Tracey, Procter & Gamble Tricia de Santis, Johnson and Johnson Peter Loupos, Sanofi-Aventis Bill Rosen, Pfizer BIO: Amit Sachdev, BIO Donna Peterson, Amgen Sara Radcliffe, BIO Kay Holcombe, Genzyme Andrew Emmett, BIO Alison Lawton, Genzyme Roy Baranello, Wyeth

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