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Table 3. PDUFA IV Meetings – Technical Discussions with Regulated Industry Pre-Market Review Subgroup

Date Time Length	Subjects	Participants
3/24/06 10:00-12:00 pm 2 hours	Administrative matters regarding meeting times, dates and location Ground rules for group conduct Presentation of FDA issues surrounding PDUFA pre-market review Presentation of industry issues surrounding PDUFA pre-market review	FDA: John Jenkins, CDER; Robert Yetter, CBER Kim Colangelo, CDER; Kevin Fain, OCC Christopher Joneckis, CBER Michael Lanthier, CDER PhRMA: Bruce Burlington, Wyeth; Alan Goldhammer, PhRMA Sharon Olmstead, Schering Plough BIO: Roy Baranello, Wyeth; Andrew Emmett, BIO Kay Holcombe, Genzyme; Sara Radcliffe, BIO
04/07/06 10:00-12:00 pm 2 Hours	Discuss proposal regarding postmarketing study commitments Discuss possible performance goals for resubmissions to prior approval manufacturing supplements Discuss meeting management proposals FDA response to industry data requests	FDA: John Jenkins, CDER; Robert Yetter, CBER Kim Colangelo, CDER; Michael Lanthier, CDER Armando Oliva, CDER PhRMA: Alan Goldhammer, PhRMA Sharon Olmstead, Schering Plough BIO: Roy Baranello, Wyeth; Doug Dobak, AstraZeneca Andrew Emmett, BIO; Kay Holcombe, Genzyme Sara Radcliffe, BIO
04/21/06 10:00-12:00 pm 2 Hours	Proposal regarding labeling discussions Discuss meeting management proposals FDA response to data requests for commercial INDs submitted, clinical holds of commercial INDs, and clinical special protocol assessments submitted Discuss Postmarketing Study Commitment proposals	FDA: John Jenkins, CDER; Robert Yetter, CBER Kim Colangelo, CDER; Chris Joneckis, CBER Michael Lanthier, CDER ; Robert Meyer, CDER Lynn Whipkey Mehler, FDA (via telephone) PhRMA: Bruce Burlington, Wyeth; Alan Goldhammer, PhRMA Greg Brophy, Lilly (via telephone) Sharon Olmstead, Schering Plough BIO: Roy Baranello, Wyeth; Doug Dobak, AstraZeneca Kay Holcombe, Genzyme; Sara Radcliffe, BIO
05/05/06 10:00-12:00 pm 2 Hours	Discuss proposal on Prior Approval Manufacturing Supplement resubmission performance goals Discussion of current performance goals that adversely impact FDA productivity and efficiency Discussion of ways to improve application quality Discussion of alternative methods to achieve goals regarding Postmarketing study commitments and labeling Timeline for Steering committee presentations	FDA: John Jenkins, CDER; Robert Yetter, CBER Kim Colangelo, CDER; Chris Joneckis, CBER Robert Meyer, CDER; David Morley, CDER PhRMA: Bruce Burlington, Wyeth; Alan Goldhammer, PhRMA Greg Brophy, Lilly (via telephone) Sharon Olmstead, Schering Plough BIO: Roy Baranello, Wyeth; Andrew Emmett, BIO Doug Dobak, AstraZeneca ; Kay Holcombe, Genzyme Sara Radcliffe, BIO
05/19/06 10:00-12:00 pm 2 Hours	Discussion of critical path Discussion of Continuous Marketing Application (CMA) Pilots 1 and 2 Discussion of Prior Approval Manufacturing Supplement resubmission performance goals Discussion of proposal to eliminate the goal regarding independent consultants at meetings to discuss biotechnology clinical trial protocols Discuss inclusion of additional information in meeting requests Continued group discussion of ways to improve application quality	FDA: John Jenkins, CDER; Robert Yetter, CBER Kim Colangelo, CDER; Chris Joneckis, CBER Michael Lanthier, CDER; Robert Meyer, CDER Rachel Behrman, FDA; Howard Chazin, CDER/FDA PhRMA: Bruce Burlington, Wyeth (via telephone) Alan Goldhammer, PhRMA Sharon Olmstead, Schering Plough Greg Brophy, Lilly BIO Roy Baranello, Wyeth; Doug Dobak, AstraZeneca Andrew Emmett, BIO (via telephone) Kay Holcombe, Genzyme Sara Radcliffe, BIO
06/02/06 9:00-12:00 pm 3 Hours	FDA presentation of special study on time/level of effort requirements to respond to meetings and special protocol assessment requests FDA presentation of modified workload adjuster proposal Discussion of proposal to discontinue CMA Pilots Discuss inclusion of additional information in meeting requests	FDA: John Jenkins, CDER; Robert Yetter, CBER Kim Colangelo, CDER; Michael Lanthier, CDER Lynn Whipkey Mehler, FDA (via telephone) Robert Meyer, CDER Howard Chazin, CDER/FDA Jonathan Mathieu, FDA PhRMA: Bruce Burlington, Wyeth; Alan Goldhammer, PhRMA Sharon Olmstead, Schering Plough Greg Brophy, Lilly BIO: Roy Baranello, Wyeth; Andrew Emmett, BIO Doug Dobak, AstraZeneca; Kay Holcombe, Genzyme Sara Radcliffe, BIO
06/16/06 10:00-12:00 pm 2 Hours	Discussion of critical path to drug development Discussion of proposal to discontinue CMA Pilots Continued discussion of proposals intended to improve application quality	FDA: John Jenkins, CDER; Robert Yetter, CBER Kim Colangelo, CDER; Chris Joneckis (via telephone) Michael Lanthier, CDER; Robert Meyer, CDER Lynn Whipkey Mehler, FDA (via telephone) Rachel Behrman, FDA Theresa Mullin, FDA (via telephone) Howard Chazin, CDER/FDA; PhRMA: Bruce Burlington, Wyeth; Alan Goldhammer, PhRMA Greg Brophy, Lilly; Sharon Olmstead, Schering Plough BIO: Andrew Emmett, BIO (via telephone) Doug Dobak, AstraZeneca Kay Holcombe, Genzyme; Sara Radcliffe, BIO
06/30/06 9:00-12:00pm 3 Hours	Discussion of workload adjuster proposal Continued discussion of proposals intended to improve application quality Discussion of savings from the elimination of CMA pilot programs	FDA: John Jenkins, CDER; Chris Joneckis, CBER Kim Colangelo, CDER ; Michael Lanthier, CDER Robert Yetter, CBER (via telephone) Jonathan Mathieu, FDA Lynn Whipkey Mehler, FDA (via telephone) Howard Chazin, CDER/FDA Robert Meyer, CDER; PhRMA: Bruce Burlington, Wyeth; Alan Goldhammer, PhRMA Jeff Jeffress, Boston Consulting Group Greg Brophy, Lilly BIO: Andrew Emmett, BIO; Roy Baranello, Wyeth Doug Dobak, AstraZeneca; Kay Holcombe, Genzyme Sara Radcliffe, BIO
7/14/06 9:00-12:00 pm 3 Hours	Discussion of FDA meeting and SPA workload Discussion of the modified workload adjuster proposal	FDA: John Jenkins, CDER; Robert Yetter, CBER Kim Colangelo, CDER (via telephone) Chris Joneckis, CBER Michael Lanthier, CDER; Howard Chazin, CDER/FDA Lynn Whipkey Mehler, FDA (via telephone) Jonathan Mathieu, FDA Robert Meyer, CDER; Theresa Mullin, FDA Beth Duvall-Miller, CDER; PhRMA: Bruce Burlington, Wyeth; Alan Goldhammer, PhRMA Greg Brophy, Lilly; Martha Brumfield, Pfizer Sharon Olmstead, Schering Plough Jeff Jeffress, Boston Consulting Group (via telephone) BIO: Andrew Emmett, BIO; Roy Baranello, Wyeth Doug Dobak, AstraZeneca; Kay Holcombe, Genzyme Sara Radcliffe, BIO
7/28/06 9:00-12:00 pm 3 Hours	Discussion of proposed projects to expedite drug development	FDA: John Jenkins, CDER; Robert Yetter, CBER Kim Colangelo, CDER; Chris Joneckis, CBER Lynn Whipkey Mehler, FDA (via telephone) Robert Meyer, CDER; Nancy Derr, FDA; Shirley Murphy, CDER Robert Temple, CDER; Janet Woodcock, FDA Elizabeth Kamp, FDA (student volunteer) PhRMA: Bruce Burlington, Wyeth; Alan Goldhammer, PhRMA Greg Brophy, Lilly; Sharon Olmstead, Schering Plough Jeff Jeffress, Boston Consulting Group BIO: Andrew Emmett, BIO; Roy Baranello, Wyeth Doug Dobak, AstraZeneca; Kay Holcombe, Genzyme Sara Radcliffe, BIO (via telephone)
8/11/06 9:00-12:00 pm 3 Hours	Further discussion of proposed projects to expedite drug development Discussion of GRMP review timelines Discussion of a path forward for modified workload adjuster proposal Plans for achieving wrap-up of subgroup discussions by mid-September	FDA: John Jenkins, CDER; Kim Colangelo, CDER; Chris Joneckis, CBER Lynn Whipkey Mehler, FDA (via telephone) Howard Chazin, CDER/FDA Shiew Mei Huang, CDER (via telephone) Shirley Murphy, CDER Robert O'Neill, CDER PhRMA: Bruce Burlington, Wyeth; Alan Goldhammer, PhRMA Greg Brophy, Lilly; Martha Brumfield, Pfizer Derrick Fu, PhRMA (via telephone) BIO Roy Baranello, Wyeth; Doug Dobak, AstraZeneca Kay Holcombe, Genzyme (via telephone) Sara Radcliffe, BIO
8/18/06 9:00-11:00am 2 Hours	Discussion of proposed language for goals letter regarding meeting management goals Discussion of FDA proposal regarding GRMP review timelines	FDA: John Jenkins, CDER; Robert Yetter, CBER Kim Colangelo, CDER; Mike Lanthier, CDER PhRMA: Alan Goldhammer, PhRMA; Martha Brumfield, Pfizer Sharon Olmstead, Schering Plough BIO: Andrew Emmett, BIO; Roy Baranello, Wyeth Doug Dobak, AstraZeneca; Sara Radcliffe, BIO Kay Holcombe, Genzyme (via telephone)
8/25/06 9:00-12:00 pm 3 Hours	Discussion of proposed projects to expedite drug development Review of proposed goals letter language, including overall revisions for PDUFA first-cycle initiative and added section on notification of planned review timelines	FDA: John Jenkins, CDER; Robert Yetter, CBER Kim Colangelo, CDER; Mike Lanthier, CDER Lynn Whipkey Mehler, FDA (via telephone) Robert Meyer, CDER Howard Chazin, CDER/FDA Kathryn Carbone, CBER Shirley Murphy, CDER; Robert Temple, CDER Robert O'Neill, CDER (via telephone) PhRMA: Alan Goldhammer, PhRMA; Greg Brophy, Lilly Martha Brumfield, Pfizer; Sharon Olmstead, Schering Plough (via telephone) BIO: Andrew Emmett, BIO; Roy Baranello, Wyeth Doug Dobak, AstraZeneca ; Sara Radcliffe, BIO Kay Holcombe, Genzyme (via telephone)
9/1/06 9:00-11:00 am 2 Hours	Discussion of Expediting Drug Development Projects proposal Discusion of proposed goals letter language	FDA: Robert Yetter, CBER; Howard Chazin, CDER Lynn Whipkey Mehler, FDA (via telephone) Beth Duvall-Miller, CDER PhRMA: Greg Brophy, Lilly (via telephone) Alan Goldhammer, PhRMA Sharon Olmstead, Schering Plough Bruce Burlington, Wyeth (via telephone) BIO: Sara Radcliffe, BIO (via telephone) Roy Baranello, Wyeth Doug Dobak, AstraZeneca (via telephone) Kay Holcombe, Genzyme (via telephone)
9/8/06 9:00-12:00 pm 3 Hours	Discussion of proposals regarding "Expediting Projects" Review of proposed goals letter language on the notification of planned review timelines	FDA: John Jenkins, CDER; Robert Yetter, CBER Kim Colangelo, CDER; Mike Lanthier, CDER Robert Meyer, CDER (via telephone) PhRMA: Alan Goldhammer, PhRMA; Greg Brophy, Lilly Martha Brumfield, Pfizer; Sharon Olmstead, Schering Plough (via telephone) BIO: Andrew Emmett, BIO; Roy Baranello, Wyeth Doug Dobak, AstraZeneca (via telephone) Kay Holcombe, Genzyme

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