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| Date Time Length |
Subjects | Participants |
|---|---|---|
| March 29, 2006 10:00 a.m. – Noon 2 hours |
Agree to issues that the subgroup will consider and some initial timelines for deliverables | FDA: Debbie.Henderson, CDER Miles Braun, CBER Ralph Lillie, CDER Heidi Gertner, OCC Julie Beitz, CDER Anne Henig, CDER PhRMA: Alan Goldhammer, PhRMA Jim Kotsanos, Eli Lilly Scott Lassman, PhRMA Gretchen Dieck, Pfizer Dave Pizzuti, Johnson & Johnson Bob Lee, Eli Lilly Ron Garutti, Schering Plough BIO: Andrew Emmett, BIO Kay Holcombe, Genzyme Sara Radcliffe, BIO Bob Pietrusko, Millennium Phil Noguchi, Amgen |
| April 6, 2006 10:00 a.m. – Noon 2 hours |
Presentation of FDA's proposal on how to enhance PDUFA-funded surveillance capacity. | FDA: Debbie.Henderson, CDER Miles Braun, CBER Ralph Lillie, CDER Judy Staffa, CDER Julie Beitz, CDER Cindy Kortepeter, CDER Anne Henig, CDER Heidi Gertner, OCC PhRMA: Alan Goldhammer, PhRMA Jim Kotsanos, Eli Lilly Scott Lassman, PhRMA Gretchen Dieck, Pfizer Dave Pizzuti, Johnson & Johnson BIO: Andrew Emmett, BIO Joanna Haas, Genzyme Sara Radcliffe, BIO Kay Holcombe, Genzyme Bob Pietrusko, Millennium Phil Noguchi, Amgen |
| April 20, 2006 10:00 a.m. – Noon 2 hours |
Presentation of FDA's proposals: Epidemiology Methods and Best Practices and Risk Minimization Plans | FDA: Debbie.Henderson, CDER Miles Braun, CBER Ralph Lillie, CDER Judy Staffa, CDER Julie Beitz, CDER Claudia Karwoski, CDER Carol Holquist, CDER Anne Henig, CDER Heidi Gertner OCC PhRMA: Alan Goldhammer, PhRMA Jim Kotsanos, Eli Lilly Scott Lassman, PhRMA Gretchen Dieck, Pfizer BIO: Andrew Emmett, BIO Kay Holcombe, Genzyme Sara Radcliffe, BIO Bob Pietrusko, Millennium |
| May 4, 2006 10:00 a.m. – 1:00 p.m. 3 hours |
Trademark Proposals | FDA: Debbie Henderson, CDER Judy Staffa, CDER Ralph Lillie, CDER Denise Toyer, CDER Julie Beitz, CDER Maryann Gallagher, CBER Carol Holquist, CDER Jane Axelrad, CDER Anne Henig, CDER PhRMA: Steve Hartman, Novartis Bob Lee, Lilly Doug Doban, Astra-Zeneca Scott Lassman, PhRMA Kathy Gans-Brangs, Astra-Zeneca BIO: Andrew Emmett, BIO Kay Holcombe, Genzyme Sara Radcliffe, BIO Bob Pietrusko, Millennium |
| May 18, 2006 10:00 a.m. – Noon 2 hours |
Resources needed for post marketing surveillance | FDA: Debbie Henderson, CDER Julie Beitz, CDER Ralph Lillie, CDER Judy Staffa, CDER Bob Ball, CBER Carol Holquist, CDER Heidi Gertner, OCC Anne Henig, CDER David Horowitz PhRMA: Alan Goldhammer, PhRMA Gretchen Dieck, Pfizer Dave Pizzuti, Johnson & Johnson BIO: Andrew Emmett, BIO Sara Radcliffe, BIO |
| June 1, 2006 10:00 a.m. – Noon 2 hours |
Follow up to resource discussion. OSE presentation on vision for postmarket surveillance and epidemiology | FDA: Debbie Henderson, CDER Anne Henig, CDER Ralph Lillie, CDER Gerald DalPan, CDER Bob Ball, CBER Judy Staffa, CDER PhRMA: Alan Goldhammer, PhRMA Jim Kotsanos, Lilly Scott Lassman, PhRMA Linda Carter, Johnson and Johnson Gretchen Dieck, Pfizer BIO: Andrew Emmett, BIO Bob Pietrusko, Millenium Sara Radcliffe, BIO Kay Holcombe, Genzyme |
| June 19, 2006 T-con between FDA and Industry 1:30 – 2:30 p.m. 1 hour |
Steps needed to move forward | FDA: Debbie Henderson, CDER Ralph Lillie, CDER PhRMA: Alan Goldhammer, PhRMA Jim Kotsanos, Lilly Scott Lassman, PhRMA Gretchen Dieck, Pfizer BIO: Bob Pietrusko, Millenium |
| June 29, 2006 10:00 a.m. – 1:00 p.m. 3 hours |
Tradename Discussion | FDA: Debbie Henderson, CDER Carol Holquist, CDER Ralph Lillie, CDER Anne Henig, CDER PhRMA: Bob Lee, Lilly Kathy Gans-Brangs, Astra-Zeneca Steve Hartman, Novartis Scott Lassman, PhRMA BIO: Kay Holcombe, Genzyme Bob Pietrusko, Millenium |
| July 5, 2006 T-con between FDA and Industry 8:00 – 9:00 a.m. 1 hour |
Finalize Tradename Proposal | FDA: Debbie Henderson, CDER Judy Staffa, CDER Ralph Lillie, CDER Heidi Gertner, OCC Carol Holquist, CDER Anne Henig, CDER Bob Sausville, CBER PhRMA: Alan Goldhammer, PhRMA Kathy Gans-Brangs, Astra-Zeneca Scott Lassman, PhRMA Steve Hartman, Novartis Gretchen Dieck, Pfizer Bob Lee, Lilly Jim Kotsanos, Lilly BIO: Bob Pietrusko, Millenium Kay Holcombe, Genzyme Andrew Emmett, BIO Sara Radcliffe, BIO |
| July 6, 2006 9:00 – 11:00 a.m. 2 hours |
Tradename Proposal | FDA: Debbie Henderson, CDER Judy Staffa, CDER Ralph Lillie, CDER Heidi Gertner, OCC Anne Henig, CDER PhRMA: Alan Goldhammer, PhRMA Gretchen Dieck, Pfizer Scott Lassman, PhRMA Jim Kotsanos, Lilly BIO: Bob Pietrusko, Millenium Kay Holcombe, Genzyme Andrew Emmett, BIO Sara Radcliffe, BIO |
| July 11, 2006 T-con between FDA and Industry 8:00 – 9:00 a.m. |
Further discussion on Trademark Proposal | FDA: Debbie.Henderson, CDER Ralph Lillie, CDER Heidi Gertner, OCC Anne Henig, CDER Carol Holquist, CDER Julie Beitz, CDER Maryann Gallagher, CBER Bob Sausville, CBER PhRMA: Alan Goldhammer, PhRMA Bob Lee, Lilly Steve Hartman, Novartis Kathy Gans-Brangs, Astra-Zeneca BIO: Bob Pietrusko, Millenium Kay Holcombe, Genzyme Sra Radcliffe, BIO |
| July 24, 2006 T-con between FDA and Industry 11:00 a.m. – Noon 1 hour |
Status of PDUFA document development | FDA: Debbie Henderson, CDER Anne Henig, CDER Ralph Lillie, CDER PhRMA: Alan Goldhammer, PhRMA Jim Kotsanos, Lilly Gretchen Dieck, Pfizer BIO: Bob Pietrusko, Millenium |
| July 25, 2006 T-con between FDA and Industry 8:00 – 9:00 a.m. 1 hour |
PDUFA Trademark Discussion | FDA: Debbie Henderson, CDER Carol Holquist, CDER Ralph Lillie, CDER Anne Henig, CDER Denise Toyer, CDER Ele Pratt, CBER Maryann Gallagher, CBER Julie Beitz, CDER Heidi Gertner, OCC PhRMA: Alan Goldhammer, PhRMA Scott Lassman, PhRMA Bob Lee, Lilly Kathy Gans-Brangs, Astra-Zeneca BIO: Kay Holcombe, Genzyme Bob Pietrusko, Millenium |
| July 27, 2006 9:30 – 11:30 a.m. 2 hours |
Trademark Review Proposal | FDA: Debbie Henderson, CDER Ralph Lillie, CDER Anne Henig, CDER Mary Willy, CDER Heidi Gertner, OCC PhRMA: Alan Goldhammer, PhRMA Gretchen Dieck, Pfizer Jim Kotsanos, Lilly BIO: Kay Holcombe, Genzyme Andrew Emmett, BIO Sara Radcliffe, BIO |
| August 3, 2006 10:00 a.m. – Noon 2 hours |
Review of draft proposal | FDA: Debbie Henderson, CDER Anne Henig, CDER Ralph Lillie, CDER Heidi Gertner, OCC PhRMA: Jim Kotsanos, Lilly Scott Lassman, PhRMA, Alan Goldhammer, PhRMA Gretchen Dieck, Pfizer BIO: Andrew Emmett, BIO Kay Holcombe, Genzyme Sara Radcliffe, BIO |
| August 24, 2006 10:00 a.m. – Noon 2 hours |
Discussion of the Enhancement and Modernization of the FDA Drug Safety System document | FDA: Debbie Henderson, CDER Anne Henig, CDER Ralph Lillie, CDER Judy Staffa, CDER Julie Beitz, CDER Heidi Gertner, OCC Cindy Kortepeter, CDER Bob Ball, CBER Min Chen, CDER PhRMA: Alan Goldhammer, PhRMA Jim Kotsanos, Lilly Scott Lassman, PhRMA, Gretchen Dieck, Pfizer BIO: Andrew Emmett, BIO Sara Radcliffe, BIO Kay Holcombe, Genzyme Bob Pietrusko, Millenium |
| August 31, 2006 10:00 a.m. – Noon 2 hours |
Discussion of the Enhancement and Modernization of the FDA Drug Safety System document | FDA: Debbie Henderson, CDER Anne Henig, CDER Ralph Lillie, CDER Judy Staffa, CDER Julie Beitz, CDER Miles Braun CBER PhRMA: Alan Goldhammer, PhRMA Jim Kotsanos, Lilly Scott Lassman, PhRMA BIO: Bob Pietrusko, Millenium Sara Radcliffe, BIO Kay Holcombe, Genzyme |
| September 7, 2006 T-con between FDA and Industry 9:00 – 10:00 a.m. 1 hour |
Discussion of the Enhancement and Modernization of the FDA Drug Safety System document | FDA: Debbie Henderson, CDER Anne Henig, CDER Ralph Lillie, CDER Judy Staffa, CDER Julie Beitz, CDER Miles Braun, CBER PhRMA: Alan Goldhammer, PhRMA Gretchen Dieck, Pfizer Scott Lassman, PhRMA BIO: Bob Pietrusko, Millenium Andrew Emmett, BIO Sara Radcliffe, BIO Kay Holcombe, Genzyme |
| October 12, 2006 T-con between FDA and Industry 9:00 – 11:00 p.m. 2 hours |
Discuss current goals letter and interface with IOM report | FDA: Debbie Henderson, CDER Anne Henig, CDER Ralph Lillie, CDER Judy Staffa, CDER Julie Beitz, CDER Heidi Gertner, OCC PhRMA: Alan Goldhammer, PhRMA Gretchen Dieck, Pfizer Scott Lassman, PhRMA Jim Kotsanos, Lilly BIO: Bob Pietrusko, Millenium Andrew Emmett, BIO Sara Radcliffe, BIO |