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Date Time Length |
Subjects | Participants |
---|---|---|
03/29/06 2:00 p.m. 2 hours |
|
Malcolm Bertoni, FDA Fred Farmer, FDA Mark Gray, FDA Len Wilson, FDA Margo Burnette, FDA Peter Beckerman, FDA Rachel Carle, Genzyme Joe Quinn, sanofi pasteur (BIO) Andrew Emmett, BIO Bob Birmingham, Johnson & Johnson PRD Edward Tripp, Abbott Laboratories Peter Loupos, sanofi aventis Bill Rosen, Pfizer Alison Lawton, Genzyme Steve Ward, Lilly |
04/19/06 1:00 p.m. 2 hours |
|
Malcolm Bertoni, FDA Fred Farmer, FDA Mark Gray, FDA Len Wilson, FDA Margo Burnette, FDA Armando Oliva, FDA Allen Jones, GSK Joe Quinn, sanofi pasteur (BIO) Andrew Emmett, BIO Bob Birmingham, Johnson & Johnson PRD Bill Rosen, Pfizer Rachel Carle, Genzyme Peter Loupos, sanofi aventis Steve Ward, Lilly Edward Tripp, Abbott Laboratories |
05/03/06 1:00 p.m. 2 hours |
|
Malcolm Bertoni, FDA Fred Farmer, FDA Mark Gray, FDA Len Wilson, FDA Margo Burnette, FDA Peter Beckerman, FDA Peter Loupos, sanofi aventis Bill Rosen, Pfizer Andrew Emmett, BIO Joe Quinn, sanofi pasteur (BIO) Edward Tripp, Abbott Laboratories Alison Lawton, Genzyme Monica Mehta, Genzyme Steve Ward, Lilly Bob Birmingham, Johnson & Johnson PRD |
05/05/06 1:30 p.m. 90 minutes |
Discuss concept of shared information exchange | Malcolm Bertoni, FDA Fred Farmer, FDA Gary Gensinger, FDA Mark Gray, FDA Margo Burnette, FDA Peter Beckerman, FDA Ginger Leo, FDA Peter Loupos, sanofi aventis Bill Rosen, Pfizer Andrew Emmett, BIO Bob Birmingham, Johnson & Johnson PRD Edward Tripp, Abbott Laboratories Allen Jones, GSK Steve Ward, Lilly |
05/17/06 1:00 p.m. 2 hours |
FDA PDUFA IV cost estimate | Malcolm Bertoni, FDA Armando Oliva, FDA Mark Gray, FDA Len Wilson, FDA Margo Burnette, FDA Peter Loupos, sanofi aventis Bill Rosen, Pfizer Andrew Emmett, BIO Joe Quinn, sanofi pasteur (BIO) Edward Tripp, Abbott Laboratories Alan Goldhammer, PhRMA Steve Ward, Lilly Alison Lawton, Genzyme Rachel Carle, Genzyme Bob Birmingham, Johnson & Johnson PRD |
05/24/06 8:30 a.m. 1 hour |
Follow-up on FDA IT cost estimate | Malcolm Bertoni, FDA Mark Gray, FDA Margo Burnette, FDA Ginger Leo, FDA Tim Mahoney, FDA Andrew Emmett, BIO Joe Quinn, sanofi pasteur (BIO) Bob Birmingham, Johnson & Johnson PRD Steve Ward, Lilly Bill Rosen, Pfizer |
05/31/06 1:00 p.m. 2 hours |
|
Malcolm Bertoni, FDA Fred Farmer, FDA Mark Gray, FDA Len Wilson, FDA Armando Oliva, FDA Andrew Emmett, BIO Edward Tripp, Abbott Laboratories Len Wilson, FDA Joe Quinn, sanofi pasteur (BIO) Bob Birmingham, Johnson & Johnson PRD Rachel Carle, Genzyme Peter Loupos, sanofi Aventis Steve Ward, Lilly Bill Rosen, Pfizer |
06/14/06 1:00 p.m. 2 hours |
|
Malcolm Bertoni, FDA Fred Farmer, FDA Mark Gray, FDA Len Wilson, FDA Armando Oliva, FDA Margo Burnette, FDA Bill Rosen, Pfizer Andrew Emmett, BIO Edward Tripp, Abbott Laboratories Joe Quinn, sanofi pasteur (BIO) Bob Birmingham, Johnson & Johnson PRD Rachel Carle, Genzyme Peter Loupos, sanofi Aventis Steve Ward, Lilly Alan Goldhammer, PhRMA Alison Lawton, Genzyme |
06/28/06 9:00 a.m. 2 hours |
|
Malcolm Bertoni, FDA Len Wilson, FDA Mark Gray, FDA Armando Oliva, FDA Margo Burnette, FDA Edward Tripp, Abbott Laboratories Andrew Emmett, BIO Steve Ward, Lilly Bob Birmingham, Johnson & Johnson PRD Rachel Carle, Genzyme |
06/28/06 1:00 p.m. 2 hours |
|
Malcolm Bertoni, FDA Fred Farmer, FDA Len Wilson, FDA Mark Gray, FDA Armando Oliva, FDA Margo Burnette, FDA Edward Tripp, Abbott Laboratories Andrew Emmett, BIO Steve Ward, Lilly Bob Birmingham, Johnson & Johnson PRD Rachel Carle, Genzyme Bill Rosen, Pfizer Alan Goldhammer, PhRMA |
07/12/06 9:00 a.m. 2 hours |
|
Malcolm Bertoni, FDA Len Wilson, FDA Mark Gray, FDA Armando Oliva, FDA Margo Burnette, FDA Peter Loupos, sanofi aventis Andrew Emmett, BIO Bill Rosen, Pfizer Rachel Carle, Genzyme Allen Jones, GSK Joe Quinn, sanofi pasteur (BIO) Edward Tripp, Abbott Laboratories Bob Birmingham, Johnson & Johnson PRD |
07/12/06 1:00 p.m. 2 hours |
|
Malcolm Bertoni, FDA Len Wilson, FDA Mark Gray, FDA Armando Oliva, FDA Margo Burnette, FDA Peter Loupos, sanofi aventis Andrew Emmett, BIO Bill Rosen, Pfizer Rachel Carle, Genzyme Allen Jones, GSK Joe Quinn, sanofi pasteur (BIO) Edward Tripp, Abbott Laboratories Bob Birmingham, Johnson & Johnson PRD |
07/19/06 1:30 p.m. 2 hours |
|
Malcolm Bertoni, FDA Len Wilson, FDA Mark Gray, FDA Armando Oliva, FDA Margo Burnette, FDA Peter Loupos, sanofi aventis Andrew Emmett, BIO Bill Rosen, Pfizer Rachel Carle, Genzyme Allen Jones, GSK Bob Birmingham, Johnson & Johnson PRD |
07/26/06 9:00 a.m. 2 hours |
|
Malcolm Bertoni, FDA Len Wilson, FDA Mark Gray, FDA Armando Oliva, FDA Margo Burnette, FDA Bill Rosen, Pfizer Andrew Emmett, BIO Steve Ward, Lilly Rachel Carle, Genzyme Bob Birmingham, Johnson & Johnson PRD Joe Quinn, sanofi pasteur (BIO) Alan Goldhammer, PhRMA |
07/26/06 1:00 p.m. 2 hours |
|
Malcolm Bertoni, FDA Len Wilson, FDA Mark Gray, FDA Armando Oliva, FDA Margo Burnette, FDA Bill Rosen, Pfizer Andrew Emmett, BIO Steve Ward, Lilly Rachel Carle, Genzyme Bob Birmingham, Johnson & Johnson PRD Joe Quinn, sanofi pasteur (BIO) Alan Goldhammer, PhRMA Peter Loupos, sanofi Aventis Allen Jones, GSK |
08/02/06 9:00 a.m. 2 hours |
Review Industry Goals and Objectives in relation to the Commitment Letter | Malcolm Bertoni, FDA Len Wilson, FDA Mark Gray, FDA Margo Burnette, FDA Armando Oliva, FDA Bill Rosen, Pfizer Andrew Emmett, BIO Steve Ward, Lilly Rachel Carle, Genzyme Bob Birmingham, Johnson & Johnson PRD Joe Quinn, sanofi pasteur (BIO) Alan Goldhammer, PhRMA Edward Tripp, Abbott Laboratories |
08/09/06 9:00 a.m. 2 hours |
|
Malcolm Bertoni, FDA Len Wilson, FDA Mark Gray, FDA Armando Oliva, FDA Margo Burnette, FDA Bill Rosen, Pfizer Andrew Emmett, BIO Joe Quinn, sanofi pasteur (BIO) Edward Tripp, Abbott Laboratories Alan Goldhammer, PhRMA Allen Jones, GSK Steve Ward, Lilly Rachel Carle, Genzyme |
08/09/06 1:00 p.m 2 hours |
|
Malcolm Bertoni, FDA Len Wilson, FDA Mark Gray, FDA Armando Oliva, FDA Margo Burnette, FDA Bill Rosen, Pfizer Andrew Emmett, BIO Joe Quinn, sanofi pasteur (BIO) Edward Tripp, Abbott Laboratories Alan Goldhammer, PhRMA Allen Jones, GSK Steve Ward, Lilly Rachel Carle, Genzyme |
08/16/06 9:00 a.m. 2 hours |
|
Malcolm Bertoni, FDA Len Wilson, FDA Mark Gray, FDA Armando Oliva, FDA Margo Burnette, FDA Bill Rosen, Pfizer Andrew Emmett, BIO Joe Quinn, sanofi pasteur (BIO) Rachel Carle, Genzyme Steve Ward, Lilly Bob Birmingham, Johnson & Johnson PRD Allen Jones, GSK |
08/16/06 1:00 p.m. 2 hours |
|
Malcolm Bertoni, FDA Len Wilson, FDA Mark Gray, FDA Armando Oliva, FDA Margo Burnette, FDA Bill Rosen, Pfizer Andrew Emmett, BIO Joe Quinn, sanofi pasteur (BIO) Rachel Carle, Genzyme Steve Ward, Lilly Bob Birmingham, Johnson & Johnson PRD Allen Jones, GSK Peter Loupos, sanofi aventis |
08/30/06 9:00 a.m. 2 hours |
Review of the IT/IM commitment letter language | Malcolm Bertoni, FDA Len Wilson, FDA Mark Gray, FDA Armando Oliva, FDA Margo Burnette, FDA Peter Beckerman, FDA Bill Rosen, Pfizer Peter Loupos, sanofi aventis Steve Ward, Lilly Rachel Carle, Genzyme Bob Birmingham, Johnson & Johnson PRD Joe Quinn, sanofi pasteur (BIO) Alan Goldhammer, PhRMA Edward Tripp, Abbott Laboratories Allen Jones, GSK |
09/06/06 11:00 a.m. 1 hour |
Review presentation to the PDUFA Steering Committee | Malcolm Bertoni, FDA Len Wilson, FDA Mark Gray, FDA Margo Burnette, FDA Bill Rosen, Pfizer Steve Ward, Lilly Rachel Carle, Genzyme Bob Birmingham, Johnson & Johnson PRD Joe Quinn, sanofi pasteur (BIO) Edward Tripp, Abbott Laboratories Andrew Emmett, BIO Allen Jones, GSK |
09/07/06 11:30 a.m 1 hour. |
Review presentation to the PDUFA Steering Committee | Malcolm Bertoni, FDA Len Wilson, FDA Mark Gray, FDA Margo Burnette, FDA Peter Loupos, sanofi aventis Bill Rosen, Pfizer Rachel Carle, Genzyme Edward Tripp, Abbott Laboratories |
09/15/06 10:00 a.m. 1 hour |
Review commitment letter language | Malcolm Bertoni, FDA Len Wilson, FDA Mark Gray, FDA Armando Oliva, FDA Margo Burnette, FDA Peter Loupos, sanofi aventis Bill Rosen, Pfizer Rachel Carle, Genzyme Edward Tripp, Abbott Laboratories |
12/06/06 3:00 p.m 30 minutes |
PDUFA IV proposal update/status | Malcolm Bertoni, FDA Mark Gray, FDA Margo Burnette, FDA Bill Rosen, Pfizer Steve Ward, Lilly Rachel Carle, Genzyme Joe Quinn, sanofi pasteur (BIO) Alan Goldhammer, PhRMA Edward Tripp, Abbott Laboratories Andrew Emmett, BIO Allen Jones, GSK |