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FDA Hearing December 17, 2012 - FDA Panel
Grail Sipes - Senior Regulatory Counsel, Office of Regulatory Policy, FDA Center for Drug Evaluation and Research
Sandra Queer - Deputy Director, Office of New Drugs, FDA Center for Drug Evaluation and Research
Chistine Wing - Acting Deputy Director, Office of Drug Evaluation, FDA Center for Drug Evaluation and Research
Bob Rappaport - Director, Division of Anesthesia, Analgesia and Addiction Products, FDA Center for Drug Evaluation and Research
Lucillia Winchel - Medical Team Leader for Addiction Products, FDA Center for Drug Evaluation and Research
Andrea Leonard Siegel - Director of Nonprescription Clincial Evaluation, FDA Center for Drug Evaluation and Research
Corrine Huston - Senior Medical Advisor, FDA Center for tobacco Products
Eric Lindblom - Director of Policy, FDA Center for tobacco Products
Testimony
1 of 4 (FDA's Grail Sipes 0:00-0:08, Gregory Conley 0:08-0:15, Lorie McClung 0:15-0:23, Carl Phillips 0:23-0:39, Linc Williams 0:40-1:00, CASAA's Elaine Keller 1:00-1:14, SRNT's Jonathan Foulds 1:14-1:47)
https://collaboration.fda.gov/p98191651/?launcher=false&fcsContent=true&pbMode=normal
2 of 4 (ATTUD's Michael Steinberg 0.00-0.10, CTFK's Danny McGoldrick 0.11-0.17, ACS' Angela Jones 0.18-0.24, Legacy's David Abrams 0.24-1.10, Smokefree Pennsylvania's Bill Godshall 1:11-1:28, TCLC's Kathleen Dachille 1:28-1:37)
https://collaboration.fda.gov/p95861884/?launcher=false&fcsContent=true&pbMode=normal
3 of 4 (ACSH's Gil Ross 0:00-0:11, Scott Ballin 0:12-0:22, Altria's James Dillard 0:22-0:37, Johnson & Johnson's James Walmsley 0:38-1:09, GlaxoSmithKline's Howard Marsh 1:09-1:38, What A Smoke's Mark Anton 1:38-1:47)
https://collaboration.fda.gov/p36279658/?launcher=false&fcsContent=true&pbMode=normal
4 of 4 (Blue Mist vaping's Robert Jack 0:00-0:08, American E-Liquid Manufacturing Standards Association's Lou Ritter 0:08-0:32, Legacy's David Abrams 0:33-0:36)
https://collaboration.fda.gov/p20988129/?launcher=false&fcsContent=true&pbMode=normal
As 13 tobacco harm reduction advocates (including 7 e-cigarette consumers and 2 vendors) educated the FDA panel about THR and THR products, 2 drug company representatives and 5 or 6 drug industry funded groups urged the FDA to fast track approval for NRT and other drug industry products.
While the FDA panelists either didn't ask any questions or asked "gotcha" questions to THR advocates in an attempt to trick, embarrass and/or discredit them, those same FDA panelists asked many friendly "softball" questions to drug industry representatives and drug industry funded promoters of drug industry products.
Grail Sipes - Senior Regulatory Counsel, Office of Regulatory Policy, FDA Center for Drug Evaluation and Research
Sandra Queer - Deputy Director, Office of New Drugs, FDA Center for Drug Evaluation and Research
Chistine Wing - Acting Deputy Director, Office of Drug Evaluation, FDA Center for Drug Evaluation and Research
Bob Rappaport - Director, Division of Anesthesia, Analgesia and Addiction Products, FDA Center for Drug Evaluation and Research
Lucillia Winchel - Medical Team Leader for Addiction Products, FDA Center for Drug Evaluation and Research
Andrea Leonard Siegel - Director of Nonprescription Clincial Evaluation, FDA Center for Drug Evaluation and Research
Corrine Huston - Senior Medical Advisor, FDA Center for tobacco Products
Eric Lindblom - Director of Policy, FDA Center for tobacco Products
Testimony
1 of 4 (FDA's Grail Sipes 0:00-0:08, Gregory Conley 0:08-0:15, Lorie McClung 0:15-0:23, Carl Phillips 0:23-0:39, Linc Williams 0:40-1:00, CASAA's Elaine Keller 1:00-1:14, SRNT's Jonathan Foulds 1:14-1:47)
https://collaboration.fda.gov/p98191651/?launcher=false&fcsContent=true&pbMode=normal
2 of 4 (ATTUD's Michael Steinberg 0.00-0.10, CTFK's Danny McGoldrick 0.11-0.17, ACS' Angela Jones 0.18-0.24, Legacy's David Abrams 0.24-1.10, Smokefree Pennsylvania's Bill Godshall 1:11-1:28, TCLC's Kathleen Dachille 1:28-1:37)
https://collaboration.fda.gov/p95861884/?launcher=false&fcsContent=true&pbMode=normal
3 of 4 (ACSH's Gil Ross 0:00-0:11, Scott Ballin 0:12-0:22, Altria's James Dillard 0:22-0:37, Johnson & Johnson's James Walmsley 0:38-1:09, GlaxoSmithKline's Howard Marsh 1:09-1:38, What A Smoke's Mark Anton 1:38-1:47)
https://collaboration.fda.gov/p36279658/?launcher=false&fcsContent=true&pbMode=normal
4 of 4 (Blue Mist vaping's Robert Jack 0:00-0:08, American E-Liquid Manufacturing Standards Association's Lou Ritter 0:08-0:32, Legacy's David Abrams 0:33-0:36)
https://collaboration.fda.gov/p20988129/?launcher=false&fcsContent=true&pbMode=normal
As 13 tobacco harm reduction advocates (including 7 e-cigarette consumers and 2 vendors) educated the FDA panel about THR and THR products, 2 drug company representatives and 5 or 6 drug industry funded groups urged the FDA to fast track approval for NRT and other drug industry products.
While the FDA panelists either didn't ask any questions or asked "gotcha" questions to THR advocates in an attempt to trick, embarrass and/or discredit them, those same FDA panelists asked many friendly "softball" questions to drug industry representatives and drug industry funded promoters of drug industry products.