NEW TEXTS THIS WEEK - Drug Information Association
NEW TEXTS THIS WEEK - Drug Information Association
NEW TEXTS THIS WEEK - Drug Information Association
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This document provides information to assist companies with the preparation of the<br />
Summary of Pharmacovigilance Systems (SPS). The SPS is an invaluable tool used by the<br />
Pharmacovigilance Inspectorate of the MHRA to aid planning and preparation for a<br />
forthcoming pharmacovigilance system inspection. Following the inspection, companies<br />
should view ... (Abstract truncated to see more please, go to the document!)<br />
USA<br />
USA - AdComm Profiles: Biography of Judith Kramer, MD, MS - Member of the <strong>Drug</strong><br />
Safety and Risk Management Advisory Committee, 10/24/2006 - 05/31/2010<br />
This document contains the biography of Judith Kramer, MD, MS, Member of the <strong>Drug</strong><br />
Safety and Risk Management Advisory Committee for the period 10/24/2006 - 05/31/2010.<br />
USA - AdComm Profiles: Biography of Sander Greenland, Dr., PhD - Member of the<br />
<strong>Drug</strong> Safety and Risk Management Advisory Committee, 06/01/2006 -<br />
05/31/2010<br />
This document contains the biography of Sander Greenland, Dr., PhD - Member of the <strong>Drug</strong><br />
Safety and Risk Management Advisory Committee, 06/01/2006 - 05/31/2010.<br />
USA - AdComm Profiles: Biography of Sean Hennessey, PharmD, PhD - Member of<br />
the <strong>Drug</strong> Safety and Risk Management Advisory Committee, 10/24/2006 -<br />
05/31/2009<br />
This document contains the biography of Sean Hennessey, PharmD, PhD, Member of the<br />
<strong>Drug</strong> Safety and Risk Management Advisory Committee for the period 10/24/2006 -<br />
05/31/2009<br />
USA - AdComm Profiles: Biography of Susan R. Heckbert, MD, PhD - Member of the<br />
<strong>Drug</strong> Safety and Risk Management Advisory Committee, 10/24/2006 -<br />
05/31/2010<br />
This document contains the biography of Susan R. Heckbert, MD, PhD, Member of the <strong>Drug</strong><br />
Safety and Risk Management Advisory Committee for the period 10/24/2006 - 05/31/2010.<br />
USA - AdComm Profiles: Biography of Timothy S. Lesar, PharmD - Member of the<br />
<strong>Drug</strong> Safety and Risk Management Advisory Committee, 10/24/2006 -<br />
05/31/2009<br />
This document contains the biography of Timothy S. Lesar, PharmD, Member of the <strong>Drug</strong><br />
Safety and Risk Management Advisory Committee for the period 10/24/2006 - 05/31/2009.<br />
USA - AdComm Voting: Voting History of Pankaj. J. Pasricha - Member of the<br />
Gastrointestinal <strong>Drug</strong>s Advisory Committee, 09/27/2005 - 06/30/2009<br />
This document contains the voting history of Pankaj. J. Pasricha, Member of the<br />
Gastrointestinal <strong>Drug</strong>s Advisory Committee for the period 09/27/2005 - 06/30/2009.<br />
USA - AdComm Voting: Voting History of Sean Hennessey, PharmD, PhD - Member<br />
of the <strong>Drug</strong> Safety and Risk Management Advisory Committee, 10/24/2006 -<br />
05/31/2009<br />
This document contains the voting history of Sean Hennessey, PharmD, PhD, Member of the<br />
<strong>Drug</strong> Safety and Risk Management Advisory Committee for the period 10/24/2006 -<br />
05/31/2009<br />
USA - Biologics License Application (BLA) (Supplemental Approval): EPOGEN,<br />
PROCRIT (epoetin alfa) - Approval Letter and Labeling, 09-Mar-2007<br />
This biologics license application supplement, BLA 103234/5122, provides for the use of
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