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Drug Shortages 2012: Rewind, Repeat, Recovery
Program Code:
226
Date:
Tuesday, June 26, 2012
Time:
10:00 AM to 11:30 AM
EST
CHAIR
:
Dr. Kweder has been in her position since 2002, and previously held a number of leadership positions in CDER. Her work focused on improving review processes to build a high performing organization that values scientific rigor, open discourse and high quality decisionmaking.
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PRESENTER
(S):
CDR Emily Thakur has been working with the Drug Shortage Program since February 2011. She joined the FDA in 1999, working in the Office of Generic Drugs. She then joined the Office of Regulatory Policy in 2005. She received her Bachelor of Science degree from Rutgers College of Pharmacy in 1999.
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Commercial responsibility for business specific to institutional markets focusing on injectable presentations. Met with senior FDA and HHS, various industry/patient associations, and congressional leaders in order to seek solutions that would curb and prevent critical drug shortages in the future.
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Laina Bush, HHS, United States
Description
This session will focus on characterizing the current issues surrounding shortages of medically necessary drug products. Speakers will focus on history, repetitive patterns of problems, and our path forward. This will include present initiatives underway and strategies under consideration for effectively dealing with, and mitigating existing drug shortage situations, and for preventing new drug shortages from developing. The respective roles of both industry and the FDA in addressing drug shortage situations will be discussed.
Learning Objectives:
Describe the issues surrounding shortages of medically necessary drug products
Discuss the history, repetitive patterns of problems, and our path forward in dealing with drug shortages.