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Deborah Autor, FDA's Deputy Commissioner for Global Regulatory Operations and Policy, to Join Mylan
Date:4/30/2013

ed, "Mylan has been a leading advocate for ensuring one quality standard, both internally and externally, as evidenced by the company's active role in the development and passage of the FDA Safety and Innovation Act, or FDASIA. I am very excited to be joining an organization whose people demonstrate such extraordinary passion and commitment to quality and access to medicine. I look forward to contributing to Mylan's continued leadership on quality – both from an operational and policy perspective."

Most recently, Autor oversaw the Office of Regulatory Affairs and the Office of International Programs at FDA, with responsibility for 4,400 employees. In this role, she led the implementation of FDA's strategy for addressing the challenges of globalization and import safety. Under Autor's leadership, her organization made great strides in becoming more data-driven, strategic and risk-based, moving closer to its vision of a strong global product safety net in which all food is safe, all medical products are safe and effective, and the public health is advanced and protected.

Prior to assuming the role of deputy commissioner, Autor served for five years as director of the Office of Compliance in FDA's Center for Drug Evaluation and Research (CDER). In that role, she led policymaking and enforcement for key public health programs for drugs, including current good manufacturing practices, human-subject protection and bioresearch monitoring, marketed unapproved drugs, pharmaceutical import and export, Internet and health fraud, over-the-counter monograph compliance, adverse-event reporting, registration and listing, and drug recalls. Under Autor's leadership, CDER's Office of Compliance worked to minimize consumers' exposure to unsafe, ineffective and poor quality drugs.

Autor also served in the CDER Office of Compliance as a senior advisor and as associate director for Compliance Policy. Prior to joining FDA, for seven years, Autor represented the
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SOURCE Mylan Inc.
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