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Former FDA Official Steven Niedelman Joins Crowell & Moring Health Care Group
Date:1/28/2009

WASHINGTON, Jan. 28 /PRNewswire-USNewswire/ -- Steven M. Niedelman, former deputy associate commissioner for regulatory operations for the U.S. Food and Drug Administration (FDA), has joined the law firm Crowell & Moring LLP as senior consultant focusing on food and drug matters in the Health Care Group. Niedelman is the firm's second major hire in recent months to boost the firm's FDA practice, which also recently gained Cathy L. Burgess, former associate general counsel for the American Red Cross.

"We have significantly enhanced our ability to serve pharmaceutical, medical device, and other clients on the full range of FDA compliance and enforcement matters, and Steve is a tremendous addition to our team. He offers clients decades of FDA experience that will help them achieve swift, practical solutions to concerns that are growing increasingly complex," said Arthur N. Lerner, co-chair of Crowell & Moring's Health Care Group.

Niedelman is a former executive vice president of Quintiles Consulting. Prior to his work at Quintiles, Niedelman served in the FDA for 34 years, holding management responsibility for approximately one-third of all FDA staff and serving as chief operating officer of the Office of Regulatory Affairs' (ORA's) headquarters offices. At ORA, he ensured consistent interpretation and implementation of regulatory policies. He also directed the work of the Office of Regional Operations, Office of Enforcement and Office of Criminal Investigations, as well as FDA's 3,400 field staff responsible for investigative and regulatory laboratory field operations. Among his many duties, he co-chaired the FDA's Compliance Policy Council and served as the point person on regulatory and policy issues involving the medical device industry.

"Crowell & Moring's work in the medical device and life science sectors is comprehensive and sophisticated,
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SOURCE Crowell & Moring LLP
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