Former FDA Official Steven Niedelman Joins Crowell & Moring Health Care Group

Washington, D.C. - January 28, 2009: 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, and the firm's focus on FDA-related matters is growing. I'm honored to be part of their diverse team and to work to help clients create well-rounded approaches to their FDA concerns," said Niedelman.

Before serving as deputy associate commissioner of the ORA, Niedelman was acting director of the Office of Enforcement, where he served as deputy director from July 2001 to September 2002. Niedelman was responsible for developing and assuring compliance with agency policies, processing of enforcement actions, managing recalls, providing information to domestic and foreign governments about the suitability of a firm's ability to provide compliant products and to develop and implement the Quality Management System throughout ORA. Previously, Niedelman spent 24 years at the Center for Devices and Radiological Health, where he held management positions throughout the Office of Compliance. Niedelman graduated from the College of Emporia ( Kan.) in 1971 with a bachelor's degree in biology and chemistry.

Crowell & Moring LLP is an international law firm with more than 450 lawyers practicing in litigation, antitrust, government contracts, health care, corporate, intellectual property and a variety of other practice areas. More than two-thirds of the firm's attorneys regularly litigate disputes on behalf of domestic and international corporations, start-up businesses, and individuals. Crowell & Moring's extensive client work ranges from advising on one of the world's largest telecommunications mergers to representing governments and corporations on international arbitration matters. Based in Washington, D.C., the firm also has offices in New York, London, Brussels, Los Angeles, and Irvine, CA.