-- (Marketwire) -- 01/18/11 -- International law firm King & Spalding today announced that Steven M. Niedelman, a former high-ranking official at the U.S. Food and Drug Administration, has joined King & Spalding's Washington, D.C., office as lead quality systems and compliance consultant for the firm's leading FDA and life sciences practice.
"With a distinguished career that includes more than three decades at the Food and Drug Administration, Steve adds even more bench strength to our deep FDA and life sciences team," said Edward M. Basile, co-leader of King & Spalding's FDA and life sciences practice. "We welcome Steve to King & Spalding."
Niedelman joins King & Spalding from Crowell & Moring LLP, where he was a senior consultant in its health care group. Previously, he was executive vice president of Quintiles Consulting.
Niedelman specializes in regulatory, enforcement and policy matters involving industries regulated by the U.S. Food and Drug Administration. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure compliance with the requirements of the federal Food, Drug and Cosmetic Act. He also consults with manufacturers, importers, new-product developers and firms facing enforcement actions, helps develop corrective action plans and provides training and guidance to industry professionals on all FDA requirements, including quality systems requirements, inspection preparedness, post-market obligations and management responsibilities.
"King & Spalding represents eight of the top 10 pharmaceutical/biotechnology manufacturers as well as eight of the top 10 medical device manufacturers," said Patrick Morrisey, co-leader of King & Spalding's FDA and life sciences practice. "Steve's experience and skill enhances our ability to serve the needs of those and other clients, and we are very glad that he is part of our team."
Niedelman retired from the FDA in 2006 after a 34-year career in which he held a number of senior management positions, including deputy associate commissioner for regulatory affairs of the FDA, chief operating officer of the Office of Regulatory Affairs and director of the FDA's Office of Enforcement. He helped manage the day-to-day investigative and laboratory operations of the FDA's field staff of nearly 3,400 employees.
At the FDA Niedelman also served as the principle liaison to the Center for Devices and Radiological Health (CDRH), chairman of FDA Compliance Policy Council and was a member of the steering committees for the FDA's Global Harmonization Task Force, FDA/Medical Device Industry Grassroots Initiative, CDRH Post Market Initiative, Pharmaceutical "Current Good Manufacturing Practices for the 21st Century" Initiative and Counterfeit Drug Task Force.
Niedelman received a bachelor of arts degree in biology and chemistry from the College of Emporia (Kansas).
"I am very excited at this point in my career to be part of King & Spalding's talented FDA and life sciences team and look forward to helping serve the firm's growing roster of major clients in the medical device, pharmaceutical, biologics, food and other industries," said Niedelman.
King & Spalding has one of the broadest and deepest benches of lawyers, scientists and consultants in the United States specializing in the representation of pharmaceutical, biotechnology and medical technology companies. More than 125 lawyers and professionals devote all or a substantial portion of their practices to clients in these industries, with specialized experience at every stage of the product life cycle -- from emerging growth company counseling on intellectual property and clinical trials, through licensing and finance, to FDA approval, manufacturing, marketing, commercial and post-approval regulatory, transactional, and litigation matters. Lawyers in King & Spalding's FDA and life sciences practice provide counseling on a full array of FDA and related matters involving medical devices, pharmaceuticals, OTC drugs, biologics, biotechnology, food, animal drugs and consumer products.
About King & Spalding
Celebrating 125 years of service, King & Spalding is an international law firm with more than 800 lawyers in Abu Dhabi, Atlanta, Austin, Charlotte, Dubai, Frankfurt, Geneva, Houston, London, New York, Paris, Riyadh (affiliated office), San Francisco, Silicon Valley, Singapore and Washington, D.C. The firm represents half of the Fortune 100 and, according to a Corporate Counsel survey in August 2009, ranks fifth in its total number of representations of those companies. For additional information, visit www.kslaw.com.