Washington, DC, USA, 8 September 2015 – Highly-regarded healthcare regulatory attorney Neil O'Flaherty has joined Baker & McKenzie's North American Healthcare Industry Group as a partner, adding nearly 25 years of experience in a range of FDA regulatory matters.

Based in Washington, DC, Mr. O'Flaherty has worked extensively on FDA device establishment registration, product listing, clinical trial, marketing application, adverse event reporting, labeling, import, export, and enforcement issues. He has addressed these issues for regulated industry and trade associations and in the context of Securities and Exchange Commission filings and various business transactions, including mergers, acquisitions and licensing agreements.

"Neil has earned an excellent reputation as a seasoned FDA lawyer, and he is well-known for his regulatory expertise," said Rick Hammett, the Firm's North American Managing Partner. "His extensive knowledge of the complexities related to FDA device regulations will be an invaluable boost to the services we offer multinationals doing business in the healthcare space."

Mr. O'Flaherty has spoken domestically and internationally, and written extensively, on medical devices and other FDA-related topics, including: FDA regulation of mobile medical apps, other medical software products and in vitro diagnostics; FDA inspectional and enforcement authority; FDA device clinical trial requirements; FDA device regulatory obligations of hospitals; and the impact of FDA device law on business transactions and agreements.

"The convergence of technology and healthcare is happening at a rapid pace, and an increasing number of our clients are seeking FDA regulatory advice, from medical devices and software to clinical trials and business transactions," said Bill Richardson, chair of the North American Healthcare Industry Group. "We are very pleased to have Neil join our team, using his deep experience in FDA matters and the healthcare field to provide strategic advice to our clients."

Mr. O'Flaherty has provided assistance to and collaborated with various medical device industry and health care groups, including providing guidance on device tracking, medical software, and device reclassification matters. His practice also includes legal matters relating to FDA regulation of human cellular and tissue-based products (HCT/Ps).

"Baker & McKenzie's global platform will allow me to enhance the FDA regulatory services I offer my clients, and I look forward to bringing my experience to medical device, medical technology and other healthcare companies seeking advice on a range of FDA regulatory issues," said Mr. O'Flaherty. "I am very happy to join the team."

Baker & McKenzie's Global Healthcare Industry Group comprises more than 450 seasoned industry lawyers operating out of a network that spans 47 countries, serving pharmaceutical, medical device, biotech, and other healthcare companies across a variety of areas, including: M&A and corporate transactions; tax; compliance and regulation; antitrust; disputes, anticorruption, and intellectual property.

The group has advised on a number of recent high-profile M&A transactions in the healthcare industry, including Merck's $9.5 billion acquisition of Cubist, Baxter's spinoff of its biopharmaceutical division, and Catamaran's $12.8 billion sale to UnitedHealth Group. Chambers Global 2015 took note of the Firm's "extensive global network capable of handling all issues arising in the life sciences sector.”

The Group is very active across EMEA, Asia-Pacific and the Americas, and in addition to life sciences lawyers, it includes regulatory affairs professionals, scientists and past in-house counsel. The team focuses on providing innovative advice on pipeline and geographic expansions in emerging markets, executing multi-jurisdictional mergers, acquisitions and reorganizations and navigating regulatory and compliance risks.

Mr. O'Flaherty is the latest in a series of prominent lateral hires to join the Firm in Washington, DC. In recent months, trade compliance practitioner Maurice Bellan and transfer pricing attorney Barbara Mantegani joined the office, as did litigator Edward "Teddy" Baldwin and anti-corruption compliance lawyer Howard Weissman. Highly regarded securities litigator Richard “Rick” Kirby also recently joined.

Mr. O'Flaherty joins Baker & McKenzie from Olsson Frank Weeda Terman Matz P.C. He received his B.A. from the University of Notre Dame and his J.D. from Loyola University Chicago School of Law.

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