Hyman Phelps and McNamara
Brian J. Donato
Senior Counsel
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(202) 737-5600
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A.B., Manhattan College
J.D., University of Virginia School of Law

Bar Admissions
District of Columbia

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Brian J. Donato began his career at Hyman, Phelps & McNamara, P.C. providing information about various legal issues related to the Federal Food Drug and Cosmetic Act and FDA's regulations and similar laws and regulations of the State of California.

Before joining Hyman, Phelps & McNamara in 1991, Mr. Donato practiced law in firms he founded in Virginia and in Florida. From 1976 to 1980, he served as General District Court Judge for Albemarle County, Virginia. He was Chief Judge for all of the General District Courts in the Sixteenth Judicial District of Virginia in 1978 and 1979. He served as Lecturer at the University of Virginia School of Law from 1978 through 1988. Since 1982, he has been a faculty member at the University's Annual Trial Advocacy Institute.

Professional Affiliations
Line Officer, United States Navy, 1963-1967

Awards & Recognition
FDA Commissioner's Special Citation
Award from the Food and Drug Law Institute
Award from the Regulatory Affairs Professionals Society
Award from The Orange County Regulatory Affairs Discussion Group
The William J. Brennan, Jr. Award from The University of Virginia School of Law

Speaking Engagements    -    see fewer speaking engagements
•  Medical Device: The FDA’s Role in Your Case, September 12, 2017
•  CLE Telephone Seminar on the Food Safety Modernization Act, 2-hour CLE telephone seminar that will provide an overview of the Food Safety Modernization Act and its anticipated impact on food businesses., October 16, 2014
•  FDLI International Conference - China-US Updates in Food and Drug Law, Panelist for session on "Enforcement Developments in China and U.S.: Critical Updates and Key Issues", October 15 - 16, 2013
•  FDA-OCRA Educational Conference, June 16 - 17, 2010
•  MAGI 2010 Clinical Research Conference, May 23 - 26, 2010
•  OCRA Design Controls for Devices and Drugs, September 9, 2009
•  Virginia CLE Webcast on Enforcement Powers and Practices of the U.S. Food and Drug Administration, August 5, 2009
•  Florida Medical Device Symposium, April 7 - 8, 2009
•  Clinical Device Group Webinar, FDA Inspections of Sponsors or Manufacturers, March 18, 2009