N.W., Suite 200
Washington, District Of Columbia 20006
is a senior partner in the firm’s Washington, D.C., office. He has over 25 years of experience interpreting the laws and regulations of the Food and Drug Administration.
Mr. Basile’s current practice includes representing large, medium and small medical device, pharmaceutical and biotechnology companies. Mr. Basile has advised these clients on strategies for obtaining FDA approvals of new products and on compliance issues including criminal investigations, inspections, recalls, labeling issues and proposals to ban or withdraw approval of products. Mr. Basile also has represented clients in litigation with the FDA.
Mr. Basile has published numerous articles on FDA law and is a frequent lecturer on a variety of FDA law issues for the Food & Drug Law Institute and other organizations sponsoring educational programs.
Mr. Basile has served as Chair for the FDA & Life Sciences Practice Group, a member of the firm’s Policy Committee and the Compensation Committee.
Prior to joining King & Spalding, Mr. Basile served as Deputy General Counsel for the Advanced Medical Technology Association, the primary trade association for the medical device industry. Mr. Basile established himself as one of the nation’s leading authorities on the interpretation of the federal laws governing FDA’s regulation of medical devices. Mr. Basile also served in the Chief Counsel’s Office of FDA from 1975-1985 as Associate Chief Counsel for Drugs & Biologics and Associate Chief Counsel for Enforcement. While at the FDA, Mr. Basile had extensive litigation experience, including civil and criminal enforcement cases and major, complex defensive litigation.
Mr. Basile received a B.S. in mechanical engineering from Lafayette College in 1969 and his law degree in 1972 from the National Law Center, George Washington University where he graduated Order of the Coif.
|Areas of Practice||1) FDA & Life Sciences , 2) Crisis Management , 3) Crisis Management: Pharma/Biotech/Med Devices and 4) Healthcare Industry|
|Law School||J.D., George Washington University|
|Education||B.S.M.E., Lafayette College|
|Bar Member / Association||State bar of District of Columbia|
|Most recent firm||King & Spalding LLP|
Ms. Fitzgerald represents employers in a wide range of industries, including the entertainment, financial services, hospitality, manufacturing, retail, and transportation industries.
Ms. Shander advises public and private company clients as well as private equity funds, with an emphasis on mergers and acquisitions, dispositions, and financing transactions.