Bill McConagha, a partner at Skadden Arps, is a nationally recognized attorney in FDA law who has a unique combination of experience in enforcement, regulatory and legislative matters. Mr. McConagha worked for more than 17 years at the Food and Drug Administration (FDA) in a variety of capacities, including an assistant commissioner, a senior attorney in the Office of Chief Counsel (OCC), and as a Health Policy Advisor to the Senate Committee on Health, Education, Labor and Pensions (HELP). He counsels clients on a wide range of regulatory and enforcement issues related to drugs, medical devices, biologicals, foods, and human tissue products.. He has extensive experience with combination products and also specializes in compliance with FDA manufacturing requirements (i.e., GMP, QSR and preventive controls). He has worked on-site at manufacturing facilities located throughout the U.S. and in 15 other countries, and has helped companies develop responses to numerous FDA 483s and Warning Letters. He graduated with honors from Carleton College and Georgetown University Law School.
