William A. McConagha

Bill's representative experience includes advising:

• A global medical device company, as lead FDA enforcement and government strategies counsel, on confronting two Section 483s, a related warning letter, two simultaneous congressional investigations, and simultaneous FDA and DOJ enforcement investigations*
• A startup pharmaceutical company on developing appropriate promotional materials, sample distribution programs, and pharmacovigilance systems for a newly launched drug product*
• A large, publicly traded medical device company on responding to a warning letter and successfully defending a joint FDA-Department of Justice (DOJ) criminal investigation into the alleged sale of misbranded and adulterated products*
• A global vaccine company in preparing for and managing an FDA inspection and responding to a Section 483
• A global medical device company in responding to Section 483s and a Warning Letter
• A large international pharmaceutical company’s US subsidiary on defending a litigation regarding risk evaluation and mitigation strategy (REMS) and a related FDA dispute*
• Several FDA-regulated companies, including a pet food manufacturer, a consumer products company, and a large US-based pharmaceutical company, in conducting internal investigations*
• A large, publicly traded wholesale distributor on compliance with the FDA’s track-and-trace pedigree requirements for prescription drugs*
• Innovative food companies on navigating FDA and US Department of Agriculture (USDA) premarket pathways for cell-cultured meat products*
• A global cosmetic company regarding product labeling and claims
• A large, publicly traded medical products company on developing procedures to comply with FDA’s post-market safety reporting requirements for combination drug-device products*

*Matter handled prior to joining Latham