William McConagha

Bill McConagha, a former Associate Chief Counsel and Assistant Commissioner at the US Food and Drug Administration (FDA), is a nationally recognized life sciences attorney who advises clients on a range of complex issues spanning the FDA-regulated product life cycle, from premarket development and clinical trials, through product launch, post-market safety reporting, and manufacturing requirements, including cGMP.

Bill draws on extensive federal government experience to represent companies across the FDA’s regulatory spectrum, including companies that manufacture or market pharmaceuticals, medical devices, biologics, foods, tobacco, and cosmetics. He helps clients navigate:

• • FDA compliance, including preparing for and managing FDA inspections, responding to FDA 483s and warning letters, and complying with post-market safety requirements
  • FDA regulatory issues, including pre- and post-market requirements and related commercial activities such as product importation and supply chain oversight
  • FDA-related diligence and regulatory counsel, including negotiating representations and warranties, in corporate transactions
  • Internal investigations involving clinical trial oversight, post-market safety reporting, and risk management

A recognized industry leader, he worked at FDA for 17 years in various high-level roles and served as a Health Policy Advisor on the Senate Committee on Health, Education, Labor, and Pensions (HELP).

During his tenure in public service, he received the following awards: Secretary’s Award for Distinguished Service, Department of Health and Human Services; Excellence in Legal Services, Office of the General Counsel, Department of Health and Human Services; Commissioner’s Special Recognition Award, FDA; Commissioner’s Special Citation, FDA; and the Director’s Award for Outstanding Service, FDA’s Office of Criminal Investigations.