• where experts go to learn about FDA
  • Anne K. Walsh

    • Yates’ Update on Yates MemoMay 16th, 2016

      By Anne K. Walsh & John R. Fleder – DOJ Deputy Attorney General Sally Q. Yates spoke last week before the New York City Bar Association White Collar Crime Institute to provide an update on the DOJ policy she announced in September 2015, about which we …

    • The Government Really Means It This Time (Part II)November 22nd, 2015

      By Anne K. Walsh & John R. Fleder – As we reported in September, DOJ’s Deputy Attorney General Sally Quillian Yates released a seven-page memorandum announcing DOJ’s reinforced efforts to bring cases against individuals. She anticipated that DOJ would revise the U.S. Attorney’s Manual (USAM) to …

    • Warner-Chilcott Resolution Includes Indictment of PresidentNovember 12th, 2015

      By Anne K. Walsh & John R. Fleder – It has been just over a month since the Department of Justice, via the “Yates Memorandum,” reemphasized its commitment to pursue individuals when dealing with corporate misconduct, reported here.  Ever since then, FDA-regulated industry has been awaiting …

    • The Government Really Means It This TimeSeptember 22nd, 2015

      By Anne K. Walsh & John R. Fleder – The government has long repeated the mantra that it will hold individuals personally liable for the activities of their corporate employer.  In the FDA-regulated arena, the government has been bolstered by the U.S. Supreme Court precedents set …

    • No End to Aggressive Investigative TechniquesJuly 7th, 2011

      By Anne K. Walsh & John R. Fleder – Companies must proactively prepare for the strong arm tactics the government employs to investigate companies regulated by FDA.  A recent case demonstrates that the federal government can act with little regard to companies seeking to represent themselves by …