Susan M. Cook
Hogan Lovells
Articles
HHS now requires public posting of a decade of clinical trial results that were previously exempted
USA - August 11 2020 Earlier this year, we wrote about a ruling by the U.S. District Court for the Southern District of New York that, if upheld, would require companies...
Court ruling would require public posting of a decade of clinical trial results that HHS regulation had exempted
USA - March 3 2020 A new ruling by the U.S. District Court for the Southern District of New York could require companies to make public a decade of clinical trial...
Bert Lao, David Horowitz, Robert Church, William F. Ferreira.
It’s Auer Over But The Shouting
USA - July 10 2019 The Supreme Court recently issued its long-awaited decision in Kisor v. Wilkie, No. 18-15. In a deeply divided decision generating four separate...
U.S. Supreme Court rules judges must decide whether preemption applies, and clarifies when it does
USA - May 29 2019 On 20 May the U.S. Supreme Court unanimously ruled that federal preemption questions arising under the Federal Food, Drug, and Cosmetic Act (FD&C Act)...
Heidi Gertner, Sydney Fairchild, Lauren S. Colton, David M. Fox, Philip Katz.
A new normal in the pharmaceutical industry: How to fight back when your competitor can't stop fibbing
USA - October 22 2018 Speaking in September at a discussion hosted by the Alliance for a Stronger FDA, Dr. Janet Woodcock provided some candid insight into FDA's...
Heidi Gertner, Meredith Manning, David M. Fox, Susan S. Lee.
