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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...

Bert Lao, David Horowitz, Robert Church.

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...

Cate Stetson, Kyle Druding, Jessica L. Ellsworth.

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.