Hogan Lovells | USA | 28 Jun 2022
Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Considerations for Rescinding Breakthrough Therapy Designation,”…
Hogan Lovells | USA | 1 Oct 2021
Recently, the U.S. Food and Drug Administration’s (FDA’s) Office of Orphan Product Development published the four-page final guidance “Interpreting…
Hogan Lovells | USA | 19 Aug 2021
Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC)…
Hogan Lovells | USA | 27 Apr 2021
On April 23, U.S. President Biden signed into law two bills meant to lower prescription drug prices by limiting new drug exclusivity awards and…
Hogan Lovells | USA | 20 Jan 2021
On January 5, 2021, President Trump signed into law H.R. 1503, the "Orange Book Transparency Act of 2020," which amends provisions governing the types…
Hogan Lovells | USA | 14 Dec 2020
The U.S. Food and Drug Administration (FDA) recently finalized its guidance entitled “Requesting Food and Drug Administration Feedback on Combination…
Hogan Lovells | USA | 28 Oct 2020
The U.S. Court of Appeals for the Federal Circuit (CAFC) recently decided (2-1) in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. that a…
Hogan Lovells | China, European Union, Japan, etc. | 19 Feb 2020
Japan is the world’s third largest Pharmaceutical market, and commentators Currently expect it to reach a value of US$105 Billion by 2021 (and US$109…
Hogan Lovells | USA | 29 May 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)…
Hogan Lovells | USA | 22 Oct 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…