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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.
News
28 June 2022
Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Considerations for Rescinding Breakthrough Therapy Designation,” which outlines how FDA will...
News
01 October 2021
Recently, the U.S. Food and Drug Administration’s (FDA’s) Office of Orphan Product Development published the four-page final guidance “Interpreting Sameness of Gene...
News
19 August 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) affirmed (2-1) upon rehearing its...
News
27 April 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 promoting biosimilars. The Ensuring...
News
23 February 2021
Companies in the life sciences and health care industry navigated unparalleled challenges in 2020. The pandemic forced the development and adoption of new technologies and innovations...
News
20 January 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 of patents and...
News
14 December 2020
The U.S. Food and Drug Administration (FDA) recently finalized its guidance entitled “Requesting Food and Drug Administration Feedback on Combination Products,” stressing as it...
News
28 October 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 labeling carve-out by a generic drug...
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Registered Content
18 March 2020
The public comment period recently closed for the draft guidance “Requesting FDA Feedback on Combination Products,” which describes the methods by which combination product...
