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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
01 February 2022
With the issuance of its mandate on January 28, 2022, in Catalyst Pharmaceuticals, Inc. v. Becerra, the U.S. Court of Appeals for the Eleventh Circuit has upheld the orphan exclusivity ...
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
07 May 2021
On April 21, 2021, FDA’s Center for Biologics Evaluation and Research (CBER) Director Peter Marks M.D. confirmed that the grace period intended to provide developers of regenerative...
News
11 August 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 to make public a decade of clinical...
News
14 July 2020
On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions ...
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Registered Content
03 March 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 results for products that have been approved...
Hogan Lovells Publications
05 December 2019
Hogan Lovells Publications
09 July 2019
Recalibrating—And Restricting—The Deference Due Federal Agencies’ Interpretations Of Their Own Regulations
News
29 May 2019
Opinion highlights importance of a "clear" record at FDA
