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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.
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09 January 2024
On January 5, 2024, the U.S. Food and Drug Administration (FDA) authorized Florida’s proposal under the Section 804 Importation Program (SIP) to allow Florida to proceed to the next...
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09 November 2023
The U.S. Federal Trade Commission (FTC) announced that it issued warning letters to 10 drug manufacturers and challenged the Orange Book listings for around 100 patents under the U.S. Food...
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17 October 2023
The U.S. Food and Drug Administration (FDA) recently issued new revised draft guidance on “Labeling for Biosimilar and Interchangeable Biosimilar Products,” which most notably...
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13 October 2023
The U.S. Food and Drug Administration (FDA) generic drug program has launched a new pilot program to offer meeting opportunities to generic drug applicants who intend to use...
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31 May 2023
The Supreme Court of the United States has denied certiorari in the Teva v. GSK “skinny labeling” case, leaving intact the Federal Circuit’s August 2021 decision, which we ...
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19 January 2023
Last week, the U.S. Court of Appeals for the D.C. Circuit upheld the district court’s ruling granting the U.S. Food and Drug Administration (FDA) summary judgment against Sandoz,...
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07 December 2022
The U.S. Food and Drug Administration (FDA) recently published the draft guidance “Sameness Evaluations in an ANDA – Active Ingredients,” which aims to assist applicants...
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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...
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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...
