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Podcast: Talking the cure
11 April 2024
Our team is always thinking about how to foresee and conquer the most significant industry issues facing our clients. In 2020, we launched the podcast "Talking the Cure" where we cover...
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FDA explains “confirmatory evidence” for sponsors seeking approval based on a single clinical trial
03 October 2023
The U.S. Food and Drug Administration (FDA) published new draft guidance on “Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical...
News
Eleventh Circuit decision could significantly expand scope of orphan exclusivity
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
FDA finalizes guidance on Orphan Drug “sameness” of gene therapies
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...
