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Podcast: Talking the cure
12 July 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...
Publications
News
FDA publishes long-awaited clinical trial diversity guidance
29 June 2024
The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations ...
News
FDA publishes long-awaited clinical trial diversity guidance
28 June 2024
The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations ...
News
FDA Platform Technology Designation Program aims to speed development of drugs, biological products
04 June 2024
The U.S. Food and Drug Administration (FDA) has issued draft guidance on its “Platform Technology Designation Program,” which aims to streamline drug development, manufacturing, ...
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Center for Clinical Trial Innovation furthers FDA’s diversity goals, rare disease drug development
19 April 2024
The U.S. Food and Drug Administration (FDA) has announced the establishment of the “Center for Drug Evaluation (CDER) Center for Clinical Trial Innovation” (C3TI). C3TI is...
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How to use a Data Monitoring Committee in clinical trials: FDA invites industry comment
21 February 2024
Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring...
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FDA permits IRB informed consent waivers for minimal risk clinical trials
09 January 2024
The U.S. Food and Drug Administration (FDA) has published a final rule on “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical...
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FDA permits IRB informed consent waivers for minimal risk clinical trials
09 January 2024
The U.S. Food and Drug Administration (FDA) has published a final rule on “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical...
News
FDA clinical trial diversity workshop reveals agency’s expectations for sponsors
08 December 2023
On November 29 and 30, the U.S. Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative, hosted a public workshop on ways to increase the...
