News
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...
Publications
News
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Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring...
News
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 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...
News
Getting START’ed: New FDA programs aim to advance drugs to treat rare diseases
12 October 2023
On September 29, 2023, the U.S. Food and Drug Administration (FDA or "agency") announced the opportunity for a limited number of sponsors to participate in a new pilot program...
News
Getting START’ed: New FDA programs aim to advance drugs to treat rare diseases
11 October 2023
On September 29, 2023, the U.S. Food and Drug Administration (FDA or "agency") announced the opportunity for a limited number of sponsors to participate in a new pilot program...
News
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The U.S. Food and Drug Administration (FDA) published new draft guidance on “Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical...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
Clinical trial diversity data can be boosted post-approval, FDA guidance explains
21 August 2023
Continuing the trend over the past few years to promote diversity in clinical trials, the U.S. Food and Drug Administration (FDA) has published new draft guidance on “Postmarketing...
