July 25th 2025
Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.
Funding Cuts Threaten Diversity in Clinical Research
June 27th 2025In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how recent federal funding cuts are likely to undermine research focused on underrepresented populations, and why long-term investment in community-based studies is essential to closing persistent health equity gaps.
FDA to Launch National Priority Voucher Program to Speed Drug Reviews for Critical Therapies
June 18th 2025Under the new initiative, companies may receive a voucher enabling FDA review to be shortened from the standard 10–12 months to just 1–2 months following final application submission if the drug addresses US national health priorities.
How Trump’s Most Favored Nation Policy Could Impact Funding for Clinical Development
June 4th 2025In this video interview, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discusses the administration’s policy and how it could force pharma companies to reduce funding for clinical R&D.
FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research
May 21st 2025In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.
Current Areas of Focus for Clinical Operations Professionals in Vaccine Trials
May 13th 2025In this video interview, Krinx Kong, chief commercial officer, Cognivia, discusses how clinical operations professionals should be focusing on flexibility, behavioral visibility, and communication in the current landscape of managing vaccine trials.
The Importance of Clinical Trial Oversight when Outsourcing
April 25th 2025In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, shares his key takeaways from Cencora’s recent TMF Leadership Summit and touches on the importance of oversight when working with outside stakeholders.