Regulatory

Despite the setback with the Oncologic Drugs Advisory Committee vote, GSK emphasizes the unmet need in multiple myeloma and highlights global momentum behind Blenrep combination approvals.

In this video interview, Ramita Tandon, chief biopharma officer at Walgreens, discusses the operational investments required to activate pharmacies as clinical trial sites, including staff training, regulatory coordination, and patient-facing technology.

Outdated regulations and inflexible sponsor processes are hampering clinical trial recruitment, but empowering sites with modern, compliant marketing tools could turn the tide.

In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how clinical trial sites and sponsors are responding to funding constraints by turning to telemedicine, cost-containment strategies, and increased reliance on industry-sponsored research.

In this video interview, Kyle McAllister, co-founder, CEO, Trially, explains how staffing reductions caused by clinical trial budget cuts are threatening patient recruitment and retention and warns of the long-term ripple effects on trial timelines and healthcare innovation.

In 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.

In this video interview, Judith Ng-Cashin, MD, chief medical officer, Novotech, explores how CRO partnerships are shifting to deliver greater efficiency, cost-effectiveness, and regulatory insight in response to tightening budgets and an increasingly complex clinical research environment.

As clinical research increasingly relies on RWD to enhance trial design and patient insights, tokenization has emerged as a critical solution for securely linking disparate datasets while protecting patient privacy.

Under 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.

In our June issue, explore how clinical research is adapting to regulatory changes, AI advancements, and modernizing trial designs for improved safety and efficiency.

Balancing the emerging benefits of AI in pharmacovigilance with new responsibilities and demands from regulators in enhancing efficiency and safety.

Advancing more inclusive and representative clinical trials through action and accountability.

Strategies for sponsors in navigating the European Union's new health technology assessment regulation.

In this video interview, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discusses how key stakeholders in clinical research are responding to uncertainty with budget cuts and administrative shifts.

As stakeholders debate fair market value in clinical trial budgeting, a new task force works to align sponsors, CROs, and sites on transparency, sustainability, and efficiency.

Case study highlights how clinical operations teams can overcome complex regulatory and operational hurdles to finish a trial on time and on budget.

Despite positive results from a Phase I/II trial of its investigational pandemic influenza vaccine, mRNA-1018, Moderna’s award for almost $600 million to accelerate vaccine development will be terminated.

In 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.

In this video interview, Ron Lanton, partner, Lanton Law, highlights how tariffs on active pharmaceutical ingredients could affect resources for maintaining and accelerating R&D pipelines.

In this video interview, Ron Lanton, partner, Lanton Law, talks FDA layoffs and their impact on inspections and clinical trial timelines.

In this video interview, Ron Lanton, partner, Lanton Law, discusses how a potential increase in drug costs could affect the clinical research industry.

While randomization is required by regulatory bodies, it is up to the sponsor on how to conduct it.

How digital intake solutions driven by technological advancements can help overcome the challenges of operating across different regulatory markets.

In 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.

In this video interview, Michael Liu, discusses the need for continued monitoring of these medical research cuts to gain a better understanding of exactly what trials they are impacting.