Regulatory

New survey data show a strong patient preference for fully remote clinical trials, underscoring how convenience, intuitive technology, and FDA-cleared digital tools are reshaping enrollment and retention strategies as decentralized models become a lasting fixture in clinical research.

As highly effective anti-obesity therapies emerge and regulatory expectations evolve, sponsors are adopting innovative trial designs, addressing long-term weight maintenance, monitoring lean mass preservation, and preparing for expanded safety and demographic requirements that will define the next era of obesity R&D.

New FDA guidance signals a major shift for CAR-T development, calling for randomized trials with standard-of-care control groups and clear evidence of superiority over existing therapies, while simultaneously easing REMS requirements to reduce logistical burdens for treatment centers and patients.

AI-driven discovery, EHR-based real-world evidence, and synthetic patient modeling are rapidly reshaping drug repurposing, reducing development timelines, expanding therapeutic applications, and accelerating regulatory acceptance of computational approaches.

Twelve former FDA leaders have publicly challenged the agency’s proposed overhaul of vaccine approvals, sparked by an internal memo linking child deaths to COVID-19 vaccination, arguing the changes threaten evidence-based standards, weaken immunobridging practices, and risk eroding public trust.

The FDA has introduced a secure, agency-wide agentic AI system to support complex regulatory workflows—enhancing reviews, surveillance, and inspections—while maintaining strict data protections and human oversight.

In this Q&A, John Kirk, principal regulatory strategist at Veristat, explains how the FDA’s Commissioner’s National Priority Voucher (CNPV) Program is accelerating operational timelines, tightening cross-functional workflows, and redefining what sponsors and CROs must deliver to secure and execute an ultra-compressed one-to-two-month review.

The company submitted the new dosage for approval based on its Phase III trial results.

Epkinly plus rituximab and lenalidomide is the first bispecific antibody combination FDA-approved for relapsed or refractory follicular lymphoma, backed by Phase III data showing substantially improved disease control over standard therapy.

As biotechs expand their outsourced clinical operations, adopting a CTMS is becoming essential to ensure CRO oversight, regulatory compliance, and real-time visibility across trials and portfolios.

In 2025, both big pharma and biotech are redefining decision-making as AI, real-world evidence, and flexible deal structures accelerate drug development, flatten organizational silos, and close the innovation gap across the life sciences ecosystem.

Ethical and regulatory considerations for safeguarding participants in bispecific antibody clinical trials, and best practices designed to optimize their success.

As decentralized and hybrid trial models expand, eConsent is emerging as a critical tool for improving participant understanding, reducing site burden, and strengthening data integrity through digital automation, accessibility, and regulatory compliance.

How a unified approach to clinical data management, powered by artificial intelligence and advanced analytics, can elevate clinical trial monitoring and redefine how teams assess, act on and learn from data.

With global supply chains inherently vulnerable to trade policy shifts, the consequences for clinical research can be significant without proactive planning. The eight core elements of a tariff contingency plan are outlined.

How a strategic approach to the pre-investigational and investigational new drug application process can be used as a business and clinical catalyst.

Capturing insights from clinical research professionals on the key trends and challenges shaping drug development today, from those in clinical trial operations and site relationships, to technology and AI, and the evolving regulatory and policy terrain.

Regulatory inspections of interactive response technology systems have surged 140% since 2022, signaling intensified global scrutiny of data integrity, randomization, and system validation in clinical trials.

The latest federal shutdown leaves the NIH operating with just one-quarter of its staff to maintain patient care at its Clinical Center, while broader funding cuts and proposed agency consolidations threaten the future stability of US biomedical research.

In today’s high-cost R&D environment, pharma success depends less on cost-cutting and more on evidence-based portfolio decisions, niche-buster strategies, and real-world data-driven indication expansion to maximize both ROI and patient outcomes.

Pharma R&D faces rising trial complexity, high costs, and patient and investigator shortages, driving the need for adaptive models and data-driven strategies to speed therapies to market.

As clinical research becomes increasingly digital, integrating rigorous cybersecurity assessments into CRO selection and qualification is essential to safeguard sensitive data and ensure trial integrity.

In this video interview, Ananth Kadambi, VP of real-world evidence and modeling solutions at Certara, outlines how FDA’s emphasis on overall survival in oncology trials requires stronger safety monitoring, subgroup planning, and patient tracking.

In an era of constant policy change, timely real-world data is emerging as pharma’s most critical tool to track patient access, anticipate shifts in treatment utilization, and improve outcomes in real time.

A quick look at FDA’s 2025 transparency moves, what CRLs are (and aren’t), how FAERS works and its limits, who can report, and where the agency is applying AI.