Blogs

EMA operated-Priority Medicines scheme receives update which will expedite response to applicants.

Impact areas that will be closely watched during phase-out include drug testing and authorization, telehealth, and patient access.

Following COVID-19, companies are focused on solutions offering the latest technology and most value to patients.

Tiffany Chow, MD, a specialist in behavioral neurology and senior medical director at Alector, discusses the unique challenges of designing clinical trials for frontotemporal dementia.

Merck presentation at SCOPE 2023 highlights company’s AI-assisted data validation approach.

The hopes for increased transparency in clinical research beginning to take shape as sponsors get up to speed with new reporting obligations.

Europe trade and lobby group says implementation issues related to the legislation could impact 420 trials—and 42,200 patients—over the next three years.

Tom Brazier, director decentralized clinical solutions at mdgroup, explains how to improve the availability and accessibility of decentralized solutions.

John R. Sims, senior vice president and head of global development, and Dawn A. Brooks, director of clinical development; both with Eli Lilly discuss the design of the TRAILBLAZER-ALZ program.

A summary of this year’s key topics and discussions.

The key issues for industry and FDA as the Orphan Drug Act hits its 40th anniversary.

Reformed EMA looks to tackle challenges in drug development, pediatric medicines, and unmet medical need.

The Association of the British Pharmaceutical Industry greets the development with mix of relief and urgency.

Report by the Government Accountability Office calls for ramped-up oversight by FDA of institutional review boards.

Probe targets agency’s role in advising on drug testing and submissions.

Sanjay Shukla, MD, MS, CEO of aTyr Pharma, discusses the company's clinical operations and ongoing Phase III study for pulmonary sarcoidosis.

EMA opens public discussion on envisioned platform to encourage multi-stakeholder interactions and shared understanding.

With industry’s uneven track record in patient representation, sponsors now mandated to submit Diversity Action Plans (DAPs) to FDA for Phase III and pivotal studies.

Proposed realignment of the Office of Regulatory Affairs would impact oversight of drugs and medical devices as well.

Craig Coleman, PharmD, Professor at the University of Connecticut, and the Observational Study in Cancer-Associated Thrombosis for Rivaroxaban (OSCAR) study's principal investigator discusses the ins and outs of the study.

DCTs and RWD among topics for industry to focus on moving into 2023.

Artem Andrianov, CEO of Cyntegrity, discusses the launch of his company's new tool; the Drug Interaction Visualizer.

Formal compliance with EU’s Clinical Trials Regulation takes effect, designed to speed up the application and approval of studies.

Face-to-face meetings will now include in-person and virtual components.

Agency panel backs the use of a common bivalent shot for all patients.

Recent industry advancements such as DCTs, AI, and machine learning are shaping the future of clinical trials.

The issues engulfing compliance with the Clinical Trials Regulation signal that even the best intentions with these types of laws may not be enough to avert unintended consequences.

Latest recommendation places great emphasis on patients.