Blogs

CBER maps modernization plan to handle surge in research and applications.

The ‘skinny’ user fee reauthorization tables multiple high-profile proposals.

Agency releases a series of new guidances to advance the reliability of patient-focused tools and methods.

Robert Foster, CEO of Hepion Pharmaceuticals, discusses strategies for being competitive in the current economic environment.

Seek pared-down measure in funding bill to avert shutdown.

Barbara Lopez Kunz, president, and global chief executive at DIA, discusses key themes on the current state of the clinical trials industry and its future.

Agency officials express associated concerns around clinical trial data reliability and quality.

Raj Indupuri from eClinical Solutions and Douglas Barta from Cerevel Therapeutics discuss how a digital clinical architecture is ideal for modern researchers and trials.

Administration launches national manufacturing initiative, with aim to reduce US reliance on biomedicine from China and other regions.

Decentralized trials provide promise for lowering barriers in participation, but industry must continue to be proactive in patient centricity.

Danielle Mitchell, Founder of Black Women in Clinical Research, discusses how her foundation bridges the gap between minority professionals and clinical trials.

In countdown to renewal deadline, agency already feeling the effects of still-unclear legislative fate.

While DCTs continue to take hold on industry, questions remain.

Risk-reward tolerance standing in way of underperforming trials for sponsors.

Andrea Zobel, PhD, Senior Director of Personalized Supply Chain at AmerisourceBergen’s World Courier, and Graham Wylie, MBBS, Executive Chairman & Founder of the Medical Research Network (MRN), discuss the demand for DCTs, challenges surrounding them, and what their future holds.

Commission pushes for a “more unified” approach to drug development following a period of fragmented coordination during the pandemic.

Orientation pursuits hit high gear as formal rule compliance inches closer.

In this interview, Patrice Matchaba, MD, President of Novartis US Foundation discusses how the biopharmaceutical industry can regain the trust of minorities.

Pharma loses battle to block price negotiations, but implementation faces many challenges.

Newly unveiled workplan focuses on harnessing the impact of big data on drug development—and ultimately public health.

Better clinical data needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.

Citing strong reporting results, hybrid model to continue supplementing on-site inspections.

The scope of RWE’s use in developing and approving new medicines is pitting key healthcare stakeholders against each other.

With debate swirling around products cleared through this pathway, reforms and tighter oversight likely.

Ken Getz, executive director and research professor at the Tufts Center for the Study of Drug Development, discusses the value of breakthrough findings with ROI and eNPV models.

Work across varying therapeutic areas and new technology among reasons why CROs are qualified to advance model.

New online platform, Clinical Trial Guide seeks to improve access.

Largely discarded topic beginning to grab hold in policy discussions.