The US Food and Drug Administration (FDA) has warned Chinese drugmaker Jiangsu Hengrui Pharmaceuticals for “serious data integrity violations” tied to shoddy record-keeping as well as lax ...
Editor’s note: This article has been updated to clarify the conference where Jeff Shuren spoke to Focus. WASHINGTON – The US Food and Drug Administration (FDA) is warning medtech sponsors and ...
Data integrity is an ongoing concern across all R&D organizations, no matter what part of the research lifecycle they’re navigating. These concerns extend beyond the potential for delayed timelines or ...
Chris is the CTO and Co-Founder of Scientist.com, a Research Platform helping drug discovery researchers develop new therapies. The FDA’s adoption of electronic submissions raised concerns about data ...
Fresh concerns have emerged about the platelet studies underpinning the FDA approval of ticagrelor, AstraZeneca's multibillion-dollar heart drug. A new BMJ investigation reveals data discrepancies, ...
The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and potentially unreliable paper-based ...
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has issued General Correspondence Letters to two third-party testing companies in China after uncovering falsified or otherwise invalid ...
Data integrity is a hot topic for regulators and auditors, making it important to understand data integrity criteria for the laboratory – and apply the principles correctly. A free on-demand webinar ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results