On December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major ...

Built-in data integrity is a bare minimum requirement in today’s BioPharmaceutical manufacturing. Good Manufacturing Practices (GMP) regulations of the Food and Drug Administration (FDA) highlight the ...

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, ...

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 ...

The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...

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 ...

DUBLIN--(BUSINESS WIRE)--The "Data Integrity and Document Management Training Course" conference has been added to ResearchAndMarkets.com's offering. Document management and data integrity are a key ...

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 ...

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 ...