All About FDA Data Integrity by Design Course: What is Next for the Modernization of the Processes Involved in Compliance for FDA-regulated Systems (ONLINE EVENT: December 9-10, 2024/ON-DEMAND ...

Fresh concerns have emerged about the platelet studies underpinning the FDA approval of ticagrelor, AstraZeneca's ...

Dublin, Nov. 26, 2024 (GLOBE NEWSWIRE) -- The "All About Data Integrity by Design" training has been added to ResearchAndMarkets.com's offering. This webinar is intended for those involved in ...

Blockchain-backed data integrity offers a superior, faster and more cost-effective alternative, warranting the FDA’s consideration for incorporation into 21 CFR Part 11.

The complexity of R&D data, processes, and technologies increases the risk of data integrity violations, as highlighted by the FDA's reports of increasing violations in the pharmaceutical industry.

During an April 2023 inspection at Raptim facilites in Nava Mumbai, India, FDA inspectors found “objectionable conditions” that led them to conclude the company falsified data in testing for ...

Data integrity is crucial in the pharmaceutical industry, strengthening drug development efficacy, scientific research accuracy, and patient safety.

The FDA has issued repeated warnings about the growing problem of data integrity violations, particularly at foreign testing facilities. Last year, the agency called on device sponsors to adopt ...

The FDA remains committed to taking appropriate actions to address ongoing data integrity concerns. Today, the FDA posted six warning letters to companies responsible for introducing unapproved ...

Based on “mounting evidence,” the FDA said, some U.S. companies did not inform trial participants that their living cells ...