The FDA has flagged three third-party labs that submitted device testing data that may have falsified, invalid or copied from ...

The US Food and Drug Administration (FDA) has issued a draft guidance outlining how manufacturers can ensure the data integrity of bioavailability (BA) and bioequivalence (BE) studies to support ...

The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and potentially unreliable paper-based ...

The Food and Drug Administration's (FDA) drug review arm has proposed withdrawing approval for Amgen Inc.’s AMGN Tavneos (avacopan), citing concerns over data integrity, lack of proven effectiveness, ...

The US Food and Drug Administration (FDA) has issued warning letters to a device maker and several drug makers for failing to ...

The U.S. Food and Drug Administration has flagged data integrity, manufacturing and maintenance lapses at one of Dabur India's plants following an inspection earlier this year, according to an ...

The FDA recently announced that it had identified “significant data integrity and study conduct concerns” in various bioequivalence studies conducted by the India-based contract research organization, ...

The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...

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 ...

DUBLIN--(BUSINESS WIRE)--The "Data Integrity by Design and Pharma 4.0: Next-Gen Techniques to Approach GxP Systems, and FDA Compliance" training has been added to ResearchAndMarkets.com's offering.

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 ...