RAPS

Data Integrity in cGMP Drug Manufacturing: FDA Offers New Draft Guidance

The recent influx of concerns over data manipulation and other data integrity questions in India, China and elsewhere has pushed the US Food and Drug Administration (FDA) to put out new draft guidance ...
Applied Clinical Trials Online

FDA Reaffirms GCP Standards Amid Growing Concerns Over Foreign Clinical Trial Data

Senior leaders reiterated that GCP expectations are geography-agnostic, and inadequate inspection access can render foreign ...
RAPS

Data Integrity Q&A: FDA Finalizes Guidance

The US Food and Drug Administration (FDA) on Wednesday finalized its questions and answers guidance on complying with data integrity requirements under current good ...
JD Supra

FDA Issues Draft Guidance on Data Integrity Considerations for Bioavailability and Bioequivalence Studies

The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...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

Data Integrity Governance Webinar: Integrated Data Process Mapping & CSV Strategies to Strengthen Data Integrity, FDA 21 CFR Part 11/820 Compliance, and Risk Governance

Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "Data Process Mapping Tools and Strategies in Data Integrity Governance (Sept 5, 2025)" training has been added to ResearchAndMarkets.com's offering. This ...
Hosted on MSN

FDA review panel challenges Amgen's Tavneos approval on efficacy, data grounds

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, ...
News Medical

The critical role of data integrity in ensuring pharmaceutical quality

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

Addressing Data Integrity Challenges in Medical Device Submissions

Cathy Burgess, Benjamin Wolf, Jong Ho "Philip" Won, Ph.D. The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...
Drug Store News

What’s complicating good data practices and data integrity?

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 ...
Business Wire

Data Integrity by Design and Pharma 4.0: Next-Gen Techniques to Approach GxP Systems, and FDA Compliance Across Pharmaceuticals, Medical Devices, Biologics, and Tobacco ...

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.

FDA Inspection Data Reveals a New Compliance Blind Spot for Medical Device Makers

Newly surfaced inspection data from the first months of the FDA's Quality Management System Regulation (QMSR) shows a tough new reality for life sciences teams: investigators are no longer looking at ...