By Rishika Sadam May 29 (Reuters) - The U.S. Food and Drug Administration has flagged data integrity, manufacturing and ...

The US FDA has proposed withdrawing Amgen's Tavneos after finding alleged clinical trial data manipulation. Regulators also report that untrue statements were made in the approval process for the drug ...

The US Food and Drug Administration (FDA) has issued a draft guidance outlining how manufacturers can ensure the data integrity of bioavailability (BA) and bioequivalence (BE) studies to support ...

Dabur India has come under intense regulatory scrutiny after investigators from the U.S. Food and Drug Administration (USFDA) documented a series of significant quality, data ...

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 FDA and EMA increasingly expect to see the patient voice incorporated into drug development. In-trial patient interviews ...

BETHESDA, MD – Data integrity issues were the primary reason for the US Food and Drug Administration’s (FDA) delay in approving abbreviated new drug applications (ANDAs) past their review goal date, ...

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

The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...

Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration (FDA) ...

CFR Part 11 compliance defines how electronic records and electronic signatures can be used in FDA-regulated clinical trials and research environments. The regulation outlines requirements for system ...

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 ...