RAPS

FDA turns attention to data integrity lapses at testing sites in new guidance

The US Food and Drug Administration (FDA) has issued a draft guidance outlining how manufacturers can ensure the data integrity of bioavailability (BA) and bioequivalence (BE) studies to support ...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

FDA Warns Chinese API Maker for Data Integrity Issues

The US Food and Drug Administration (FDA) on Monday released a warning letter sent to active pharmaceutical ingredient (API) maker Qinhuangdao Zizhu Pharmaceutical for data integrity issues uncovered ...
JD Supra

Complete Response Letter, Warning Letter and Shareholder Lawsuit Follow FDA Data Integrity Findings

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) ...
BioSpace

FDA alleges ‘manipulated’ data supported approval of Amgen’s autoimmune drug

The FDA has renewed calls for Amgen’s Tavneos to be pulled from the market, saying it has discovered new evidence that study ...
JD Supra

FDA Debuts a New Communications and Compliance Tool for Device Data Integrity Concerns

Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to medical devices. Over a year ago, FDA’s device center, the ...

Clinical Systems Architect Enables FDA Approval Of Cancer Drugs Reaching Millions Of Patients

Ramakrishna Sesham, Senior Manager at Astellas Pharma, develops enterprise data governance frameworks that reduce FDA ...
SDxCentral

DvSum Selected by FDA as Data Intelligence Platform to Bring Life-Saving Drugs to Market with Greater Speed and Efficiency

SUNNYVALE, Calif.--(BUSINESS WIRE)--#DvSum--DvSum, a leader in data intelligence management, is pleased to announce its partnership with Booz Allen Hamilton and the U.S. Food and Drug Administration ...