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The US Food and Drug Administration (FDA) has issued a draft guidance outlining how manufacturers can ensure the data integrity of bioavailability (BA) and bioequivalence (BE) studies to support ...
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FDA Issues Draft Guidance on Data Integrity Considerations for Bioavailability and Bioequivalence Studies

The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...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

Keeping Track of Your Data — What You Need to Know about FDA’s Draft Guidance on Data Integrity for In Vivo Bioavailability and Bioequivalence Studies

Given data integrity issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on ...
GEN

Integrity Testing of Large-Size Filter Systems

The Integritest 4 Was Assessed Using Oversize Volumes to Determine Accuracy of Results Sterilizing-grade filters are designed to reproducibly remove microorganisms from the process stream producing a ...
Yahoo Finance

Filter Integrity Test Market Trends Analysis Report 2026-2033: Food & Beverage and Biopharma Demand, Automation Advances and GMP Compliance Requirements Bolster Growth

Dublin, April 17, 2026 (GLOBE NEWSWIRE)-- The "Filter Integrity Test Market Size, Share & Trends Analysis Report by Test Method (Forward Flow Test, Bubble Point Test, Pressure Hold Test, Water ...