The US Food and Drug Administration (FDA) has issued four warning letters to companies in China, India, and the US for various violations of good manufacturing practices (GMPs) related to the ...
The inability to conduct onsite inspections impeded investigators’ ability to uncover data integrity issues at manufacturing sites in drug warning letters in FY2021, underscoring the importance of ...
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issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on ...
The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...
Data integrity ensures the accuracy and reliability of data across its entire life cycle. Learn more about why data integrity is important. Clean, healthy data can be a major competitive advantage, ...
BioXcel Therapeutics faces regulatory challenges after the FDA found inconsistencies in one of its clinical trial sites, jeopardizing the supplementary approval of its drug, IGALMI. BioXcel's ...
Learn the definition of data quality and discover best practices for maintaining accurate and reliable data. Data quality refers to the reliability, accuracy, consistency, and validity of your data.
In a recent Hayes Management Consulting blog, Leala M. Williams explains if Biometric identification is the answer to patient data integrity issues. Long gone are the days of standalone demographic ...
The News Leaders Association will not be releasing the results of its 2021 diversity survey due to problems with the collected demographic information, the organization announced Friday. Those issues ...
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