ePT--the Electronic Newsletter of Pharmaceutical Technology
European Medicines Agency Issues Drug Review Update; And More
The European Medicines Agency's Committee for Medical Products for Human Use issued an update on drug reviews by the agency on July 23, 2010. Included in the update is information on Avandia (rosiglitazone), generic drugs, pediatric indications, rotavirus vaccines, and more.
The US Food and Drug Administration issued a warning regarding certain Advair Diskus inhalers that were stolen from a distribution warehouse in 2009 and now have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be guaranteed and the inhalers should not be used, said the agency in its announcement.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.