In April 2010 the U.S. Food and Drug Administration (FDA) sent a letter to companies and a wide range of other key stakeholders detailing the agency’s concern over cargo and warehouse thefts of FDA-regulated products. (more…)
Archive for the ‘FDA’ Category
Mar 21st
Checking in on FDA 21 CFR Part 11 Compliance – Our Survey Results
FDA 21 CFR Part 11 compliance has been a hot topic over the last year. There are still a lot of questions around what it means to comply and the best way to become compliant, but as the FDA cracks down, most agree that it is essential that their label design, approval, management and production processes are secure. (more…)
Jan 5th
2010 in Review – Counterfeits, Compliance, and the Path Forward
It is impossible to talk about major identification and labeling events in 2010 from a pharmaceutical, chemical or medical device perspective, without discussing compliance and the battle to combat counterfeits. (more…)
Dec 7th
Why are Some Pharmaceutical Labels Still Putting Patient Safety at Risk?
When the FDA introduced SPL (structured product labeling), the idea was to help inform consumers and improve patient safety. This regulation requires manufacturers to submit prescribing and product information (i.e., the package insert or label) using standardized medical terminology in a readable, accessible format. (more…)
Nov 24th
Are you compliant with FDA labeling legislations?
One of the top areas where organizations fall short when audited for FDA compliance is not documenting their standard operating procedures for labeling.
What are you doing to make sure you have the required documentation? (more…)
Aug 3rd
Understanding ePedigree and Serialization
‘ePedigree’ and ‘Serialization’ have become hot topics in the world of pharmaceutical and medical device tracking. But how many of us really understand the difference between the two? (more…)
