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FDA’s New Guidance on Nitrosamine and Nitrosamine- Drug Substance Related Impurities and Recommended Acceptable Intake Limits
The FDA has recently published a Recommended Acceptable Limit guidance document for nitrosamine impurities in drug products....
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Navigating the Complex World of PFAS Regulation for Medical Devices
Per- and poly-fluoroalkyl substances (PFAS) are a group of fluorinated compounds characterized by carbon-fluorine bonds. While some...
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Clinical trial monitoring
Monitoring Clinical trial monitoring is a constantly evolving field, now encompassing various approaches that work together to...
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An important downside to eSTAR
If you are keeping abreast of FDA’s medical device efforts, then you know that as of October...
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Creating a Conference Presentation: All You Need is an Hourglass
Creating an easy to follow, interesting, conference presentation is always the goal of conference attendees, but quite...
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Expanding MR Conditional labeling options using new laboratory equipment
We recently added new equipment to our MRI safety evaluations laboratory that can be used to provide...
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On the Record: Compliance with 21 CFR Part 11 in Clinical Trials
What is 21 CFR Part 11? The United States Code of Federal Regulations (CFR) includes regulations for...
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Radiopacity evaluation of a medical device
During the summer of 2022, we expanded into a new space to better serve our customers. This...
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Scientific writers and clinical evaluation reports (CERs)
Scientific writers can help you with your clinical evaluation needs. Clinical evaluation is an ongoing requirement for...
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An Introduction to Implementing CDISC Study Data Standards
Importance of Study Data Standards Exchanging data globally has become much simpler as information technologies develop. However,...
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ISO 10993-17 Revision
The new version of ISO 10993-17 is expected to be published very soon. This is a major...
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Effective management of your clinical trial budget
Successfully executing a clinical trial is a large undertaking that requires strategic planning and cooperation. Even if...
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