New FDA Draft Guidance for Chemical Analysis
In this podcast our host Brandon Miller from Regulatory Compliance Associates is joined by Raymond Colton, Director of E&L...
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Testing of High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
Contamination from ethylene glycol and diethylene glycol in liquid formulation poses a high risk to patient safety....
2023 Spring AAMI Standards Week Update
In this podcast from Nelson Labs, business leaders who recently returned from the AAMI standards week meetings...
Skin Care Products Understanding Clinical Testing Options
Skin-care products have become an essential part of the cosmetic and personal-care industry. Whether you are dealing...
Preservative Effectiveness Testing – Calling Attention to Burkholderia SPP
Controlling the growth of microbes within non-sterile formulations is critical for ensuring product safety and meeting regulatory...
Extractables and leachables testing of a combination device: testing in between regulations for pharmaceutical products and medical devices
Extractables and leachables (E&L) testing of combination devices requires a specific study setup that differentiates from a...
After E&L Updates to the Standard for Toxicological Risk Assessment 10993-17
The use of extractables and leachables (E&L) chemistry testing has become integral and often essential in the...
FDA Feedback Reguarding Chemistry for Toxicological Risk Assessment – How to Make Sure FDA will Accept Your Protocol
Understanding the latest trends in FDA feedback regarding extractables chemistry testing is crucial for ensuring compliance and...
Establishing the Proper Alcohol/Water Proportion for Simulating Solvents Used in Controlled Extraction Studies
The purpose of this whitepaper is to provide comprehensive guidance on determining the appropriate alcohol/water proportion for...
How Chemical Characterization Can Supplement and Support Biocompatibility Testing
There’s a lot of urban legend when it comes to using gamma radiation to reduce pathogens in...