The International Council for Harmonization (ICH) works to make global trade in the pharmaceutical industry easier. According to a recent article, the ICH “issued in December of 2017 a draft guidance aimed at more uniformity in rules on the quality of medicines...
Questions about social media influencers and dietary supplement claims? Clarifications on FTC regulations covering the disclosure of material connection, substantiation and liability are essential for dietary supplement manufacturers utilizing online promotions. Diana...
Combination Products Approval Operations with Art Faulkner Art Faulkner, VP, Regulatory CMC at TG Therapeutics, is one of many distinguished presenters at this year’s 4th Annual Regulatory Affairs CMC: Chemistry, Manufacturing, and Controls Conference. His...
Beep…Boop…Bop Redesigning the Sounds of Medical Devices Human Factors and Usability professionals have the unique understanding of how healthcare professionals can and do use medical products in a real-world setting. The art and science of developing medical devices...
Working with Laboratory Benefit Managers: Tips & Best Practices Mitchell I. Burken, M.D.Associate Medical DirectorGeneticseviCore Whether you’re in the early stages of working with Laboratory Benefit Managers or are have more experience, understanding how...
