Good Reprint Practices Revamped

By Casper E. Uldriks The Food and Drug Administration (FDA) issued a revised draft guidance document in February 2014 entitled, “Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practice… Read More
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The FDA Regulatory Challenges of Software Interoperability and Part 806

By Casper E. Uldriks The verification of design specifications and functional validation of software is predicated on its intended use with a particular device or as a “stand alone” device. The U.S. Food and Drug Administration (FDA) and the indu… Read More
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