Author Archives: Patti Zettler

The Logical Outgrowth Doctrine and FDA’s Intended Use Revisions

by Patti Zettler — Tuesday, July 18, 2017@pzettler

Cross-Posted on Objective Intent In January FDA published a controversial revision to its regulations defining a product’s “intended use” that, among other things, has raised an interesting logical outgrowth question. “Intended use” is an important concept in FDA law because a product’s intended use—judged by the “objective intent of the persons legally responsible for the [product’s] labeling”—can […]

FDA Advisory Committees and Industry-Funded Patient Advocacy

by Patti Zettler — Friday, June 23, 2017@pzettler

Cross-posted on Objective Intent and Stanford’s Law and the Biosciences Blog. Industry funding of patient advocacy organizations recently has received attention from media and researchers.  For example, one 2017 study in the New England Journal of Medicine found that over 80% of patient advocacy organizations with annual revenues of at least $7.5 million reported receiving industry […]