In Law360, Life Sciences Attorneys Address Proposed FDA Drug Software Rules

In The News
December 11, 2018

Life sciences partners Albert Cacozza and Kellie Combs and associates Joshua Oyster and Rebecca Williams (all of Washington, D.C.) authored a Dec. 10 article published in Law360 on the U.S. Food and Drug Administration’s proposed rules for regulating prescription drug-use-related software.

The authors examine the proposed FDA framework including relevance of existing digital health device policies, when information may be included in FDA-required labeling, promotional labeling and associated obligations, and practical implications.