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