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

Practices: Health Care, FDA Regulatory, Digital Health, Data, Privacy & Cybersecurity, Privacy & Cybersecurity Compliance and Counseling, Technology, Media & Telecommunications

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.

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