Faegre Drinker Biddle & Reath

Faegre Drinker Biddle & Reath LLP is an international firm providing a range of services including litigation, regulation, and business services to companies of all sizes.

On March 15, the United States Food & Drug Administration published a white paper entitled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” FDA announced the paper by sharing a short letter from Commissioner Califf, where he reaffirmed the Agency’s commitment to “promoting the responsible and ethical development, deployment,

Take a quick dive into the exciting world of ERISA with Faegre Drinker benefits and executive compensation attorneys Fred Reish and Brad Campbell. In this quick-hit series of updates, Fred and Brad offer a high-level view of current trends and recent ERISA developments. See the newest episode, Automatic Portability of Safe Harbor IRAs and the

Our partner Nolan Tully recently co-authored a research report, “Data-Driven Pre-Claim Programs Bend The LTCI Claims Cost Curve,” with Assured Allies. In the report the authors discuss an evidence-based program to reduce aging-related disability and help long-term care insurance (LTCI) policyholders remain independent longer.
In the report, Nolan along with Assured Allies’

Most in-house counsel periodically encounter branding questions — and the business team wants answers … yesterday! To give you a head start, this article discusses key branding questions that companies frequently face and provides a roadmap for addressing them. Can I trademark/patent/copyright this name? Let’s find out! For starters, let’s clarify. This common intellectual property

The U.S. Environmental Protection Agency (EPA) recently released their long-awaited final rule regulating ethylene oxide (EtO) emissions from commercial sterilizers. The final rule comes after five years of development, over 1,000 comments, and with estimated compliance costs for industry of up to $900 million. The final rule differs significantly from EPA’s initial proposed rule. See initial proposal

As it is often said, “the only constant in the world is constant change,” so it is important for health plan fiduciaries to periodically review the fundamentals for consistency and compliance to avoid risk and costly mistakes.  Below is a Health Plan Fiduciary Checklist with five (5) actions that health plan fiduciaries can take to

Federal preemption can be a very powerful defense.  For example, claims concerning Class III medical devices requiring pre-market approval are generally preempted by the Medical Device Amendments of 1976, 21 U.S.C. § 360c, et seq. (“MDA”).  In Regwan v. Abbott Laboratories, Case No. B319606, 2023 WL 8818748 (Cal. App. 2d Dec. 21, 2023), the California