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Risk Management › Marketing › Health Care Providers

Baker Donelson

EKRA's Application to Marketing Arrangements: Laboratories and Other Providers

Baker Donelson on

The Ninth Circuit recently affirmed two decisions that provide additional guidance regarding how arrangements with marketing agents implicate and violate the Eliminating Kickbacks in Recovery Act, 18 U.S.C. § 220(a)(EKRA)....more

Loeb & Loeb LLP

In Our "Wellness Retreat" Era. But First, the Paperwork.

Loeb & Loeb LLP on

These days, the explosive growth of the wellness industry—fueled by increased consumer interest in healthy lifestyle choices—presents a prime opportunity for brands to showcase their offerings through “wellness retreats” with...more

Sheppard Mullin Richter & Hampton LLP

Reminder: FDA Does, In Fact, Review DOF

Sheppard Mullin Richter & Hampton LLP on

When was the last time you thought about “data on file” (“DOF”)? Probably not recently, but last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted an untitled letter (the...more

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