Health Care Law News and Insights

On August 4, 2023, the FDA issued a new Guidance to the pharmaceutical industry relating to large molecule drugs left unaddressed in its earlier nitrosamine Guidance publications. (Access the complete Guidance or the abbreviated version.) Reacting to considerable input from the pharmaceutical industry, both brand and generic, following the agency's Federal Register...

Read More

Health care providers furnishing dementia care should take note of a new payment model called Guiding an Improved Dementia Experience (GUIDE), which was announced by the Centers for Medicare & Medicaid Services (CMS) on July 31, 2023. GUIDE is designed to improve dementia care, reduce strain on unpaid caregivers, and...

Read More

A recent decision by the Supreme Court clarified the required intent for a defendant to be held liable under the False Claims Act. According to the Court, the FCA's scienter requirement refers to a defendant's knowledge and subjective beliefs – not what an objectively reasonable person might have known or believed. This...

Read More