In December 2021, FDA issued draft guidance, Digital Health Technologies (DHTs) for Remote Data Acquisition in Clinical Investigations, which provides guidance for clinical trial sponsors, investigators and other interested...more
The federal government continues to weigh in on artificial intelligence, algorithmic fairness and related issues. In the latest artificial intelligence briefing, we analyze recent events in Washington, D.C., and also track...more
The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued a total of six letters in 2021 — four Untitled Letters and two Warning Letters — to pharmaceutical or biologics companies for promotional...more
On November 17, 2021, the Drug Enforcement Administration (DEA) issued an Advanced Notice of Proposed Rulemaking (ANPR) to seek public input from state regulatory authorities, national and professional associations, industry,...more