This article presents a comparative analysis of the regulatory requirements for convenience kits and procedure packs in the US and EU, with an emphasis on classification criteria, labeling and unique ...

Recon: Supreme Court takes up ‘skinny labeling’ case; EC proposal would double EU regulators medtech staffs Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In ...

The Medicines and Medical Devices Safety Authority (Medsafe) is holding a consultation on plans to extend the abbreviated procedure for new medicine applications and certain change notifications. @ ...

Kick off the 2026 RAPS Twin Cities Chapter with an evening of learning, networking, and mentorship! The Speed Mentoring Event is designed to connect early-career regulatory professionals with ...

The 2025 edition of the Chinese Pharmacopoeia (CPh) of the People@s Republic of China includes systematic revisions and improvements across a range of entries. A key aim of the Chinese Pharmacopoeia ...

A study of routine good clinical practice (GCP) inspections between 2017 and 2023 found a declining number of Form 483s flagging violations at clinical trial sites and a very low number requiring ...

Device is intended for diagnosis, monitoring or treatment of a life-threatening or serious disease/condition. No generally acceptable alternative therapy exists. The risk from the disease or condition ...

Tweet Deck Once a premium tool, Twitter's purchase of Tweet Deck several years ago has opened it up to the masses, and with it a useful set of tools that should be of interest to anyone interested in ...

The dietary supplement industry in the US faces increasing class action risk driven by labeling, testing, and compliance claims. Courts continue to apply the reasonable consumer standard when ...

The US Food and Drug Administration (FDA) finalized a rule allowing Institutional Review Boards (IRBs) to waive or alter elements of informed consent for certain clinical trials that pose minimal risk ...

During the second meeting of the US Food and Drug Administration@s (FDA) Digital Health Advisory Committee (DHAC), members of the panel seemed shocked and, at times, lost for words when grappling with ...

This article discusses the impact of US state laws banning food ingredients. It examines two recently enacted state laws that require a warning or disclosure statement on the label, but do not ...