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 ...

Over the past decade, the global landscape of medical device quality management has undergone a significant transformation. While ISO 13485:2016 provides a common foundation, regional adaptations ...

Medical device manufacturers are required to undertake a range of postmarket surveillance (PMS) activities to comply with regulatory requirements to ensure the safety and performance of their devices ...

The use of real-world data (RWD) to help design clinical trials is nothing new but increasingly it is being used early in the process to boost trial diversity and inclusion.

The International Council for Harmonisation (ICH) has endorsed the eCTD @ the electronic common technical document @ as the message standard for electronic submissions. This article presents an ...

Team-NB has shared proposals for how to stop “lengthy debates” between manufacturers and notified bodies about the applicability of a rule about the need for clinical data on medical devices.

Welcome to another installment of This Week at FDA, your weekly source for updates@big and small@on FDA, drug, and medical device regulation and what we@re reading from around the web. This week ...

PITTSBURGH — Is it worth agreeing to an early orientation meeting with the US Food and Drug Administration (FDA) about your medical device software? Alex Cadotte, vice president of Digital Health, AI, ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US Inside FDA, career staffers describe how political pressure is influencing their work (STAT) The long ...

The US Food and Drug Administration (FDA) on Wednesday finalized guidance recommending that drugmakers only use placebos in cancer clinical trials in select circumstances due to ethical concerns that ...

Artificial intelligence (AI) is already writing code, generating requirements, and suggesting test cases — but how do RA/QA teams maintain oversight when these tools operate inside regulated workflows ...

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 ...