Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

A notified body trade group has called for the European Commission to extend its timelines for adopting planned changes to the medtech regulations.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

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 ...

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 ...

John Farley has been appointed director of the Office of Infectious Diseases (OID) in the Center for Drug Evaluation and Research’s Office of New Drugs (OND). He had been acting director of OID since ...

The Department of Government Efficiency (DOGE) this week claimed it had canceled 30 leases for US Food and Drug Administration (FDA) facilities nationwide, including a facility in St. Louis, MO, which ...

While FDA experience is highly valued in the private industry, transitioning from the agency to private-sector employment requires new skills and a shift in mindset. This article provides resources ...

This two-part article covers the specific requirements for placing foods for special medical purposes (FSMPs) on the market in major jurisdictions @ EU, UK, US, China, and other regions of the world @ ...

Where to Start Endpoint Analysis Information Blocking Armed with the needed endpoint information and the tools to find it, the next step is to understand how to “block” the information so that it is ...

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 ...

This article provides an overview of FDA@s medical device Unique Device Identification System Final Rule1 and explains why including UDIs in health information and in device recalls can improve ...