This article provides a comprehensive overview of recent changes in US trade policy. It highlights key developments such as new global tariffs and bilateral trade agreements, sector- and ...

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic (s) and/or demonstrated competence related to the topic (s). Higher-level concepts are ...

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

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

The US Food and Drug Administration (FDA) recently posted four warning letters to pharmaceutical manufacturers in the US, Canada, and China for violations of current good manufacturing practices ...

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 ...

Alongside the request for comments, HHS issued a separate notice identifying four documents for immediate recission, including a COVID-19 era notice on scarce or threatened materials subject to ...

The US Food and Drug Administration (FDA) on Wednesday finalized two guidances on developing drugs to treat community-acquired or hospital-acquired and ventilator-associated bacterial pneumonia. Both ...

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 regulatory environment of FSMPs in the EU has been previously well-described by Bushell. 61 The authors show the definition of FSMPS is broad enough to encompass a wide variety of FSMPs necessary ...

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 @ ...

Thousands of workers at the US Food and Drug Administration (FDA) were abruptly fired on 1 April as part of President Donald Trump@s effort to reduce the size of the federal government. Many agency ...