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 ...

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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 US Food and Drug Administration (FDA) will only conduct vital and mission critical activities amid a government shutdown that began Wednesday after Congress failed to reach a deal to fund the ...

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 ...

Overall, consumers understood the risk information better when they saw the same risk information in audio format with a verbatim text accompaniment. However, they did not find that contrasting ...

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 @ ...

This article provides an overview of critical regulatory requirements to be considered for Association of Southeast Nations (ASEAN) pharmaceutical markets and covers certificates of pharmaceutical ...

President Donald Trump@s order requiring the removal of 10 regulations, rules, or guidances for each new one issued will put administrative pressure the US Food and Drug Administration (FDA) and other ...

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 ...