The European Commission has proposed targeted reforms aimed at simplifying rules for medical devices. The proposed reforms are part of a package of measures put forth by the Commission this week to ...
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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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 ...
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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 @ ...
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 article reviews the changes in China@s national food safety control system and update on national food safety standard system and describes the country@s unique regulations and requirements for ...
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 ...
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 ...
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