Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product development, ...
A suite of guidance has been published by the Medicines and Healthcare products Regulatory Agency (MHRA). A suite of guidance ...
In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a ...
The federation of trusted research environments for genomics and health. Whilst trusted research environments are not yet ...
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The impact of regulation and AI on Europe’s medical device trial landscapeIn recent years, new regulation has been top-of-mind for medtech companies wishing to continue marketing their products in ...
The medical device sector faces significant changes, as both Donald Trump and Robert F. Kennedy Jr. have identified the FDA ...
The Centre is reclassifying 1,178 medical devices. This move is expected to enhance clarity and support the growth of India's ...
Stakeholders branded the MDR and IVDR rules “unreasonably complicated,” “terrible for EU patients and doctors” and “a mess.” ...
It specifies that by 2035, China expects to fully ensure the safety, efficacy and accessibility of drugs and medical devices, ...
New Delhi: In an attempt to bring regulatory uniformity in medical devices, the government plans to classify around 1,178 medical devices into four categories based on their risk approach under ...
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