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

A comprehensive reference for easily accessing information regarding medical device regulations across different regions worldwide.

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Uruguay@s top health official, Cristina Lustemberg, has sought dialogue with opposition-party lawmakers in an attempt to push forward a project to create a national medicines agency, which Uruguay ...

The US Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) are seeking public input on regulations, rules, or guidelines that should be eliminated under ...

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The International Council for Harmonisation (ICH) on Wednesday announced it will develop four new guidelines addressing real-world evidence, comparative efficacy studies, rare disease drug development ...

BRUSSELS @ The European database on medical devices (EUDAMED) may feel burdensome to medical device manufacturers, but an expert says it can also be an opportunity for companies to represent their ...

The Trump Administration is seeking $6.8 billion to fund the US Food and Drug Administration (FDA) in FY 2026 @ an 11.5 percent cut from its current budget authority @ with the agency looking to ...

The US Food and Drug Administration (FDA) is exploring the possibility of changing the fee structure of the Prescription Drug User Fee Act program (PDUFA) to rebuild trust in the agency, said Grace ...

Leveraging artificial intelligence in product reviews and postmarketing surveillance is a top policy priority for the US Food and Drug Administration (FDA), FDA Commissioner Martin Makary said at the ...