explore how regulatory affairs professionals can proactively support strategic supply chain reconfiguration to mitigate tariff impact—without compromising compliance, ...

Show the world that you have the foundational knowledge regulatory affairs professionals need. The new Foundation in Regulatory Affairs (FRA) assessment-based certificate is designed to help you build ...

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

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

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Regulatory intelligence/policy 81% Regulatory writing/documentation 69% Product development 59% Product lifecycle 58% Clinical trials 55% Compliance 50% Professional development/training 47% Risk ...

BRUSSELS @ While structured dialogs with notified bodies don@t offer the same opportunities for feedback to medtech companies as presubmission meetings with the US Food and Drug Administration (FDA), ...

Welcome to another installment of This Week at FDA, your weekly source for updates@big and small@on FDA, drug, and medical device regulation and what we@re reading from around the web. This Week, the ...

The US Food and Drug Administration (FDA) sent warning letters throughout April to three companies for current good manufacturing practice (cGMP) violations for finished pharmaceuticals, including ...

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 UK Medicines and Healthcare products Regulatory Agency (MHRA) is holding a consultation into the use of external control arms based on real-world data (RWD) to support regulatory decisions.

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 ...