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 ...

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.

In a scathing letter resignation letter, Peter Marks, the US Food and Drug Administration@s (FDA) top biologics regulator, said he is leaving the agency due to Health and Human Services (HHS) ...

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 @ While the US has more recently been viewed as the market of choice for medtech product launches, recent political and economic developments have led companies to reconsider which markets to ...

This course provides an overview of GLP regulations as they are applied and interpreted by the FDA, EPA and the Organization for Economic Cooperation and Development.

Australia@s Therapeutic Goods Administration (TGA) is running a consultation into plans to adopt three international scientific guidelines.

The Toolbox brings together a full range of valuable resources, gives you a sense for the kinds of questions you will be tested on and clarifies how the exam is structured.

The US Food and Drug Administration (FDA) on Tuesday announced a new framework for licensing COVID-19 vaccine boosters that would move away from the agency@s more universal approach to boosters to ...