You need to enable JavaScript to run this app. Canada's Regulatory & Quality Medtech Conference 2025 In-Person Partner Events ...

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 ...

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

Pharmaceutical industry groups in the EU are requesting more information on how to conduct decentralized trials to encourage their adoption. They also emphasized the need for clearer guidelines on ...

A robust 510(k) plan is crucial for a smooth and speedy route to market. This webinar gives you everything you need to know to become a 510(k) master.

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

The International Council for Harmonisation (ICH) has recently released two draft guidelines for public consultation. One draft guideline focuses on assessing new drugs for pregnant populations in ...

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

You need to enable JavaScript to run this app. RAPS United Kingdom LNG Town Hall Meeting. Advanced therapies/cell and gene therapy APIs Biologics/ biosimilars ...

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

The US Food and Drug Administration (FDA) has issued warning letters to a drugmaker and a diagnostics company for failing to meet its current good manufacturing practices (cGMP) requirements. The ...

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