Regulatory intelligence

Medical writing professionals play a pivotal role in preparing regulatory submission dossiers. Through years of experience, our experts have developed effective strategies to streamline the submission process and implement best practices that ensure high-quality, compliant documentation.

Mental health disorders affect millions, and with increasing diagnoses, the demand for new, accessible treatments is growing. In this whitepaper, we examine how SaMD, particularly through digital therapeutics, is providing new solutions for mental health management.

Episode 1: Warning letters and recalls

Hear our Medical Device experts explore FDA warning letters, recalls and the benefits of early clinical and regulatory engagement in this informative podcast. Tune in for practical information to avoid compliance pitfalls and stay ahead of the regulatory curve. 

This briefing document describes external control arms and provides concise information on the FDA’s regulatory precedent regarding their acceptable use. It also summarizes the most salient recommendations for sponsors from the FDA’s Draft Guidance for Industry on Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.

This whitepaper discusses the varying regulatory and legal jurisdictions across countries for decentralised clinical trials, including a summary of the recent FDA draft guidance on the use of digital health technology.

In this white paper, ICON’s experts outline potential regulatory strategies and interaction plans for sponsors in China as a guide for marketing authorisation applications in the centralised procedure to the EMA, which allows the marketing authorisation holder to market a drug product in all European Union (EU) Member States, in addition, specific countries in European Economic Area (EEA), with a potential patient pool of approximately 500 million people. 

The European Union Clinical Trial Regulation 536/2014 (EU CTR) introduces fundamental changes for interventional clinical trial submissions and approvals in all 30 countries of the European Union and the European Economic Area. The EU CTR has established a harmonised approach for clinical trial applications, assessment and reporting with consistent rules. Review our insights to understand the impact and strategic considerations for sponsors.

For sponsors preparing to meet short deadlines for PLS submission, this whitepaper outlines considerations such as creating compliant templates, endpoint consistency and inclusion, and health literacy.

Sponsors preparing to share their clinical documents can incorporate best practices and implementation recommendations presented in this whitepaper, including considerations for planning and basic data anonymisation strategies for protecting patient privacy while balancing data utility.

Ensuring regulatory compliance with the PSMF

It is essential that those who hold Marketing Authorisations (MA) within the European Economic Area have an established Pharmacovigilance System Master File (PSMF), which should be ready at the time of submission of all new applications for MAs. This whitepaper assesses the effectiveness of a global PSMF and its benefits to study personnel.

What companies must consider when developing an asset and the importance of regulatory strategy

Gain insight into the common questions small and emerging biotech companies face, and the importance of early engagement and regulatory affairs when developing an asset and considering a drug development partner.

Stay current on country, regional and global regulatory changes with ICON’s monthly Global Regulatory Intelligence Newsletter. It will keep you up to date with global regulatory changes that could impact your product.

Our experts review, interpret and summarise the latest regulatory developments so that you can spend more time taking your product to market.