This event will share an update to the AI landscape, including challenges to AI development, standards & regulations to address these challenges, and a deeper dive into AI risk and AI cybersecurity.

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

The US Food and Drug Administration (FDA) has finalized guidance to assist sponsors in requesting meetings with the agency following the receipt of a warning letter. Requesting these meetings was a ...

Head of Education Programs Location: Rockville, MD (Hybrid or Remote) Key Skills: Program planning, budgeting, managing, and implementing Experience: 4-6 years of experience Reports to: Senior VP of ...

The US Food and Drug Administration (FDA) and National Institutes of Health (NIH) have jointly published a glossary of real-world evidence/real-world data (RWD/RWE) terms intended to improve ...

Learning Objectives At the conclusion of this workshop, participants should: Be familiar with various types of biologic products and their structural/functional characteristics Understand development ...

Explore why styles guides and lexicons are indispensable for document quality and learn how to adapt them as a standard for every document that the team writes.

Gene therapies have the potential to revolutionize disease treatment by addressing underlying genetic disorders, offering a beacon of hope in healthcare. However, their complexity and the rapidly ...

To ease the process of finding drug and medical device regulators in Europe, Focus has updated its list of the website (s) for each country’s ministry of health and regulatory authority. The list is ...

Computer software used in healthcare device applications developed for demographic data gathering, physical examinations or therapies are increasingly part of the regulatory landscape. This article, ...

As novel therapy development increases, regulatory standards evolve and technology plays an increasingly more important role in the management of regulatory information, regulatory operations ...

European Union/European Commission The European Union recently published two new medical device regulations with a proliferation of new guidance documents with which quality and regulatory ...