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.

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.

The presentation will focus on the promise if gene therapies for treating genetic diseases and the complex regulatory challenges they face due to evolving science and varied global standards.

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, ...

February articles tackled the evolving role of regulatory operations professionals and the need for building interorganizational relationships.

This article discusses how medical device guidance documents, regulations, standards and requirements are presented in increasing amounts and how regulatory professionals can access, assess, manage ...