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

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.

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 ...

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 ...

Woodcock’s tenure at FDA began at the Center for Biologics Evaluation and Research (CBER) in 1986, where she held various division and office director-level roles before being promoted to CDER ...

A newly finalized guidance from the US Food and Drug Administration (FDA) smooths the path for manufacturers of devices and device-led combination products that stand to improve the safety of existing ...

Expanded access, also referred to as compassionate use, is a vital pathway for patients with life-threatening diseases to gain early access to unapproved investigational medical devices. This article ...

Unit-dose repackaged oral solid medications will generally not be subject to US Food and Drug Administration (FDA) action regarding nonconformance with expiration date provisions, so long as certain ...