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

Makary and Prasad recently signaled their interest in bringing products more quickly to market through more streamlined pathways in a roundtable meeting with stakeholders discussing cell and gene ...

Welcome to another installment of This Week at FDA, your weekly source for updates@big and small@on FDA, drug, and medical device regulation and what we@re reading from around the web. This week, FDA ...

Medtech Exclusive: Commons Clinic raises $26M Series B to offer preventive testing (Endpoints) The $7 Billion Nicotine-Pouch Market’s Next Target? Women (Bloomberg) Medtronic recalls ventilators ...

As an example of how AI tools could be used to regulate in real time, Walsh said that the fastest way they've been able to output studies from FDA's Sentinel Initiative, which tracks safety reports ...

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 ...

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 ...

Reflecting changes in testing technology, a new and immediately effective guidance from the US Food and Drug Administration (FDA) updates the agency’s approach to retention of reserve samples for ...

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, ...

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 ...