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 ...

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 ...

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 ...

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, ...

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 ...

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 ...

The US Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) are seeking public input on regulations, rules, or guidelines that should be eliminated under ...

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 ...