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 Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US Eli Lilly to buy gene-editing biotech Verve for up to $1.3 billion (STAT) Purdue opioid settlement ...

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 ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US HIV protection with just two shots a year: FDA approves Gilead drug (STAT) Gilead’s CEO on the ...

The Medical Device Coordination Group Document (MDCG) has published a question-and-answer document about running performance studies under the In Vitro Diagnostic Regulation (IVDR). IVDR requires ...

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 ...

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 ...

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, ...

The US Food and Drug Administration (FDA) has been steadily increasing the annual number of granted de novo classification requests in recent years and hit a record of 44 de novos granted during 2018.

Despite one’s best efforts, all plans are subject to change once they are in motion. The planning document is a living document that will need to be updated and adjusted to account for the unexpected.