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 ...

2026 Categories and Topics Session Type Preconference Workshop: a one-day workshop that occurs the day before the main conference. These workshops are designed for attendees to take an extensive, ...

Stakeholders say they want lower regulatory hurdles for cell and gene therapy (CGT) products, including streamlined pathways. Some researchers said updates to the US Food and Drug Administration@s ...

In an email to agency staff reviewed by Focus, US Food and Drug Administration (FDA) Commissioner Martin Makary, said he wants to consolidate many of the FDA’s operations to streamline its work. He ...

WASHINGTON – Marty Makary, commissioner of the US Food and Drug Administration (FDA), said he wants the agency to become nimbler in the next five years to adapt to the fast pace of medical innovation.

This year, an unspecified number of drug developers will be eligible to take part in a pilot of the new US Food and Drug Administration (FDA) Commissioner’s National Priority Voucher (CNPV) program, ...