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 ...

Editor’s note: This article was updated on 18 June 2025 to clarify aspects of Prasad’s new role. In an email to US Food and Drug Administration (FDA) staff on Wednesday, FDA Commissioner Martin Makary ...

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 ...

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, ...

WASHINGTON – Top executives at the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) say they are trying to be pragmatic about their resources and want to learn from other regulatory ...

The mission and operations of Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT) will be subject to systematic review and possibly curtailed, Argentina’s government says.

The US Food and Drug Administration (FDA) has finalized guidance detailing the information that sponsors must submit in a pre-submission facility correspondence (PFC) for priority review of ...

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.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US Senators Propose Ban on Drug Advertising to Consumers (The Wall Street Journal) Sarepta reports ...

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has shared a draft update to its bioequivalence guideline for consultation, proposing changes to align its position with ...