This event focuses on two key areas in MedTech: the distinction between wellness and regulated health technologies, and the integration of artificial intelligence throughout the product lifecycle.

This article discusses the impact of US state laws banning food ingredients. It examines two recently enacted state laws that require a warning or disclosure statement on the label, but do not ...

Medical device and pharmaceutical industry groups in the EU and US are urging significant changes to the EU@s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Europe@s ...

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) are running a survey to inform research priorities for the use of artificial intelligence in the development and ...

The US Food and Drug Administration has listed more than half a dozen research areas related to generic drug development and authorization that it plans to prioritize in FY 2026. The agency@s ...

The US Food and Drug Administration (FDA) will only conduct vital and mission critical activities amid a government shutdown that began Wednesday after Congress failed to reach a deal to fund the ...

During a public meeting on onshoring the production of drugs in the US on Tuesday, stakeholders called for improvements to the US Food and Drug Administration@s (FDA) recently launched PreCheck ...

WASHINGTON @ Denise Gavin, the director of the Office of Gene Therapy at the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), emphasized that clinical ...

The US Food and Drug Administration (FDA) has published three draft guidances on developing cell and gene therapies (CGT) to treat rare diseases, conducting postapproval CGT studies, and using the ...

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 ...

The 18 July 2025, deadline for Health Canada’s mandatory XML Product Monograph (PM) submissions has come and gone — but what has the transition revealed about industry readiness, process challenges, ...

The US Food and Drug Administration (FDA) has published scores of warning letters, most of them to companies for marketing and advertising compounded versions of glucagon-like Peptide-1 (GLP-1) ...