New Approach Methodologies, the EMA’s horizon scanning report

The Horizon scanning report published by the European Medicines Agency and the Heads of Medicines Agencies discusses the challenges and opportunities for the development and implementation of New Approach Methodologies (NAMs) to support regulatory decision-making

The FDA’s Advanced Manufacturing Technologies Designation Program

The Advanced Manufacturing Technologies Designation Program aims to accelerate the implementation of novel manufacturing technologies and the application of existing ones to new contexts of use. The FDA Guidance for Industry, published at the beginning of January 2025, describes the entire process of submitting a request for AMT designation and its contents