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EMA guideline on investigational ATMPs

The guideline adopted by EMA’s CHMP Committee on 20 January 2025 will come into force on 1 July. It discusses in detail all the different aspects to be considered during the development of an investigational advanced therapy medicinal product, both in exploratory and confirmatory studies, in order to prepare a submission dossier adequate to support application for marketing authorisation

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