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Étiqueté : Labelling

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Public consultation – FDA Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Cell and Gene Therapy Catapult – Regulatory Round-up – January 2023)

Title :  Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry End date :14 March 2023 Category: Draft guidance See all of Catapult’s Regulatory...

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Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells (Cell and Gene Therapy Catapult – Regulatory Round-up – October 2022)

The guideline was first published on the 26th of October 2022. It defines the information to be included in the summary of products characteristics (SmPC), labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified...