Other content tagged: EMA
Expert feedback wanted: new EMA guideline drafted for public consultation
The European Medicines Agency (EMA) released a draft guideline for public consultation on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations. The guideline covers devices that are necessary for the administration, dosing or use of the medicine. They can be integral, co-packaged or referred to in the product information of the medicine but obtained separately. It is intended that this guideline will increase transparency and consistency of information in regulatory…
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EMA drafts guideline for medicinal products containing genetically modified cells – Feedback wanted!
The European Medicines Agency has released a draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells for public consultation. This guideline aims at defining scientific principles and shall provide guidance for the development and evaluation of medicinal products containing genetically modified cells intended for use in humans and presented for marketing authorisation. The guideline focuses on the quality, nonclinical aspects and safety and efficacy requirements of genetically modified cells developed as medicinal products. Please…
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Human milk banking
A guest article by Professor Jean-Charles Picaud, President of European Milk Bank Association (EMBA) Health benefits of breastfeeding are well-known in healthy term infants. These benefits are even greater in preterm infants as human milk (HM) feeding reduces the risk of complications associated with prematurity, such as digestive intolerance, necrotising enterocolitis, sepsis, retinopathy of prematurity (ROP) and bronchopulmonary dysplasia. As these benefits specifically present in preterm infants are dose-dependent, babies should receive as…
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