EMA Guideline on Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials
Medicinal Products, Clinical Trials, European Medicines Agency Elisabethann Wright Medicinal Products, Clinical Trials, European Medicines Agency Elisabethann Wright

EMA Guideline on Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials

The European Medicines Agency (EMA) has introduced a draft new guideline on the inclusion of pregnant and breastfeeding women in clinical trials. The goal is to ensure that developers of clinical trials generate robust clinical data in relation to pregnant and breastfeeding women, so that these individuals and their healthcare providers can make informed, evidence-based decisions when using medicines.

Read More
The European Court of Justice clarifies different definitions of a medicinal product and a medical device
European Court of Justice, Medicinal Products, Medical Devices Elisabethann Wright European Court of Justice, Medicinal Products, Medical Devices Elisabethann Wright

The European Court of Justice clarifies different definitions of a medicinal product and a medical device

In a recent judgment in response to a request for a preliminary ruling (CURIA - List of results) the European Court of Justice (ECJ) provided guidance concerning how to distinguish medicinal products from medical devices.

Read More