Drugs

FDA Recognizes All EU States Under MRA

FDA says it has completed “capability assessments” of the 28 European Union (EU) member states under the FDA/EU Mutual Recognition Agreement (MRA). The completed assessments allow FDA to rely on the drug inspections conducted by these foreign regulatory authorities. The 28 regulatory authorities found to be capable are those located in: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.

“We see evidence that the MRA is creating important efficiencies,” the agency says in an online post. “Before the MRA was implemented, the EU and the FDA sometimes would inspect the same facilities in the same year, even if the facility had a strong record of compliance. We expect the MRA will reduce this duplication, allowing the FDA and the EU to reallocate their resources towards inspection of drug manufacturing facilities that have potentially higher public health risks.”

Additionally, FDA says that information from EU inspection reports will help it with deciding which sites to inspect under the agency’s risk-based site selection model, “ensuring that our resources are allocated in the most efficient and appropriate manner, while considering risks in the product and manufacturing process that could cause potential harm to patients. Prioritizing inspections in this way will allow us to identify drug supply issues more quickly and to prevent poor quality drugs from entering our drug supply chain from higher risk facilities.”

Currently, the MRA is being applied to surveillance inspections conducted only within each regulatory authority’s respective borders. “However, the U.S. and the EU have the option of relying on inspection reports for manufacturing facilities located outside each other’s territories,” the post says. “And while the MRA is now limited to inspections of facilities manufacturing human drug products, we're evaluating the possibility of including other regulated products, such as veterinary products, human vaccines, and plasma-derived drugs, in the future.”

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome