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The European Medicines Agency (EMA) reported “remarkable” progress, despite the pandemic, in a mid-point assessment of its “Regulatory Science Strategy to 2025” to build a more adaptive regulatory system that will encourage innovation — including advances in clinical trial innovation and a new real-world data (RWD) network. Read More
The FDA said it could not approve AbbVie’s new drug application (NDA) for ABBV-951 (foslevodopa/foscarbidopa), an investigational therapy for advanced Parkinson’s disease, because of concerns about the delivery device. Read More
Funding in the fiscal 2024 budget to make sure the U.S. is prepared for potential medical device shortages is one of the top concerns for the FDA’s Center for Devices and Radiological Health (CDRH), according to CDRH Director Jeff Shuren. Read More
The FDA, the American Society of Plastic Surgeons and the Plastic Surgery Foundation have added squamous cell carcinoma (SCC) in the capsule around breast implants to the PROFILE registry where healthcare providers can submit case reports of SCC and other breast cancers associated with breast implants.
Roche has teamed up with Eli Lilly to develop Roche’s Elecsys Amyloid Plasma Panel (EAPP), an investigational blood-based biomarker test designed to give patients an earlier Alzheimer’s disease diagnosis.
The FDA has updated its device shortage list to reflect changes in the estimated shortage durations for six categories of medical devices, continuing its monitoring of the supply chain in light of the high demand and shortages resulting from the COVID-19 public health emergency.
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