To detect, prevent and manage medicine shortages in the EU and European Economic Area (EEA), the European Medicines Agency (EMA) will create a new system to gather information about medicine…

This week, the FDA announced the establishment of the CDER Center for Clinical Trial Innovation (C3TI). Source: Drug Industry Daily

This edition of Quick Notes looks at FDA clearances and classifications for devices involving cranial implants, Parkinson’s Disease symptoms, at-home blood sampling and robotic microsurgery. Source: Drug Industry Daily

The fact that China manufactures almost all of the active pharmaceutical ingredients (API) used to make drugs for Americans could be a threat to national security, according to FDA Commissioner…

The FDA’s CDRH 2024 safety and innovation reports tout how the center has updated its 2018 Medical Device Safety Action Plan and regulated evolving technologies while working to make the…

A second recall of Fresenius Kabi’s Ivenix Infusion System this year has been classified Class I by the FDA due to multiple potentially life-threatening anomalies caused by the device’s version…

The FDA Oncology Center of Excellence has announced Project Asha, an initiative in collaboration with the White House Cancer Moonshot Program to increase oncology clinical trial access in India. Source:…

The European Medicines Agency (EMA) has released a document detailing how the agency’s real-world evidence (RWE) office can help with medical research. Source: Drug Industry Daily

Fake Botox has sent nine people to the hospital and caused harmful reactions in 10 others, prompting an FDA investigation and a warning about counterfeit forms of the neurotoxin from…

Marketing its cardiac device — intended to treat chronic angina — for un-cleared uses such as growth of new arteries, reduction of COVID-19 symptoms, regeneration of pancreatic tissue, and hair…