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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. Read More
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 Robert Califf. Read More
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 U.S. market more innovative for devicemakers. Read More
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 5.8.0 LVP software. Read More
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. Read More
The European Medicines Agency (EMA) has released a document detailing how the agency’s real-world evidence (RWE) office can help with medical research. Read More
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 the CDC. Read More
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 growth has earned Soulaire, a Santa Monica, Calif., devicemaker, an FDA Warning Letter. Read More
The Pharmacy Care Management Association (PCMA), a national association representing pharmacy benefit managers, opposes state laws requiring PBMs to act in the best interests of health plans they serve, saying that contractual agreements are sufficient to ensure this fiduciary duty, according to a new report by the Government Accountability Office (GAO). Read More
CDRH has unveiled a new dataset to help improve chemical characterization methods for biocompatibility of medical devices as part of its efforts to reduce the burden of premarket processes and increase the consistency and transparency of biocompatibility assessment methods. Read More
Three Eugia Pharma plants in India have received Form 483s following inspections conducted in the last two months, all laden with examples of the company failing to follow procedures to prevent microbiological contamination of its drug products, among other lapses. Read More