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This edition of Quick Notes features FDA clearances that expand the indications of a device to treat Type 2 diabetes, label changes that eliminate aspirin use for heart pump patients, use AI and robotics to treat enlarged prostates, and a new device to collect bone marrow aspirate. Read More
A new pooled analysis published in The Lancet demonstrated a reduced risk of combined cardiovascular death or worsening heart failure when treated with semaglutide. Read More
The FDA fired off Warning Letters to four companies — two in China and two in the U.S. — for marketing CPAP cleaning and sanitizing devices without clearance or approval. Read More
Although US gene sequencing giant Illumina finally spun-out Grail this summer following backlash to its $8 billion acquisition of the American liquid biopsy company in 2021, it’s getting some reprieve following an appeal to the European Court of Justice, which reached a judgment that clears out nearly half a billion dollars in fines. Read More
This excerpt is from the management report titled “Managing Data and Documentation for FDA Inspections and Remote Assessments,” based on an FDAnews webinar presentation by David Chesney, a former director of the FDA’s San Francisco District Office who is now principal and general manager of DL Chesney Consulting. Read More
Including quantitative descriptions and information about serious adverse effects in direct-to-consumer (DTC) ads for a fictional Alzheimer’s medication heightened patients’ apprehensions about the drug, a new survey in JAMA Network Open shows, suggesting regulators may wish to begin requiring ads for these medicines to prominently display this information. Read More
The FDA has issued a request for information (RFI) for advancing model-informed drug development (MIDD) to assist CDER and CBER in identifying and prioritizing potential focus areas for future policy or guidance development. Read More
The FDA has updated its technical guide for sponsors of NDAs or BLAs on submitting clinical trial datasets to CDER’s bioresearch monitoring (BIMO) program. Read More
Semaglutide treatment of overweight or obese individuals does not increase the risk of developing depression or suicidal thoughts or actions, a team of researchers in the US, UK and Denmark reported. Read More
This edition of Quick Notes provides approval notes on Janssen’s and AstraZeneca’s treatments for non-small cell lung cancer, FDA’s clinical hold on BioNTech’s HER3 anti-drug conjugate and “tentative” approval of Yutrepia. Read More
A host of issues found during a recent inspection of Indian API manufacturer Global Calcium, including falsified and duplicated records, have led the FDA to issue a Form 483. Read More
The FDA has reclassified four types of devices from the automatic class III designation to class II (special controls), and in each case the agency says the reclassification will provide a reasonable assurance of safety and effectiveness as well as enhance patients’ access to beneficial innovative devices. Read More