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This week, the FDA published eight medical device classifications — cardiovascular, dental (2), hematology and pathology, neurologic, ophthalmic, orthopedic and physical medicine. Final guidance was issued on nitrosamine impurities. The agency also asked for information for future guidance on model-informed drug development. Read More
This edition of Quick Notes features announcements of UCB’s divestiture of its Chinese neurology and allergy business and collaborations between Bayer and NextRNA, Flagship Pioneering and Pfizer, and Adcendo and Multitude Therapeutics. Read More
Richmond, Calif.-based Berkeley Biologics failed to file BLAs for several bone matrix products distributed to medical facilities nationwide and lacked proper screening for tissue donors, among other serious lapses cited in an FDA Warning Letter. Read More
The FDA urges API and drug manufacturers to adopt a three-step mitigation strategy to prevent high levels of nitrosamine impurities, in a new revised guidance. Read More
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
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