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Ophthalmology-focused biopharma EyePoint Pharmaceuticals received an FDA Warning Letter underscoring serious GMP violations at its Watertown, Mass., facility, mostly related to a one-time injection eye drug. Read More
The FDA offers updated advice to medical device sponsors on how to use patient preference information (PPI) throughout the product lifecycle, in a new draft guidance. Read More
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 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
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
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
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
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
This edition of Quick Notes features announcements of J&J’s acquisition of V-Wave, Paragonix Technologies’ sale to Getinge, Dupont’s purchase of Donatelle Plastics and Stryker’s deal to buy Vertos Medical. Read More
Sponsors appear more informed and prepared than sites for the upcoming changes to the ICH E6 — Good Clinical Practices guideline, according to a newly published survey by Avoca, a WCG company. Read More
The FDA has finalized guidance on the Voluntary Malfunction Summary Reporting (VMSR) program that allows manufacturers to submit medical device reports (MDRs) for certain low-risk devices to the agency on a quarterly basis instead of sending individual malfunction reports. Read More