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The frequent electronic exchange of health data through wireless, internet and networks along with the cybersecurity threats and vulnerabilities is driver for an FDA final guidance making recommendations for cybersecurity information to be submitted with premarket applications to CDRH and CBER. Read More
This European Edition of Quick Notes includes guidelines from WHO for pharmaceutical quality control laboratories, UK launch of the Innovative Devices Access Pathway pilot, European Commission (EC) unannounced antitrust inspections at a medical device company and an open letter to the EC about MDR and IVDR. Read More
The FDA has deemed Hamilton Ventilators’ recall of its C1, C2, C3, T1 ventilators as class I, as the company has received reports of software issues that may cause the ventilators to stop without notice, with the potential for serious injury or death. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More
Despite positive and sometimes emotional testimony from diabetes patients, an FDA advisory committee voted Thursday to uphold CDER’s recommendation that the new drug application for ITCA 650 (exenatide in DUROS device), Intarcia Therapeutics’s diabetes drug/device combo, be denied approval. Read More
In this edition of Quick Notes, we cover innovative medical devices including a mixed reality system for surgical navigation, robotic system for use in an MRI, a headband EEG and a point-of-care system to detect cardiac disease. Read More
As lawmakers fail to reach a deal to extend funding past the critical deadline of Sept. 30, the possibility of a government shutdown looms, threatening operations at the FDA and other government agencies. Read More
Over the past week, the FDA issued final guidance on conducting clinical trials during major disruptions due to disasters and public health emergencies. Draft guidances were issued on biosimilar and interchangeable biosimilar labeling, demonstrating evidence of effectiveness with one clinical investigation, considerations for prescription drug use-related software, assessing drug manufacturing facilities identified in pending applications and formal meetings between the FDA and pharmaceutical sponsors or applicants. Read More