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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
Medline Industries’ recall of 18,000 saline solution vials due to being non-sterile has been deemed as class 1 by the FDA, the most serious type of recall, because use of the device may cause serious injuries or death. Read More
Much needs to be hammered out before the FDA can comfortably green light first-in-human studies of artificial womb devices for extremely premature infants, said several members of the FDA’s Pediatric Advisory Committee (PAC) on Tuesday. Read More
The FDA has expanded the scope of its guidance on conducting clinical trials during the COVID-19 pandemic to apply to public health emergencies (PHE) and other disasters, issuing final guidance that also includes several clarifications. Read More
CDRH, as part of its MDUFA V commitments, has released a draft plan to further its work toward globally harmonized medical device regulation, policy and practices as part of the effort to reduce redundant expectations and requirements among international regulatory bodies. Read More