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To better understand the performance of the in vitro diagnostic tests used to identify the right treatment for cancer patients, the FDA has begun a pilot project for CDER-regulated oncology drugs and the corresponding clinical assays. Read More
The FDA’s list of regulations it plans to propose or finalize in the next 12 months, released Tuesday, includes more than 30 proposed and final rules related to drug, device and biologics products. Target release dates vary by rule. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
An artificial intelligence platform can discern epileptic seizure patterns on electroencephalogram as well as an expert epileptologist, with nearly 100 percent accuracy, a finding that could extend expert diagnoses to clinics without access to specialists in epilepsy, according to a report in JAMA Neurology. Read More
Failure to establish corrective and preventive action (CAPA) plans tops the list of devicemakers’ FDA inspection observations year after year, but the situation is more nuanced than you might expect, according to one regulatory expert. Read More
The issue concerns whether third-party entities should have access to copyrighted software so they are able to repair FDA-regulated medical devices. Read More
A dozen states have signed on to Illumina’s appeal of the Federal Trade Commission’s (FTC) order that the company divest itself of Grail — developer of the Galleri early cancer screening test — arguing that the commission’s process in the case was unconstitutional. Read More
Potential device issues include diminished battery life, overheating, connectivity issues with the device’s smartphone app and leakage of corrosive chemicals. Read More
The National Association of Manufacturers (NAM) and the Washington Legal Foundation (WLF) have entered the “right to repair” legal fray, questioning the Library of Congress’s (LOC) ability to grant copyright exemptions to third-party repair companies without the opportunity for judicial review. Read More