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I am good friends with a woman with Parkinson’s disease. When I see her, I feel grateful that this is the most exciting time in history for medical advancements. The drugs she is taking clearly are extending her good “on” time so that she has extended periods during the day when she can function with daily activities. I also have seen the difference between good “on” time and “off” time, when the medications start wearing off. Read More
Unauthorized sharing of users’ health data with several third parties — including Google — has gotten fertility app developer Easy Healthcare a $100,000 fine and a federal court order to protect consumer data. Read More
Two years after its repeal of a rule that would have expedited Medicare coverage for FDA-cleared Breakthrough Devices, CMA Thursday issued a request for comment on a process to provide “transitional coverage for emerging technologies” (TCET). Read More
After five years of development, a program to help devicemakers improve and accelerate their corrective and preventive action (CAPA) programs is ready to implement but its creators worry the industry will not be ready to adopt the model. Read More
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
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
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