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When communicating about the efficacy and risks of prescription and OTC drugs directly to consumers, quantitative information “can improve consumers’ accuracy in estimating the drug’s benefits and risks” and should be “accurate and understandable” says the FDA in a final guidance issued Tuesday. Read More
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
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. 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
Over the past week, the FDA issued final guidance on oncology drug products used with certain in vitro diagnostic tests and draft guidance on formal dispute resolution and administrative hearings procedures. Read More
Vitang Technology, a Tustin, Calif.-based manufacturer of 3D printed dental alignment devices, failed to seek the FDA’s clearance when it changed the software used with its UniSmile Clear Aligner, the agency said in a June 12 warning letter to the company. Read More