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While three of the companies warned of inappropriate Orange Book patent listings by the FTC are delisting all the challenged patents, according to the U.S. legislators who led the action, five others refused to delist. Read More
AdvaMed has published seven “foundational” principles to guide innovations, policymaking and regulation in AI and machine learning (ML) for medtech as part of an information blitz that includes an overview paper and a list of AI facts and myths. Read More
Smartwatches and smart rings that claim to measure blood glucose levels without piercing the skin have not been authorized, cleared or approved by the FDA, the agency has warned in a recent safety communication. Read More
Small medical device manufacturers who are experiencing financial hardship — and are in an active bankruptcy — can look to a new FDA draft guidance for information on how to become eligible for a waiver of their registration fee. Read More
The General Accountability Office (GAO) should press the FDA to stop being passive in its oversight of device safety and instead take a more bold and active role, according to several academicians who collaborated on an opinion piece in the peer-reviewed healthcare journal Health Affairs. Read More
Using the app for two four-hour periods of sleep during the same 10-day period should provide enough data for users to have an informed conversation with a healthcare provider. Read More
Over the past week, the FDA issued a final rule on BLAs and master files. Final Guidance was issued on charging for investigational drugs under an IND. Draft guidance was issued on use of data monitoring committees. Product specific guidances were published. The agency also announced continuation of its site visit training program for its regulatory project managers, extended the comment period for the draft guidance on master protocols for drug and biological product development and amended a request for nominations for voting members for the Genetic Metabolic Diseases advisory committee. Read More