The FDA’s Medical Imaging Drug Advisory Committee (MIDAC) meets Tuesday to tackle concerns about Lumisight, a device-injection combo product from Lumicell designed to help clinicians detect residual breast cancer following…

The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with…

When it comes to integrating artificial intelligence into healthcare networks, stakeholder enthusiasm appears to be outstripping FDA oversight, according to a survey by the Berkeley Research Group. Source: Drug Industry…

This edition of Quick Notes looks at the FDA alerts and letters regarding artificial ankle failures, operating tables moving unexpectedly and unlatched incubator panels. Source: Drug Industry Daily

Over the past week, the FDA issued a final guidance on reporting the amount of listed drugs and biological products. Source: Drug Industry Daily

Bankrupt Endo Health Solutions (EHSI) has agreed to plead guilty and pay just over $2 billion to resolve criminal and civil investigations, as well as its bankruptcy debt, related to…

The U.S. government should have to prove that the claims in False Claims Act (FCA) kickback cases would not have been submitted “but for” kickbacks, says Teva Pharmaceuticals in response…

Medtronic has filed a patent infringement lawsuit against Axonics in two venues and also faces a Class I recall of its Duet system used to drain cerebrospinal fluid. Source: Drug…

The FDA’s draft guidance describing how device manufacturers can use real-world evidence (RWE) to support regulatory applications is a good start, but needs some refinement to avoid becoming a burden…

The FDA has issued warning letters to three eye drop manufacturers as part of ongoing investigations into a multi-state outbreak of more than 80 antibiotic-resistant eye infections that have led…