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Over the past week, the FDA issued final guidance on acceptable intake limits for nitrosamines and draft guidances on QTc information in human prescription drug and biological product labeling, classification categories for biosimilars, formal meetings for biosimilars and postmarketing approaches in clinical trials. Read More
The FDA’s Quality System Regulation mandates that devicemakers have procedures for documenting, verifying and validating all design changes before they are implemented. Read More
A federal appeals court handed another win to Axonics in its ongoing battle with Medtronic over claims that Medtronic’s patents for a sacral-nerve stimulation device are invalid. Read More
Cybersecurity patches — both proactive to address potential threats and reactive to respond to threats that have already occurred — can be expected to be part of any connected device’s lifecycle. But in the medical device world, these patches constitute design changes, which are strictly regulated, says Eric Henry, a senior quality systems and compliance adviser in the law firm King & Spalding. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as the GMP Quality Management vSummit and webinars from FDAnews, a WCG company on reliability assessment and medical device risk management tools. Read More
The center has received more submissions for novel devices over the past twelve months than during any 12-month period since the FDA began tracking in 2015. Read More
Pharmaceutical and medical device companies should not be held liable for terrorist actions after providing medical products to the Iraqi government, says an amicus brief from the U.S. Chamber of Commerce and PhRMA filed to the U.S. Supreme Court. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More
The company says customers should return any inventory that is not implanted and report any adverse reactions or quality problems to Abbott or the FDA. Read More