Recent clearances and approvals of medical devices include not just new versions of existing products, but entirely different ways to provide care for both complex illnesses and common needs. Source:…

The FDA has reprimanded AstraZeneca for making false and misleading claims about its chronic lung inflammatory inhalation therapy Breztri Aerosphere (budesonide, glycopyrrolate and formoterol fumarate), while the agency has also…

Make sure to submit electronic or written comments on a guidance by the closing date is the first tip given by CDRH in a list, released Aug. 16, of tips,…

A July 10-20 FDA inspection of a Biocon manufacturing facility in Malaysia turned up eight observations including a repeat observation of failure to follow procedures that prevent microbiological contamination of…

Upcoming events in the coming weeks include seven FDA advisory committee meetings as well as the the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, and a…

Amgen and Horizon have launched a return volley in their battle with the FTC, asking the U.S. District Court of Northern Illinois to deny the FTC’s July motion that sought…

In a recent court filing, HHS lambasted the U.S. Chamber of Commerce’s recent call to slow down implementation of pricing negotiations within the Inflation Reduction Act (IRA), calling the group’s…

This first European Edition of Quick Notes includes a PDUFA date extension for a chikungunya vaccine candidate, NICE approved AI technologies for radiotherapy treatment therapies, Novartis cited for claims made…

The FDA has classified the most recent recall of certain Philips Trilogy ventilators as class I, the most serious type of recall as use of the device may lead to…

Incorporating off-the-shelf (OTS) software into medical devices is becoming more common but a new guidance from the FDA advises that when using prepared software from another manufacturer, devicemakers still bear…