Over the past week, the FDA issued final guidance on informed consent and premarket notification for magnetic resonance devices and extended the comment period for a draft guidance on demonstrating…

A biotech in Friday Harbor, Wash., has been warned by the FDA for failing to report the findings of a phase 2 trial of a combination product for relieving lower…

After nine years in draft form and 127 comments received from stakeholders, the FDA has finalized its guidance on informed consent, adding a question-and-answer section that addresses specific issues. Source:…

A federal appeals court has taken action to allow the abortion medication Mifeprex and its mifepristone generic forms to stay on the market, with the same restrictions that existed before…

Beyond the regulatory requirement to perform them, regular internal audits can benefit quality, productivity and an organization’s bottom line. But if you’re simply going through the motions of an internal…

Medtronic’s June recall of its Mahurkar Acute Triple Lumen and Mahurkar Acute High Pressure Triple Lumen Catheters, the third recall of the company’s hemodialysis catheters in a year, has been deemed class…

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…