Despite boasting a new owner, the Indiana manufacturing plant Novo Nordisk picked up as part of its parent company's Catalent ...

A major U.S. drug manufacturing plant did not properly investigate cat hair, pests, and other problems, the FDA found in a ...

Before Novo arrived as its owner, issues at the Bloomington facility caused a two-month delay for Eylea HD’s FDA approval ...

FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers ...

This article focuses on practical strategies for medical device companies to strengthen their quality management systems and ...

The FDA noted, in a so-called form 483, that between April 2016 and January 2021, Philips was aware of 14 instances of issues related to potential foam degradation with its different sleep and ...

8. Communication During Submission Reviews The FDA’s final guidance issued April 4 outlines new communication “commitments” during the device review process to increase its transparency.

By Reuters April 19, 20179:12 AM UTCUpdated ago April 19 (Reuters) - Aurobindo Pharma Ltd * Clarifies on news item "US FDA issues 5-6 'largely procedural' observations to Aurobindo Pharma's Unit ...