US Food and Drug Administration. guidance for industry: Q10 quality systems qpproach to pharmaceutical cGMP regulations (FDA, Rockville, MD, September 2006).

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including a unique device RefluxStop ...

FDA and DOJ also took action based on longstanding ... Maintaining a culture of compliance and a mature quality system is the best way to detect and mitigate medical product and food safety ...

20% of bioreactor runs at the Genzyme facility failed due to contamination or quality issues over 2.5 years. FDA identified 84 overdue deviation investigations, some exceeding 180 days ...

Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a U.S. drug ingredients plant tied to its longstanding subsidiary Genzyme.

"FDA grants 510(k) clearance to GE HealthCare’s updated ultrasound systems" was originally created and published by Medical Device Network, a GlobalData owned brand. The informa ...