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

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 ...

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

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 ...

Zeiss Medical Technology (ZMT) has announced that its MEL® 90 ophthalmology system has received approval from the U.S. Food and Drug Administration (FDA), giving the excimer laser ... the advancements ...

"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 ...

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.

The FDA has granted 510(k) clearance to AI Optics’ Sentinel Camera, a handheld retinal imaging system that captures high-quality images without the need for dilation, according to a press release.