Our Blog

Never miss a thing! The latest regulatory news and updates are always on our feed.

Slider
This week, the FDA’s Center for Devices and Radiological Health (CDRH) announced its plans to create new regulations that would blend together two leading approaches to auditing medical device quality management...
After a warning from the United States Food and Drug Administration (FDA) against using oral forms of anesthetic benzocaine in children under two for teething pain, Australia’s Therapeutic Goods Association (TGA)...
A rare disease is defined by the U.S. Food and Drug Administration as a disease or condition that affects less than 200,000 Americans. Because rare diseases occur in such small numbers of patients, gathering the amount...
On September 11, 2018, a memorandum of understanding (MoU) was signed by the heads of Swissmedic and the Netherlands Medicines Evaluation Board (MEB).  This MoU allows for a better and more stable collaboration between...
“So is RegDesk essentially a regulatory consulting firm?” Questions like these haunt everyone on the RegDesk team. More often than not, inquisitors are quick to slap the “consulting firm” label onto the RegDesk name...