North America
Theranos FDA Scandal: A Closer Look
The difference between CLIA and FDA standards
RegDesk Regulatory Roundup
North America
North America
Is Selling an Unauthorized Product Worth the Risk?
Many manufacturers believe that selling their product or device without FDA approval is acceptable. If people buy it, but is this breach in ethics worth the potential consequences? If caught marketing an unapproved product, the FDA may issue a warning letter...
South America
5 Medical Labeling Requirements In Brazil
Here are steps for proper device labeling in Brazil: The Brazilian Consumer protection code requires that product labeling should provide the consumer with accurate, concise and easily readable information. about the product’s quality, quantity, composition,...
North America
4 Factors Slowing US Approval of Biosimilars and the Future of the Biosimilar Market
As the patents for current biologics expire and the biosimilar industry begins to gain traction it is important to look at the future of the biosimilar market while noting hold-backs within the US manufacturing and approval processes. According to Research and...
North America
Increased Fees for FDA Issued Medical Device Exportation Certificates
The FDA has announced an increase in fees for assessing and exporting medical devices. The FDA Export Reform and Enhancement Act of 1996 enables manufacturers to request that the FDA issue a certification stating that their device meets certain requirements within 20...
North America
FDA Clears a Material Enabling 3D-Printing of Dentures
Dentca, a dental laboratory, received its first clearance from the FDA for a 3D printed resin that can be used as a base material during the manufacturing process for dentures. This is a huge step in the regulatory world because it is accepting 3D printing as an...
