North America
Mobile health app The growing significance of mobile health apps result in a need to ensure its proper regulation. Practitioners, patients, researchers and medical industries are all affected by mHealth apps. The digital health field is regulated by the FDA under four...
North America
The difference between CLIA and FDA standards
North America
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...
North America
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
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...
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