North America
The FDA finalized guidance regarding the use of placebos and blinding during randomized cancer trials. The guidance finalizes a draft made in 2018 and clarifies scenarios where placebo designs and blindings should be justified. WHAT IS A PLACEBO? A placebo is an inert...
North America
The FDA is in the process of implementing the Unique Device Identification (UDI) System in a series of phases. Currently, all Class III and implantable, life-supporting and life-sustaining medical devices require UDIs. The next phase of the system will be implemented...
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
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
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,...
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