North America
The FDA’s approval and hence availability of drug products can be expedited through a number of different approaches. An individual or combination of pathways may be suitable to the drug according to its compatibility to the pathway’s criteria.ÂÂ
North America
As the benefits of software become increasingly present to healthcare systems, its risks do too. While software can increase the efficiency and effectiveness of healthcare, it can also create greater vulnerabilities. The medical device industry in particular has had...
North America
Healthcare has always played a prominent role in presidential campaigns, and with good reasons. While the approaches and obstacles to reform can be addressed among multiple political parties, what remains undebatable is the fact that America’s healthcare system...
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
On January 1, 2013, the Internal Revenue Service (IRS) implemented a regulation that required companies to pay a 2.3% tax fee on some medical devices sold in the U.S. These medical devices did not apply to eyeglasses, contact lenses, hearing aids, or other equipment...
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