North America
By Michael Rugnetta– The FDA wants to encourage the development of Health IT and Mobile Apps and has expressed a hands-off approach for low-risk forms of those technologies. Is that the right approach for the FDA to take? And how hands off exactly? What can...
Europe
This chart lists the pharmaceutical, medical and related regulatory authorities of Commonwealth of Independent States (CIS) countries along with links to their relevant websites.
Africa
This chart lists the pharmaceutical, medical and related regulatory authorities of MENA regulations countries along with links to their relevant websites.
North America
Recently a wide range of X-ray and computerized tomography technology were discovered to be acutely vulnerable. According to researcher Scott Erven, an unnamed organization exposed intelligence on over 68,000 systems, causing alarm. Erven noted that passwords to such...
Europe
Last Friday, after a three year gridlock, the Council of the European Union came to an agreement on the reworking of regulatory legislation on medical devices and in vitro diagnostics which will impact both manufacturers and regulatory authorities. The European...
North America
by Priya Bhutani, CEO RegDesk – Summary Technical Document (STED) is the proposed harmonized format used for regulatory submissions by the Global Harmonization Task Force (GHTF). Albeit STED is in its pilot phase, it has the potential to standardize format for...
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