by Charlie Perrecone | Oct 30, 2013
Louise Zornoza reports on Raps.org that on September 24, 2013, the European Commission issued new rules creating a new EU process for designating and monitoring Notified Bodies. The new rules establish the basis for withdrawal and clarify the required expertise of...
by Charlie Perrecone | Oct 30, 2013
Smartphones and biotech are not closely related subjects but Nick Paul Taylor, of fiercebiotechit.com, explains that app centers powered by Google, Microsoft, and Blackberry are closing the gap on Apple’s dominance in the app marketplace. Big Pharma and biotech apps...
by Charlie Perrecone | Oct 11, 2013
The 2013 Site Solutions Summit features Pearl Pathways’ own Diana Caldwell. She will be involved in the roundtable discussions as a panelist and moderator for topics such as: Investigator Insider: What your site needs to know about your next potential investigator;...
by Charlie Perrecone | Sep 27, 2013
According to Alexander Gaffney of raps.org FDA confesses that the guidance process is slow and not accessible. Complaints pertaining to lack of transparency and length of time before guidances are in full effect have led FDA to release the Level 1, IIE guidance...
by Charlie Perrecone | Sep 27, 2013
Alexander Gaffney of raps.org details that the US Food and Drug Administration (FDA) is ready to launch a new work group, the Program Alignment Group (PAG). The goal in creating PAG is to streamline efforts from various organizations and centers of FDA to avoid...