Pearls of Wisdom
Sign up now for 2nd Annual Cell Therapy and Regenerative Medicine Symposium – June 13
Pearl Pathways is a proud supporter and sponsor of the 2nd Annual Cell Therapy and Regenerative Medicine Symposium to be held June 13, 2016 in Indianapolis, Indiana. The theme is commercialization and the title of this year's program is "Commercialization and Health...
Will we see you at the upcoming RAPS Indiana Chapter meeting, June 16th?
The RAPS Indiana Chapter, chaired by Pearl Pathways' COO & RAC, FRAPS, Gretchen Bowker, is hosting an evening of networking and expert presentation by Susan Resnick, PhD of 3D Communications. The presentation is entitled, "Practices and Preferences of CDRH...
Using Comparability Protocols for CMC postapproval changes
FDA issued a draft guidance in April with recommendations on using a Comparability Protocol (CP) when implementing a chemistry, manufacturing and controls (CMC) postapproval change. FDA defines a CP as a comprehensive plan for “assessing the effect of a proposed CMC...
Pearl Pathways proud sponsor of Indiana Life Sciences Collaboration Conference Series at Cook Medical World Headquarters, May 13th
Pearl Pathways continues to be a proud sponsor of the 2015-2016 Indiana Life Sciences Collaboration Conference Series, presented by the Kelley School’s Center for the Business of Life Sciences. This is an excellent forum bringing together key players in Indiana’s life...
Deadline fast approaching for Class II medical device compliance with UDI
September 24, 2016, a date fast approaching, is the deadline for Class II medical devices to be compliant with unique device identifier (UDI) regulations. For compliance, device manufacturers have to submit device identifiers (DI) to FDA for inclusion in the GUDID...