by Michele Taylor | Jun 16, 2016
The FDA has been working to improve the process used by physicians to request Expanded Access — Compassionate Use to investigational drugs and biologics for their patients who need these therapies to stay alive. In a statement released in early June from FDA...
by Michele Taylor | Jun 16, 2016
FDA’s recent public meeting on June 10th discussing a user fee program for over-the-counter (OTC) drugs indicates new activity in this program. Expert opinion was heard at the meeting with the acknowledgement that this is a very enormous undertaking with a small staff...
by Michele Taylor | May 25, 2016
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...
by Michele Taylor | May 9, 2016
FDA issued a draft guidance in April with recommendations on using a Comparability Protocol (CP) when implementing a chemistry, manufacturing and controls (CMC) postapproval change.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...
by Michele Taylor | May 6, 2016
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...
