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FDA Issues Official Withdrawal of Proposed Rule Concerning Public Disclosure of Unapproved Gene Therapies
Two weeks ago, the US Food and Drug Administration (FDA) announced the withdrawal of a proposed rule from 2001. The rule would have required the public disclosure of summaries of safety and effectiveness data from pre-market clinical trials of gene therapies and...
Experienced quality analyst joins Pearl Pathways
Pearl Pathways is excited to announce the hiring of Phillip Bishop as a quality analyst. Bishop will help the Pearl team serve medical device and biopharmaceutical companies. Bishop brings 13 years of quality control (QC) laboratory experience to the Pearl Pathways...
Holiday season hours of operation for Pearl IRB
As we enter the holiday season, please keep in mind of our operating hours. Pearl IRB will not hold a full board meeting on November 23rd but meetings will resume as scheduled the following week. The office will be open during normal business hours (8 AM – 5 PM EST)...
Purdue professor to host free webinar for RAPS members: Emerging Issues in Manufacturing with Impact on Quality
On Thursday, November 17th, Purdue University’s professor of Medicinal Chemistry, Dr. Stephen R Byrn, will host a free webinar exclusive for members of the Indiana Regulatory Affairs Professionals Society (RAPS) Chapter. Members may register for the webinar here.
Recent analysis suggests that large molecule clinical trials taking longer and costing more
KMR Group recently concluded an analysis spanning ten years, from 2005 to 2015, that evaluated cycle time performance for more than 17,000 interventional trials. The analysis investigates clinical trial differences by molecule type and shows an increase in both length...